Feasibility Study of Using Navigational Bronchoscopy to Perform PDT-Photofrin® in Unresectable Peripheral Lung Cancer

• Sponsor: Concordia Laboratories Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02916745
• Collaborator: (none)
• Enrollment: 5
• Locations: 7
• Arm: 1
• Actual Duration (Months): 26.5
• Patients Per Site: 0.7
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This research study is being conducted to assess the safety and feasibility of using a new developed bronchoscopic technology called electronavigational bronchoscopy to treat subjects with solid tumor in peripheral lung, who are inoperable or refused surgery. It will involve 10 sites in USA and Canada. Participation will last 6 months.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer (NSCLC); Lung Metastasis	Drug: Porfimer sodium; Device: Fiber optic	Phase 1

Detailed Description

Lung cancer accounts for almost one-third of cancer deaths. Cancer screening strategies have the potential to achieve a 20% reduction in death rates. Newly developed bronchoscopic technologies (such as navigational bronchoscopy) have shown to enable physicians to safely reach lesions in peripheral regions of the lung and obtain diagnosis. This new technology may now potentially offer bronchoscopic therapeutic interventions, such as photodynamic therapy, to tumors that were previously unreachable due to their peripheral anatomic location.

Photodynamic therapy (PDT) uses a combination of a photosensitizing drug (a drug that is activated by light), called porfimer sodium (Photofrin®), and a light from a laser that emits no heat. This technique works to allow the medical doctor to specifically target and destroy abnormal or cancer cells while limiting damage to surrounding healthy tissue. The activation of the drug is done by lighting the abnormal area using a fiber optic device (very fine fiber [like a fishing line] that permits light transmission) inserted into a flexible tube called bronchoscope. The light activates the porfimer sodium, which is concentrated in the abnormal tissue, leading to its destruction.

The purpose of this study is to determine if physicians can reach the tumors in the periphery of the lung via electronavigational bronchoscopy and deliver the photodynamic therapy by placing the optical fiber into the tumor.

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Multicenter, Prospective, OL, Single-arm Clinical Study of Safety & Feasibility of Using Navigational Bronchoscopy to Perform Interstitial PD Therapy Using Photofrin® as Treatment in Subjects With Unresectable Solid Tumor in Peripheral Lung
• Actual Study Start Date: Jan 26, 2017
• Actual Primary Completion Date: Apr 12, 2019
• Actual Study Completion Date: Apr 12, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Photodynamic therapy-Photofrin Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor.

Drug: Porfimer sodium; After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.; Other Names: Photofrin ; Device: Fiber optic; A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.

Outcome Measures

Primary Outcome Measures

1. Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor [Day 3 post-treatment]

   Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.

2. Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT) [Up to 6 months]

   The incidence of adverse events following navigational bronchoscopy-iPDT (interstitial-Photodynamic Therapy) will be presented as the primary safety indicator for this treatment.

Secondary Outcome Measures

1. Tumor Response at 3 Months Post Photodynamic Therapy (PDT) [Up to 3 months]

   From the start of treatment until 3 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria

2. Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT) [Up to 6 months]

   From the start of treatment until 6 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria

3. Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline. [up to day 0 (-14 to -1 days)]

   Measured at screening to be the baseline measure. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.

4. Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection). [1 day]

   Measured at Day 1 which is day of the photofrin injection. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.

5. Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy) [Day 3]

   Measured at Day 3. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.

6. Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection) [Day 30]

   Measured at Day 3. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.

7. Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection [up to 3 months]

   Measured at 3 months. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.

8. Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection [Up to 6 months]

   Measured at 6 months. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.

9. Short Form Health Survey (SF-36) Score at Baseline [Baseline]

   The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.

10. Short-Form Health Survey (SF-36) Score at Follow-up Visit at 3 Months. [up to 3 months]

    The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.

11. Short-Form Health Survey (SF-36) Score at Study Exit (6 Month Visit) [Up to 6 months]

    The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.

12. Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline [Baseline]

    Baseline score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from "not at all" to "very much". Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.

13. Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months [up to 3 months]

    3 month score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from "not at all" to "very much". Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.

14. Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months [Up to 6 months]

    6 month score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from "not at all" to "very much". Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.

15. Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score [Baseline]

    Baseline measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.

16. Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score [up to 3 months]

    3-Month measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.

17. Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score [Up to 6 months]

    6-Month measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.

18. Number of Participants With Indicated Adverse Events [Up to 6 months post-treatment]

    Adverse events (AEs) noted by number of participants with at least one event. An AE was defined as any untoward medical occurrence in a subject during the course of the study, regardless of causal relationship. AEs were coded using MedDRA Version 21.1

19. Number of Subjects With at Least One Serious Adverse Event [Up to 6 months]

    The number of subjects with at least one serious adverse event are listed.

20. Safety: Physical Examination Summaries for Each Subject [Up to 6 months]

    Safety evaluation will include the physical examinations summary of non-normal findings for each subject.

21. Safety: Number of Participants With Indicated Vital Sign Summaries [Up to 6 months]

    Safety evaluation included vital sign summary for each subject. Vital signs included pulse, blood pressure, temperature and respiration rate. Only clinically relevant results, as per the investigator judgement, are included. These would be vital signs that are out of the normal range but could be considered outside enough to be clinically relevant to the subject's health.

22. Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events [Up to 6 months]

    The treatment emergent adverse events related to PFTs are noted. Pulmonary function test measurements were: Diffusion Capacity of Lung for Carbon Monoxide (%), Expiratory Reserve Volume (mL), Forced Vital Capacity (mL), Forced Expiratory Volume in 1 second (mL), Forced Expiratory Flow 25% to 75% (L/min), Functional Residual Capacity (mL), Maximum Voluntary Ventilation (L/min), Residual Volume (mL), Peak Expiratory Flow (L/min), Slow Vital Capacity (mL), Total Lung Capacity (mL)

23. Safety: Laboratory Test Summaries for Each Subject [Up to 6 months]

    Safety evaluation includes laboratory tests summarized for each subject with any abnormal lab results considered an Adverse Event to be listed. The investigators commented on any laboratory value outside the normal reference range. If the value was judged to be an Adverse Event, it is listed. The values analysed were: Hematology (Hemoglobin, Hematocrit, White Blood Cell, Red Blood Cell, Platelet Count, Prothrombin Time) and Chemistry (Glucose (random), Blood Urea Nitrogen, Electrolytes (sodium, potassium, chloride), Creatinine, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase, Total Bilirubin, Albumin, Total Protein)

Other Outcome Measures

1. Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported. [Baseline, 10 days post-treatment]

   Distribution of lymphocyte subsets from peripheral blood was determined by flow cytometry. Flow cytometry is a laser-based technique used to detect and measure physical and chemical characteristics of a population of cells or particles. It allows simultaneous multi-parameter analysis of single cells. The selected markers of interest, representative of the broader markers were: Total Thymus-cells (T-Cells), Cluster of Differentiation 4 (CD4) T cell subsets, and Cluster of Differentiation 9 (CD8) T cell subset, CD4 T Regulatory (T Reg) cells, Natural Killer Cells, Activated T cells, Myeloid-Derived Suppressor Cells (MSCDs), Monocytes. The Percent Gated and Absolute counts were analysed for each marker. Gating allows the analysis to be restricted to a specific size of cells (e.g. lymphocytes) to allow a more specific analysis. Absolute counting quantifies the total number of cells. It is recommended to look at both values to get the full picture.

2. Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event [Up to 6 months]

   Adverse Event of special interest was Skin Photosensitivity. Skin photosensitivity was examined because all subjects who receive Photofrin are photosensitive and must observe precautions to avoid exposure of eyes and skin to direct sunlight or bright indoor lights for 30 days or longer. Changes in skin will be assessed by grade of erythema, edema and blistering and will be tabulated by Common Terminology Criteria for Adverse Events (CTCAE) grade in the dermatology/skin category.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female aged 18 or older

• Diagnosed with histologically confirmed solid tumor located in the peripheral lung

• Not candidate for curative surgery, is unfit for surgery, or does not wish to undergo curative surgery

• May be candidate for, have failed, or does not wish to undergo radiation therapy

• The tumor is ≤ 3 cm in size and clearly observable in computerized tomography (CT scan)

• Able to sign an informed consent

Exclusion Criteria:

• Diagnostic of small cell lung cancer

• Solid tumor located in central lung

• Presence of concurrent non-solid malignancy

• Abnormal blood results

• Received chemotherapy/immunotherapy in the last 4 weeks

• Tumor invades a major blood vessel

• Porphyria or known hypersensitivity to Photofrin® or porphyrin-like compounds or to any of its excipients

• Planned surgical procedure within the next 90 days

• Coexisting ophthalmic disease likely to require slit-lamp examination within the next 90 days

• Acute or chronic medical or psychological illnesses that prevent endoscopy procedures

• Pregnant or intend to become pregnant, breastfeeding or intend to breastfeed during the study

• Received PDT during the past 3 months

• Severe impairment of your kidney or liver function

• Participates or intends to participate in another drug study (other than observational studies) during the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32611
2	Southeastern Regional Medical Center	Atlanta	Georgia	United States	30265
3	Alexian Brothers Hospital Network	Elk Grove Village	Illinois	United States	60007
4	Southwestern Regional Medical Center	Tulsa	Oklahoma	United States	74133
5	Providence Medical Research Center	Spokane	Washington	United States	99204
6	University of Wisconsin-Madison	Madison	Wisconsin	United States	53715
7	Toronto General Hospital	Toronto	Ontario	Canada	M5G2C4

Sponsors and Collaborators

• Concordia Laboratories Inc.

Investigators

• Study Director: Michelle Depot, Ph.D., at the request of Concordia Laboratories Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 26, 2017

More Information

Publications

None provided.

• Responsible Party: Concordia Laboratories Inc.
• ClinicalTrials.gov Identifier: NCT02916745
• Other Study ID Numbers: CLI-PHO1601
• First Posted: Sep 27, 2016
• Last Update Posted: Mar 4, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Concordia Laboratories Inc.: Non-small cell lung cancer; NSCLC; lung cancer; lung carcinoma; lung metastasis
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Dihematoporphyrin Ether; Trioxsalen

Study Results

Participant Flow

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Period Title: Overall Study
STARTED	5
COMPLETED	5
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the intravenous injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Overall Participants	5
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	4 80%
>=65 years	1 20%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.75 (6.99)
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.75 (6.99)
Sex: Female, Male (Count of Participants)
Female	4 80%
Male	1 20%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 20%
White	4 80%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	5 100%
Peripheral Lung Tumor (centimetre) [Mean (Standard Deviation) ]
Primary Tumor size - baseline	1.70 (0.762)
Metastatic Tumor size - baseline	1.50 (0)

Outcome Measures

1. Primary Outcome

Title	Feasibility to Perform Interstitial-Photodynamic Therapy (i-PDT) Into Tumor
Description	Number of times photodynamic therapy was delivered into the tumor using navigational bronchoscopy for each subject.
Time Frame	Day 3 post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
One delivery of PDT into tumor	3 60%
Two deliveries of PDT into tumor	0 0%
Three deliveries of PDT into tumor	1 20%
Four deliveries of PDT into tumor	1 20%

2. Primary Outcome

Title	Adverse Events Incidence Indicating Safety of Navigational Bronchoscopy-interstitial-Photodynamic Therapy (i-PDT)
Description	The incidence of adverse events following navigational bronchoscopy-iPDT (interstitial-Photodynamic Therapy) will be presented as the primary safety indicator for this treatment.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Total number of participants with AEs	5 100%
AE of Blood creatinine increased	2 40%
AE of blood glucose increased	2 40%
AE of heart rate increased	2 40%
AE of laboratory test abnormal	3 60%
AE of pulmonary function test abnormal	3 60%
AE of respiratory rate increased	2 40%
Erythema	2 40%
Atelectasis	2 40%

3. Secondary Outcome

Title	Tumor Response at 3 Months Post Photodynamic Therapy (PDT)
Description	From the start of treatment until 3 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Time Frame	Up to 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Complete Response	1 20%
Partial Response	0 0%
Stable Response	4 80%
Progression of Disease	0 0%
Any response (Complete + Partial)	1 20%

4. Secondary Outcome

Title	Tumor Response at Study Exit (6 Months) Post Photodynamic Therapy (PDT)
Description	From the start of treatment until 6 months post-treatment measured as per the Modified RECIST (Response Evaluation Criteria in Solid Tumors) Criteria
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Complete Response	1 20%
Partial Response	0 0%
Stable Response	3 60%
Progression of Disease	1 20%
Any response (Complete + Partial)	1 20%

5. Secondary Outcome

Title	Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Screening (Days -14 to -1). Baseline.
Description	Measured at screening to be the baseline measure. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Time Frame	up to day 0 (-14 to -1 days)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
ECOG value of 0	1 20%
ECOG value of 1	2 40%
ECOG value of 2	2 40%
ECOG value of 3	0 0%
ECOG value of 4	0 0%
ECOG value of 5	0 0%

6. Secondary Outcome

Title	Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 1 (Date of Photofrin Injection).
Description	Measured at Day 1 which is day of the photofrin injection. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
ECOG value of 0	1 20%
ECOG value of 1	4 80%
ECOG value of 2	0 0%
ECOG value of 3	0 0%
ECOG value of 4	0 0%
ECOG value of 5	0 0%

7. Secondary Outcome

Title	Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 3 (Day of Photodynamic Therapy)
Description	Measured at Day 3. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Time Frame	Day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	4
ECOG value of 0	0 0%
ECOG value of 1	3 60%
ECOG value of 2	1 20%
ECOG value of 3	0 0%
ECOG value of 4	0 0%
ECOG value of 5	0 0%

8. Secondary Outcome

Title	Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at Day 30 (30 Days Post Photofrin Injection)
Description	Measured at Day 3. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
ECOG value of 0	1 20%
ECOG value of 1	2 40%
ECOG value of 2	2 40%
ECOG value of 3	0 0%
ECOG value of 4	0 0%
ECOG value of 5	0 0%

9. Secondary Outcome

Title	Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 3 Months Post Photofrin Injection
Description	Measured at 3 months. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Time Frame	up to 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
ECOG value of 0	2 40%
ECOG value of 1	2 40%
ECOG value of 2	1 20%
ECOG value of 3	0 0%
ECOG value of 4	0 0%
ECOG value of 5	0 0%

10. Secondary Outcome

Title	Performance Status on the Eastern Cooperative Oncology Group (ECOG) Score at 6 Months Post Photofrin Injection
Description	Measured at 6 months. The Eastern Cooperative Oncology Group (ECOG) scores range from 0 to 5. The lowest values mean a better outcome: 0 is fully active with no performance restrictions; 1 is strenuous physical activity restricted but fully ambulatory and able to carry out light work; 2 is capable of all self-care but unable to carry out any work activities - up and about >50% of waking hours; 3 is capable of only limited self-care and confined to bed or chair >50% of waking hours; and 4 is completely disable, cannot carry out any self-care and totally confined to bed or chair.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
ECOG value of 0	3 60%
ECOG value of 1	1 20%
ECOG value of 2	1 20%
ECOG value of 3	0 0%
ECOG value of 4	0 0%
ECOG value of 5	0 0%

11. Secondary Outcome

Title	Short Form Health Survey (SF-36) Score at Baseline
Description	The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Physical Component Score (PCS)	49.27 (6.71)
Mental Component Score	29.47 (3.13)

12. Secondary Outcome

Title	Short-Form Health Survey (SF-36) Score at Follow-up Visit at 3 Months.
Description	The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.
Time Frame	up to 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Physical Component Score (PCS)	46.83 (5.60)
Mental Component Score (MCS)	30.04 (8.64)

13. Secondary Outcome

Title	Short-Form Health Survey (SF-36) Score at Study Exit (6 Month Visit)
Description	The Short-Form Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status. SF-36 evaluates 9 dimensions of Health: physical function, role limitations due to physical health problems, body pain, general health, vitality, social functioning, role limitations due to emotional problems domain, and mental health. Summary is provided in the form of physical component score (PCS) and mental component score (MCS) for each of the timepoints.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Physical Component Score (PCS)	48.33 (7.45)
Mental Component Score (MCS)	31.90 (9.61)

14. Secondary Outcome

Title	Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Baseline
Description	Baseline score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from "not at all" to "very much". Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Global Health Status	55.0 (28.62)
Physical Functioning	73.34 (10.55)
Role Functioning	60.02 (30.27)
Emotional Functioning	80.0 (17.29)
Cognitive Functioning	76.66 (18.99)
Social Functioning	70.0 (41.50)
Fatigue	24.44 (25.35)
Nausea and Vomiting	3.34 (7.47)
Pain	43.34 (27.91)
Dyspnoea	53.32 (44.73)
Insomnia	20.0 (29.82)
Appetite Loss	26.64 (14.89)
Constipation	6.66 (14.89)
Diarrhoea	6.66 (14.89)
Financial Difficulties	46.66 (50.56)

15. Secondary Outcome

Title	Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): Follow-up 3 Months
Description	3 month score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from "not at all" to "very much". Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.
Time Frame	up to 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Global Health Status	70.0 (17.29)
Physical Functioning	68.0 (20.76)
Role Functioning	63.34 (24.73)
Emotional Functioning	80.02 (12.63)
Cognitive Functioning	73.34 (18.99)
Social Functioning	80.0 (21.72)
Fatigue	28.86 (12.66)
Nausea and Vomiting	6.66 (14.89)
Pain	30.0 (29.82)
Dyspnoea	60.0 (27.91)
Insomnia	13.32 (18.24)
Appetite Loss	26.66 (27.90)
Constipation	20.0 (29.82)
Diarrhoea	26.66 (27.90)
Financial Difficulties	33.32 (40.83)

16. Secondary Outcome

Title	Health-related Quality of Life on the 4- and 7-point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Item (QLQ-C30): 6 Months
Description	6 month score of EORTC QLQ-C30 which is a multi-dimensional Health Related Quality of Life measure designed for use in lung cancer patients. Includes 5 functional measures (physical, role, emotional, social, cognitive), 8 symptoms (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, dyspnea) and global health status and financial impact. Most items use 4-item scale from "not at all" to "very much". Raw scores are transformed to 0-100 scale with higher scores representing better functioning/Quality of Life and greater symptom burden.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Global Health Status	71.66 (20.07)
Physical Functioning	58.66 (22.80)
Role Functioning	66.68 (35.34)
Emotional Functioning	75.0 (22.03)
Cognitive Functioning	76.66 (9.09)
Social Functioning	76.68 (14.89)
Fatigue	28.88 (21.67)
Nausea and Vomiting	0 (0)
Pain	36.66 (13.94)
Dyspnoea	53.34 (38.02)
Insomnia	13.32 (18.24)
Appetite Loss	19.98 (18.24)
Constipation	13.32 (18.24)
Diarrhoea	13.32 (18.24)
Financial Difficulties	33.32 (40.83)

17. Secondary Outcome

Title	Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Baseline Score
Description	Baseline measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Dyspnea	39.98 (24.36)
Coughing	33.32 (23.58)
Haemoptysis	6.66 (14.89)
Sore Mouth	6.66 (14.89)
Dysphagia	20.0 (29.82)
Peripheral Neuropathy	19.98 (18.24)
Alopecia	33.34 (47.15)
Pain in Chest	6.66 (14.89)
Pain in Arm or Shoulder	19.98 (18.24)
Pain in Other Parts	40.0 (27.91)

18. Secondary Outcome

Title	Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Follow-up 3 Month Score
Description	3-Month measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.
Time Frame	up to 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Dyspnea	40.0 (24.37)
Coughing	26.64 (14.89)
Haemoptysis	0 (0)
Sore Mouth	13.32 (18.24)
Dysphagia	13.32 (18.24)
Peripheral Neuropathy	19.98 (18.24)
Alopecia	26.66 (43.46)
Pain in Chest	6.66 (14.89)
Pain in Arm or Shoulder	19.98 (18.24)
Pain in Other Parts	66.66 (33.35)

19. Secondary Outcome

Title	Health-related Quality of Life on the 4- Point European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Lung Cancer 13 Item (QLQ-LC13): Study Exit (6 Months) Score
Description	6-Month measure for EORTC QLQ-LC13 which is a 13-item lung cancer-specific questionnaire module. It is used in conjunction with the QLQ-C30. It is comprised of multi-item and single-item measures of lung cancer associated symptoms (coughing, hemoptysis, dyspnea, pain) and side effects from conventional chem-and radiotherapy (alopecia, neuropathy, sore mouth, dysphagia). For these symptom-oriented scales, a higher score means more severe symptoms. The scale is from 1 (not at all) to 4 (very much). The scoring (as reported here) is from 0 to 100 with the higher score meaning a more severe symptom.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Dyspnea	40.0 (30.04)
Coughing	39.98 (14.94)
Haemoptysis	0 (0)
Sore Mouth	6.66 (14.89)
Dysphagia	23.66 (43.46)
Peripheral Neuropathy	33.32 (23.58)
Alopecia	26.66 (43.46)
Pain in Chest	6.66 (14.89)
Pain in Arm or Shoulder	40.0 (27.91)
Pain in Other Parts	26.66 (27.9)

20. Secondary Outcome

Title	Number of Participants With Indicated Adverse Events
Description	Adverse events (AEs) noted by number of participants with at least one event. An AE was defined as any untoward medical occurrence in a subject during the course of the study, regardless of causal relationship. AEs were coded using MedDRA Version 21.1
Time Frame	Up to 6 months post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Porphyria Grade 2	1 20%
Eye oedema grade 1	1 20%
Dysphagia grade 1	1 20%
Asthenia Grade 1	1 20%
Oedema peripheral grade 1	1 20%
Fall grade 1	1 20%
Trunk injury grade 1	1 20%
Blood pressure increased grade 1	2 40%
Breath sounds abnormal grade 1	1 20%
Carbon monoxide diffusing capacity decreased gr. 1	1 20%
Creatinine renal clearance abnormal gr. 1	1 20%
Heart rate increased grade 1	1 20%
Oxygen saturation decreased grade 1	1 20%
Pulmonary function test abnormal grade 1	2 40%
Respiratory rate increased grade 1	2 40%
Back pain grade 1	1 20%
Atelectasis grade 1	2 40%
Pleural effusion grade 1	1 20%
Dermatitis grade 1	1 20%
Erythema grade 1	1 20%
Erythema grade 2	1 20%
Hyperkeratosis grade 1	1 20%
Photosensitivity reaction grade 2	1 20%
Pruritus grade 1	1 20%
Rash grade 1	1 20%
Skin exfoliation grade 1	1 20%
Flushing grade 1	1 20%

21. Secondary Outcome

Title	Number of Subjects With at Least One Serious Adverse Event
Description	The number of subjects with at least one serious adverse event are listed.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Count of Participants [Participants]	0 0%

22. Secondary Outcome

Title	Safety: Physical Examination Summaries for Each Subject
Description	Safety evaluation will include the physical examinations summary of non-normal findings for each subject.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Abnormal eyes at 3 month follow-up	1 20%
Abnormal nose, throat, ears and mouth at day 3	1 20%
Abnormal skin at screening	2 40%
Abnormal skin at Day 1	2 40%
Abnormal skin at Day 3	2 40%
Abnormal skin at Day 5	1 20%
Abnormal skin at day 10	4 80%
Abnormal skin at day 30	3 60%
Abnormal skin at 3 months	1 20%
Abnormal skin at 6 months	1 20%
Abnormal respiratory at screening	1 20%
Abnormal respiratory at day 1	2 40%
Abnormal respiratory at day 3	2 40%
Abnormal respiratory at day 5	2 40%
Abnormal respiratory at day 10	1 20%
Abnormal respiratory at day 30	2 40%
Abnormal respiratory at 3 months	2 40%
Abnormal respiratory at 6 months	1 20%
Abnormal abdomen/Gastrointestinal Day 1	1 20%
Abnormal abdomen/Gastrointestinal 3 months	1 20%
Abnormal neurological at screening	1 20%

23. Secondary Outcome

Title	Safety: Number of Participants With Indicated Vital Sign Summaries
Description	Safety evaluation included vital sign summary for each subject. Vital signs included pulse, blood pressure, temperature and respiration rate. Only clinically relevant results, as per the investigator judgement, are included. These would be vital signs that are out of the normal range but could be considered outside enough to be clinically relevant to the subject's health.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Blood pressure increased study day 180 grade 1	1 20%
Respiratory rate increased study day 180 grade 1	1 20%
Respiratory rate increased day 3 grade 1	1 20%
Heart rate increased day 5 grade 1	1 20%
Blood pressure increased day 31 grade 1	1 20%

24. Secondary Outcome

Title	Safety: Number of Participants With Indicated Changes to Pulmonary Function Tests (PFTs) Related to Treatment Emergent Adverse Events
Description	The treatment emergent adverse events related to PFTs are noted. Pulmonary function test measurements were: Diffusion Capacity of Lung for Carbon Monoxide (%), Expiratory Reserve Volume (mL), Forced Vital Capacity (mL), Forced Expiratory Volume in 1 second (mL), Forced Expiratory Flow 25% to 75% (L/min), Functional Residual Capacity (mL), Maximum Voluntary Ventilation (L/min), Residual Volume (mL), Peak Expiratory Flow (L/min), Slow Vital Capacity (mL), Total Lung Capacity (mL)
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Carbon Monoxide Diffusing Capacity down Day 92 g.1	1 20%
Expiratory Reserve Volume decreased Day 92 grade 1	1 20%
Forced Expiratory Volume abnormal Day 92 grade 1	1 20%
Forced Vital Capacity Abnormal Day 92 Grade 1	1 20%
Carbon Monoxide Diffusing Capacity down 3 mos. g.1	1 20%
Expiratory Reserve Volume decreased 3 mos. grade 1	1 20%
Forced Expiratory Volume abnormal 3 mos. grade 1	1 20%
Forced Vital Capacity Abnormal 3 mos. Grade 1	1 20%
Oxygen Saturation decreased Day 5 grade 1	1 20%

25. Secondary Outcome

Title	Safety: Laboratory Test Summaries for Each Subject
Description	Safety evaluation includes laboratory tests summarized for each subject with any abnormal lab results considered an Adverse Event to be listed. The investigators commented on any laboratory value outside the normal reference range. If the value was judged to be an Adverse Event, it is listed. The values analysed were: Hematology (Hemoglobin, Hematocrit, White Blood Cell, Red Blood Cell, Platelet Count, Prothrombin Time) and Chemistry (Glucose (random), Blood Urea Nitrogen, Electrolytes (sodium, potassium, chloride), Creatinine, Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase, Total Bilirubin, Albumin, Total Protein)
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
High post-baseline alkaline phosphatase	2 40%
High Alkaline Phosphatase value from baseline	1 20%
High post-baseline alanine transaminase	1 20%
High aspartate transaminase from baseline	1 20%
High creatinine levels from baseline	2 40%
High post-baseline glucose levels	1 20%
High glucose levels from baseline	3 60%
High urea nitrogen post baseline	2 40%
High protein post baseline	1 20%
High post baseline hematocrit	1 20%
Low hematocrit values from baseline	2 40%
Low erythrocyte count from baseline	2 40%
High erythrocyte count from baseline	1 20%
High leukocyte count from baseline	1 20%
High leukocyte at baseline & then normal post base	1 20%

26. Other Pre-specified Outcome

Title	Immunology Markers Concentrations Were Examined as an Exploratory Endpoint. The Change From Baseline Was Reported.
Description	Distribution of lymphocyte subsets from peripheral blood was determined by flow cytometry. Flow cytometry is a laser-based technique used to detect and measure physical and chemical characteristics of a population of cells or particles. It allows simultaneous multi-parameter analysis of single cells. The selected markers of interest, representative of the broader markers were: Total Thymus-cells (T-Cells), Cluster of Differentiation 4 (CD4) T cell subsets, and Cluster of Differentiation 9 (CD8) T cell subset, CD4 T Regulatory (T Reg) cells, Natural Killer Cells, Activated T cells, Myeloid-Derived Suppressor Cells (MSCDs), Monocytes. The Percent Gated and Absolute counts were analysed for each marker. Gating allows the analysis to be restricted to a specific size of cells (e.g. lymphocytes) to allow a more specific analysis. Absolute counting quantifies the total number of cells. It is recommended to look at both values to get the full picture.
Time Frame	Baseline, 10 days post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
CD45+ cells Percent gated increased	2 40%
CD45+ cells Percent gated decreased	3 60%
CD45+ cells Absolute Count increased	2 40%
CD45+ cells Absolute Count decreased	3 60%
Helper T cells Percent Gated Increased	3 60%
Helper T cells Percent Gated Decreased	1 20%
Helper T cells Percent Gated stayed the same	1 20%
Helper T cells Absolute counts Increased	1 20%
Helper T cells Absolute counts Decreased	4 80%
CD3+, CD4+ T cells Percent Gated increased	4 80%
CD3+, CD4+ T cells Percent Gated decreased	1 20%
CD3+, CD4+ T cells Absolute Counts increased	1 20%
CD3+, CD4+ T cells Absolute Counts decreased	4 80%
T Reg Cells Percent Gated increased	3 60%
T Reg Cells Percent Gated decreased	1 20%
T Reg Cells Percent Gated similar	1 20%
T Reg Cells Absolute Counts increased	1 20%
T Reg Cells Absolute Counts decreased	4 80%
Cytotoxic T Cells Percent Gated increased	1 20%
Cytotoxic T Cells Percent Gated decreased	3 60%
Cytotoxic T Cells Percent Gated similar	1 20%
Cytotoxic T Cells Absolute Counts increased	1 20%
Cytotoxic T Cells Absolute Counts decreased	4 80%
Natural Killer Cells Percent Gated increased	2 40%
Natural Killer Cells Percent Gated decreased	1 20%
Natural Killer Cells Percent Gated Not Done	2 40%
Natural Killer Cells Absolute Counts increased	2 40%
Natural Killer Cells Absolute Counts decreased	1 20%
atural Killer Cells Absolute Counts Not Done	2 40%
Activated T Cells Percent Gated Increased	3 60%
Activated T Cells Percent Gated Decreased	2 40%
Activated T Cells Absolute Counts Increased	2 40%
Activated T Cells Absolute Counts Decreased	3 60%
TH17 Cytokines Percent Gated Increased	1 20%
TH17 Cytokines Percent Gated Decreased	2 40%
TH17 Cytokines Percent Gated Not Done	2 40%
TH17 Cytokines Absolute Counts Increased	2 40%
TH17 Cytokines Absolute Counts Decreased	3 60%
Monocytic MDSCs Percent Gated Increased	3 60%
Monocytic MDSCs Percent Gated Decreased	2 40%
Monocytic MDSCs Absolute Counts Increased	3 60%
Monocytic MDSCs Absolute Counts Decreased	2 40%
Granulocytic MDSCs Percent Gated Increased	3 60%
Granulocytic MDSCs Percent Gated Decreased	2 40%
Granulocytic MDSCs Absolute Counts Increased	3 60%
Granulocytic MDSCs Absolute Counts Decreased	2 40%
Monocytes Percent Gated Increased	4 80%
Monocytes Percent Gated Decreased	1 20%
Monocytes Absolute Counts Increased	3 60%
Monocytes Absolute Counts Decreased	2 40%

27. Other Pre-specified Outcome

Title	Skin Photosensitivity as a Adverse Event of Special Interest: Participants With Event
Description	Adverse Event of special interest was Skin Photosensitivity. Skin photosensitivity was examined because all subjects who receive Photofrin are photosensitive and must observe precautions to avoid exposure of eyes and skin to direct sunlight or bright indoor lights for 30 days or longer. Changes in skin will be assessed by grade of erythema, edema and blistering and will be tabulated by Common Terminology Criteria for Adverse Events (CTCAE) grade in the dermatology/skin category.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
Measure Participants	5
Erythema Grade 1 Events; related	1 20%
Erythema Grade 2 Events; related	1 20%
Photosensitivity Reaction Grade 2; related	1 20%
Rash grade 1; related	1 20%
Skin Exfoliation grade 1; related	1 20%
Flushing grade 1; related	1 20%

Adverse Events

Time Frame	6 months for each subject. The study was conducted over a period of 1 year and 5 months in total (29Nov2017 to 12Apr2019)
Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of 2 mg/kg-porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, a laser light will be applied to the tumor. Porfimer sodium: After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered. Fiber optic: A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
All Cause Mortality
	Photodynamic Therapy-Photofrin
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Serious Adverse Events
	Photodynamic Therapy-Photofrin
	Affected / at Risk (%)	# Events
Total	0/5 (0%)
Other (Not Including Serious) Adverse Events
	Photodynamic Therapy-Photofrin
	Affected / at Risk (%)	# Events
Total	5/5 (100%)
Congenital, familial and genetic disorders
Porphyria	1/5 (20%)	1
Eye disorders
Eye Oedema	1/5 (20%)	1
Gastrointestinal disorders
Dysphagia	1/5 (20%)	1
General disorders
Asthenia	1/5 (20%)	1
Peripheral Oedema	1/5 (20%)	4
Injury, poisoning and procedural complications
Fall	1/5 (20%)	1
Trunk Injury	1/5 (20%)	1
Investigations
Blood Creatinine Increased	2/5 (40%)	3
Blood Glucose Increased	2/5 (40%)	3
Blood Pressure Abnormal	1/5 (20%)	1
Blood Pressure Decreased	1/5 (20%)	1
Blood Pressure Diastolic Increased	1/5 (20%)	2
Blood Pressure Increased	2/5 (40%)	4
Blood Pressure Systolic Increased	1/5 (20%)	4
Breath Sounds Abnormal	1/5 (20%)	2
Carbon Monoxide diffusing capacity decreased	2/5 (40%)	3
Chest X-Ray Abnormal	1/5 (20%)	2
Creatinine Renal Clearance Abnormal	1/5 (20%)	1
Expiratory Reserve Volume decreased	1/5 (20%)	1
Forced Expiratory Volume abnormal	2/5 (40%)	3
Forced Vital Capacity abnormal	2/5 (40%)	2
Haematocrit decreased	1/5 (20%)	3
Haemoglobin decreased	1/5 (20%)	3
Heart Rate decreased	1/5 (20%)	2
Heart Rate increased	2/5 (40%)	2
Laboratory test abnormal	4/5 (80%)	7
Oxygen Consumption decreased	1/5 (20%)	5
Oxygen Saturation decreased	1/5 (20%)	2
Pulmonary Function Test abnormal	3/5 (60%)	5
Red Blood Cell Count Decreased	2/5 (40%)	7
Respiratory Rate increased	2/5 (40%)	4
White Blood Cell Count abnormal	1/5 (20%)	1
Electrocardiogram abnormal	1/5 (20%)	1
Blood Albumin increased	1/5 (20%)	1
Blood Urea increased	1/5 (20%)	1
Glomerular Filtration Rate abnormal	1/5 (20%)	1
Musculoskeletal and connective tissue disorders
Back Pain	1/5 (20%)	1
Respiratory, thoracic and mediastinal disorders
Atelectasis	2/5 (40%)	3
Pleural Effusion	1/5 (20%)	2
Skin and subcutaneous tissue disorders
Dermatitis	1/5 (20%)	1
Erythema	2/5 (40%)	11
Hyperkeratosis	1/5 (20%)	1
Photosensitivity reaction	1/5 (20%)	1
Pruritus	1/5 (20%)	1
Psoriasis	1/5 (20%)	2
Rash	1/5 (20%)	1
Skin Exfoliation	1/5 (20%)	1
Vascular disorders
Flushing	1/5 (20%)	1

Limitations/Caveats

Early termination of the study lead to small numbers of subject being analysed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.