Safety of PDT-Photofrin® Prior to Lung Surgery

• Sponsor: Concordia Laboratories Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03344861
• Collaborator: (none)
• Enrollment: 10
• Locations: 8
• Arm: 1
• Actual Duration (Months): 19.2
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This research study is being conducted to assess the safety of PDT in subjects with peripherally located malignant tumors in lung parenchyma prior to surgical resection. It will involve up to 10 sites in USA. Participation will last 4 months.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer; Lung Cancer Metastatic	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 been 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 lightning the abnormal area using a fiber optic device (very fine fiber [like a fishing line] that permits light transmission) inserted into a flexible tube with a light, called bronchoscope for the lung. The light activates the porfimer sodium concentrated in the abnormal tissue, leading to its destruction.

The purpose of this study is to assess the safety of using photodynamic therapy prior to surgical resection of tumors located in the periphery of the lung.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: A Multicenter, Prospective, Open-label, Non-randomized Single-arm Clinical Study of the Safety and Tissue Response to Photodynamic Therapy Using Porfimer Sodium for Injection as Treatment for Solid Lung Tumor Prior to Surgical Resection
• Actual Study Start Date: Aug 14, 2017
• Actual Primary Completion Date: Mar 22, 2019
• Actual Study Completion Date: Mar 22, 2019

Arms and Interventions

Arm

Intervention/Treatment

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

Drug: Porfimer Sodium; Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.; Other Names: Photofrin ; Device: Fiber optic; 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.

Outcome Measures

Primary Outcome Measures

1. Safety: Number of Participants With at Least One Adverse Event [108 days (to 3 months post surgery)]

   Safety evaluation will include incidence of all adverse events, including serious and non-serious. The count of how many subjects experienced at least one adverse event.

2. Safety: Physical Examination Summaries of Non-normal Findings for Each Subject [108 days (to 3 months post surgery)]

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

3. Safety: Vital Sign Summary of Abnormal Findings for Each Subject [108 days (to 3 months post surgery)]

   Safety evaluation will include vital sign summary for each subject. Only abnormal counts are included.

4. Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject [108 days (to 3 months post surgery)]

   Safety evaluation will include laboratory tests summarized for each subject with any abnormal lab results considered an AE (adverse event) to be listed.

5. Safety: Skin Photosensitivity Events Summaries of Abnormal Findings for Each Subject [108 days (to 3 months post surgery)]

   Safety evaluation will include incidence of skin photosensitivity summarized for each subject.

Secondary Outcome Measures

1. Macroscopic Tissue Examination [Day 13 to 18]

   The mean measurement of tumor size after surgery. The largest diameter seen is measured.

2. Summary of Microscopic Tissue Examination: Percentage of Participants With Complete Response After Surgery [Day 13 to 18]

   The Percentage of Participants with Complete Response in Tumor area (no non-viable/necrotic tumor) after surgery

3. Microscopic Tissue Examination: Percent Tumor Cell Necrosis in Tumor Area After Surgery [Day 13 to 18]

   The mean with standard deviation of the percent of tumor cell necrosis in the tumor area after surgery. The tumor itself was examined after it was removed to determine the percent of necrosis seen.

4. Microscopic Tissue Examination: Brisk Inflammatory Reaction After Surgery [Day 13 to 18]

   The number of participants showing a brisk inflammatory reaction in the tumor area after surgery. This is determined through a histological examination. Brisk Inflammatory Reaction is defined as lymphocytes that infiltrate diffusely the entire tumor and/or infiltrate across the entire base of the tumor.

5. Microscopic Tissue Examination: Number of Participants With Cavitation in Normal Lung Area After Surgery [Day 13 to 18]

   The number of participants with cavitation seen in the normal lung area from the microscopic tissue examination after surgery

6. Microscopic Tissue Examination: Number of Participants With Hemorrhage Seen After Surgery [Day 13 to 18]

   The Number of Participants with hemorrhage seen during the microscopic tissue examination after surgery

7. Microscopic Tissue Examination: Number of Participants With Pneumonitis in the Normal Lung After Surgery [Day 13 to 18]

   The Number of Participants with pneumonitis seen in the normal lung area after surgery following the microscopic tissue examination

8. Microscopic Tissue Examination: Number of Participants With Increased Alveolar Macrophages in the Normal Lung After Surgery [Day 13 to 18]

   The number of participants with increased alveolar macrophages post surgery determined in the microscopic tissue examination.

9. Microscopic Tissue Examination: Number of Participants With Atypical/Reactive Type 2 Pneumocytes in the Normal Lung After Surgery [Day 13 to 18]

   Number of Participants with Atypical/Reactive Type 2 pneumocytes seen in the normal lung after surgery during the Microscopic Tissue Examination:

10. Microscopic Tissue Examination: Number of Participants With Mucus Plugging/Mucositis in the Normal Lung After Surgery [Day 13 to 18]

    Number of Participants with Mucus Plugging/Mucositis seen in the normal lung after surgery during the Microscopic Tissue Examination.

11. Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery [Day 13 to 18]

    Number of participants with interstitial fibrosis in the normal lung after surgery seen during the Microscopic Tissue Examination

12. Microscopic Tissue Examination: Number of Participants With Necrosis in the Normal Lung After Surgery [Day 13 to 18]

    Number of Participants with Necrosis seen in the normal lung after surgery during the Microscopic Tissue Examination

13. Microscopic Tissue Examination: Number of Participants With Large Vessel Damage Indicated by Fibrinoid Necrosis, Thrombus, Vasculitis in the Normal Lung After Surgery [Day 13 to 18]

    Number of Participants with Large Vessel Damage indicated by fibrinoid necrosis, thrombus, vasculitis in the normal lung after surgery seen during Microscopic Tissue Examination

14. Microscopic Tissue Examination: Number of Participants With Acute Alveolar Damage in the Normal Lung After Surgery [Day 13 to 18]

    Number of Participants with Acute Alveolar damage in the normal lung after surgery seen during the Microscopic Tissue Examination

15. Microscopic Tissue Examination: Number of Participants With Organizing Pneumonia Pattern in the Normal Lung After Surgery [Day 13 to 18]

    Number of Participants with Organizing pneumonia pattern in the normal lung after surgery seen during Microscopic Tissue Examination

16. ECOG (Eastern Cooperative Oncology Group) Performance Status: Baseline [Baseline (-30 to -1 Days)]

    Number of Participants with ECOG Performance at Baseline showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).

17. ECOG Performance Status: Period 1 PDT Day 3 [Day 3]

    Number of Participants with ECOG Performance Status at Period 1 PDT Day 3, showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).

18. ECOG Performance Status: Period II Surgery (Day 13-18) [Day 13 to 18]

    Number of Participants with ECOG Performance Status at Period II Surgery (Day 13-18) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).

19. ECOG Performance Status: Period III Follow-up (Day 20-25) [Day 20 to 25]

    Number of Participants with ECOG Performance Status at Period III Follow-up (Day 20-25) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).

20. ECOG Performance Status: Period III Follow-up (Day 43 -48) [Day 43 to 48]

    Number of Participants with ECOG Performance Status at Period III Follow-up (Day 43 -48) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).

21. ECOG Performance Status: Period III Follow-up (Day 103 - 108) [108 days (to 3 months post surgery)]

    Number of Participants with ECOG Performance Status at Period III Follow-up (Day 103 - 108) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female aged 18-79

• Diagnosed with primary or metastatic tumor < 5 cm located in peripheral lung that can be completely resectable

• Candidate for surgical resection

• Candidate for bronchoscopy

• Tumor is accessible for unrestricted illumination of PDT

• Subject is deemed likely to survive for at least 3 months

• Non-menopausal/non-sterile female subject of childbearing potential has negative B-HCG (Human chorionic gonadotropin) at time of study entry

• Non-menopausal/non-sterile female subject of childbearing potential uses medically acceptable form of birth control

• Subject is able and willing to provide written informed consent to participate in the study, which must comply with ICH (International Council for Harmonisation) guidelines & local requirements

Exclusion Criteria:

• Diagnosis of small cell lung cancer or carcinoid tumors

• Primary or metastatic lung tumor located in central lung or near vertebral body

• Tumor invades a major blood vessel

• Presence of concurrent non-solid malignancy

• Tumor previously treated with radiation therapy

• Chemotherapy in the last four weeks

• Tumor treated with PDT within the last 3 months

• Abnormal blood results

• Subject with porphyria or hypersensitivity to Photofrin

• Coexisting ophthalmic disease likely to required slit-lamp exam within next 90 days

• Acute or chronic medical or psychological illness as judged clinical significant to PI to preclude bronchoscopy procedures

• female who is breast-feeding or intends to breast-feed during study

• subject who participated in another study within last 30 days or intends to participate in another study during this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
2	University of Colorado	Denver	Colorado	United States	80045
3	Moffitt Cancer Center	Tampa	Florida	United States	33612
4	Cancer Treatment Centers of America/Southeastern	Atlanta	Georgia	United States	30265
5	AMITA Health Alexian Brothers Medical Center	Elk Grove Village	Illinois	United States	60007
6	Dubois Medical Center	DuBois	Pennsylvania	United States	15801
7	UT MD Anderson Cancer Center	Houston	Texas	United States	77030
8	Providence Health & Services	Spokane	Washington	United States	99204

Sponsors and Collaborators

• Concordia Laboratories Inc.

Investigators

• Study Chair: Erin O'Neil, Concordia Laboratories Inc.

Study Documents (Full-Text)

• Study Protocol - Mar 1, 2017
• Statistical Analysis Plan - Apr 11, 2018

More Information

Publications

None provided.

• Responsible Party: Concordia Laboratories Inc.
• ClinicalTrials.gov Identifier: NCT03344861
• Other Study ID Numbers: CLI-PHO1701
• First Posted: Nov 17, 2017
• Last Update Posted: Jan 13, 2020
• Last Verified: Dec 1, 2019

• 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.: lung cancer; lung carcinoma; lung metastases
• Additional relevant MeSH terms: Lung Neoplasms; 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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Photofrin and Photodynamic Therapy
Arm/Group Description	Open label study. All subjects had a 1-time administration of Photofrin and 1-time use of navigational bronchoscopy-PDT.
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	7 70%
>=65 years	3 30%
Sex: Female, Male (Count of Participants)
Female	4 40%
Male	6 60%
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	0 0%
White	10 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	10 100%
Peripheral Lung Tumor (Count of Participants)
Count of Participants [Participants]	10 100%

Outcome Measures

1. Primary Outcome

Title	Safety: Number of Participants With at Least One Adverse Event
Description	Safety evaluation will include incidence of all adverse events, including serious and non-serious. The count of how many subjects experienced at least one adverse event.
Time Frame	108 days (to 3 months post surgery)

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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Count of Participants [Participants]	10 100%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Photodynamic Therapy-Photofrin
	Comments	Adverse events will be listed, coded by MedDRA, by system organ class and preferred term.
	Type of Statistical Test	Other
	Comments	No comparator arm.
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	exact Clopper-Pearson binomial method
	Comments	One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion.
Method of Estimation	Estimation Parameter	Clopper-Pearson (binomial proportion)
	Estimated Value	.05
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	One-sided 95% upper confidence limit for the event percentage was calculated using exact (Clopper-Pearson) method for binomial proportion

2. Secondary Outcome

Title	Macroscopic Tissue Examination
Description	The mean measurement of tumor size after surgery. The largest diameter seen is measured.
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

Photodynamic therapy - Photofrin

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Mean (Standard Deviation) [CM]	2.177 (0.8003)

3. Secondary Outcome

Title	Summary of Microscopic Tissue Examination: Percentage of Participants With Complete Response After Surgery
Description	The Percentage of Participants with Complete Response in Tumor area (no non-viable/necrotic tumor) after surgery
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

Look at complete response in the tumor area

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Number [percentage of participants]	20 200%

4. Secondary Outcome

Title	Microscopic Tissue Examination: Percent Tumor Cell Necrosis in Tumor Area After Surgery
Description	The mean with standard deviation of the percent of tumor cell necrosis in the tumor area after surgery. The tumor itself was examined after it was removed to determine the percent of necrosis seen.
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

All subjects were examined for percent tumor cell necrosis in the tumor area

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Mean (Standard Deviation) [Percent of tumor]	22.0 (17.67)

5. Secondary Outcome

Title	Microscopic Tissue Examination: Brisk Inflammatory Reaction After Surgery
Description	The number of participants showing a brisk inflammatory reaction in the tumor area after surgery. This is determined through a histological examination. Brisk Inflammatory Reaction is defined as lymphocytes that infiltrate diffusely the entire tumor and/or infiltrate across the entire base of the tumor.
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

The brisk inflammatory reaction percentage seen in the tumor area

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Count of Participants [Participants]	9 90%

6. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Cavitation in Normal Lung Area After Surgery
Description	The number of participants with cavitation seen in the normal lung area from the microscopic tissue examination after surgery
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

Number of participants with cavitation seen in normal lung area

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Count of Participants [Participants]	1 10%

7. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Hemorrhage Seen After Surgery
Description	The Number of Participants with hemorrhage seen during the microscopic tissue examination after surgery
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

Number of Participants with Hemorrhage seen in normal lung area after surgery

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Count of Participants [Participants]	6 60%

8. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Pneumonitis in the Normal Lung After Surgery
Description	The Number of Participants with pneumonitis seen in the normal lung area after surgery following the microscopic tissue examination
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

Microscopic Tissue Examination: Pneumonitis in the normal lung after surgery. Looked at Number of Participants with pneumonitis.

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Count of Participants [Participants]	2 20%

9. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Increased Alveolar Macrophages in the Normal Lung After Surgery
Description	The number of participants with increased alveolar macrophages post surgery determined in the microscopic tissue examination.
Time Frame	Day 13 to 18

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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Count of Participants [Participants]	10 100%

10. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Atypical/Reactive Type 2 Pneumocytes in the Normal Lung After Surgery
Description	Number of Participants with Atypical/Reactive Type 2 pneumocytes seen in the normal lung after surgery during the Microscopic Tissue Examination:
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

Number of Participants with Atypical/Reactive Type 2 Pneumocytes in the normal lung after surgery determined during the Microscopic Tissue Examination.

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Count of Participants [Participants]	10 100%

11. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Mucus Plugging/Mucositis in the Normal Lung After Surgery
Description	Number of Participants with Mucus Plugging/Mucositis seen in the normal lung after surgery during the Microscopic Tissue Examination.
Time Frame	Day 13 to 18

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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Count of Participants [Participants]	0 0%

12. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Interstitial Fibrosis in the Normal Lung After Surgery
Description	Number of participants with interstitial fibrosis in the normal lung after surgery seen during the Microscopic Tissue Examination
Time Frame	Day 13 to 18

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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Mild	0 0%
Moderate	1 10%
Severe	0 0%
None	9 90%

13. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Necrosis in the Normal Lung After Surgery
Description	Number of Participants with Necrosis seen in the normal lung after surgery during the Microscopic Tissue Examination
Time Frame	Day 13 to 18

Outcome Measure Data

Analysis Population Description

Number of Participants with Necrosis in the normal lung after surgery

Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Count of Participants [Participants]	3 30%

14. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Large Vessel Damage Indicated by Fibrinoid Necrosis, Thrombus, Vasculitis in the Normal Lung After Surgery
Description	Number of Participants with Large Vessel Damage indicated by fibrinoid necrosis, thrombus, vasculitis in the normal lung after surgery seen during Microscopic Tissue Examination
Time Frame	Day 13 to 18

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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Count of Participants [Participants]	1 10%

15. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Acute Alveolar Damage in the Normal Lung After Surgery
Description	Number of Participants with Acute Alveolar damage in the normal lung after surgery seen during the Microscopic Tissue Examination
Time Frame	Day 13 to 18

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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Count of Participants [Participants]	0 0%

16. Secondary Outcome

Title	Microscopic Tissue Examination: Number of Participants With Organizing Pneumonia Pattern in the Normal Lung After Surgery
Description	Number of Participants with Organizing pneumonia pattern in the normal lung after surgery seen during Microscopic Tissue Examination
Time Frame	Day 13 to 18

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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Count of Participants [Participants]	7 70%

17. Secondary Outcome

Title	ECOG (Eastern Cooperative Oncology Group) Performance Status: Baseline
Description	Number of Participants with ECOG Performance at Baseline showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame	Baseline (-30 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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
ECOG 0	7 70%
ECOG 1	3 30%

18. Secondary Outcome

Title	ECOG Performance Status: Period 1 PDT Day 3
Description	Number of Participants with ECOG Performance Status at Period 1 PDT Day 3, showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
ECOG 0	6 60%
ECOG 1	4 40%

19. Secondary Outcome

Title	ECOG Performance Status: Period II Surgery (Day 13-18)
Description	Number of Participants with ECOG Performance Status at Period II Surgery (Day 13-18) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame	Day 13 to 18

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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
ECOG 0	7 70%
ECOG 1	3 30%

20. Secondary Outcome

Title	ECOG Performance Status: Period III Follow-up (Day 20-25)
Description	Number of Participants with ECOG Performance Status at Period III Follow-up (Day 20-25) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame	Day 20 to 25

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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
ECOG 0	0 0%
ECOG 1	9 90%
ECOG 2	1 10%

21. Secondary Outcome

Title	ECOG Performance Status: Period III Follow-up (Day 43 -48)
Description	Number of Participants with ECOG Performance Status at Period III Follow-up (Day 43 -48) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame	Day 43 to 48

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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
ECOG 0	7 70%
ECOG 1	3 30%

22. Secondary Outcome

Title	ECOG Performance Status: Period III Follow-up (Day 103 - 108)
Description	Number of Participants with ECOG Performance Status at Period III Follow-up (Day 103 - 108) showing the number of participants at each ECOG level. ECOG is Eastern Cooperative Oncology Group. ECOG has 6 levels (0-5). Level 0 is the best status (fully active, able to carry on all pre-disease performance without restriction); Level 1 is mildly restricted (Restricted in physically strenuous activity but ambulatory ad able to carry out work of a light or sedentary nature, e.g. light house work, office work); Level 2 is more restricted (Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours); Level 3 is restricted (Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours); Level 4 is highly restricted (completely disabled; cannot carry on any selfcare; totally confined to bed or chair); and Level 5 is death (dead).
Time Frame	108 days (to 3 months post surgery)

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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
ECOG 0	9 90%
ECOG 1	1 10%

23. Primary Outcome

Title	Safety: Physical Examination Summaries of Non-normal Findings for Each Subject
Description	Safety evaluation will include the physical examinations summary of non-normal findings for each subject.
Time Frame	108 days (to 3 months post surgery)

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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Respiratory abnormal at screening	1 10%
Respiratory abnormal at Follow-up (Day 103-108)	3 30%
Mouth abnormal at Follow-up (day 103-108)	1 10%

24. Primary Outcome

Title	Safety: Vital Sign Summary of Abnormal Findings for Each Subject
Description	Safety evaluation will include vital sign summary for each subject. Only abnormal counts are included.
Time Frame	108 days (to 3 months post surgery)

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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Count of Participants [Participants]	0 0%

25. Primary Outcome

Title	Safety: Laboratory Tests Summaries of Abnormal Findings for Each Subject
Description	Safety evaluation will include laboratory tests summarized for each subject with any abnormal lab results considered an AE (adverse event) to be listed.
Time Frame	108 days (to 3 months post surgery)

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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Albumin (105-04) Period 1: 32 (drop of 10)	1 10%
Lab values with no clinically significant change	9 90%

26. Primary Outcome

Title	Safety: Skin Photosensitivity Events Summaries of Abnormal Findings for Each Subject
Description	Safety evaluation will include incidence of skin photosensitivity summarized for each subject.
Time Frame	108 days (to 3 months post surgery)

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 porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
Measure Participants	10
Count of Participants [Participants]	4 40%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Photodynamic Therapy-Photofrin
	Comments	All adverse event terms are coded using MedDRA Dictionary version 21.1. NCS (Non-Clinical Significant) events were not included in the summary because their CTCAE grade and relationship were not collected. Subjects are counted once within each system organ class and each preferred term. An AE is defined as treatment related if its relationship to the study drug is recorded as "reasonable possibility" on the CRF (Case Report Form).
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	exact Clopper-Pearson binomial method
	Comments	One-sided 95% upper confidence limit for the event percentage, calculated using exact (Clopper-Pearson) method for binomial proportion.

Adverse Events

Time Frame	Each subject was on study for 108 days. Study subjects were on study for 1 year 6 months in total (10Aug2017 to 7Feb2019).
Arm/Group Title	Photodynamic Therapy-Photofrin
Arm/Group Description	Photodynamic therapy (PDT) involves the i.v. injection of porfimer sodium (Photofrin®) followed by illumination of the tumor using a fiber optic device during navigational bronchoscopy. Two days after the injection, the laser light will be applied to the tumor. Porfimer Sodium: Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg. Fiber optic: 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). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
All Cause Mortality
	Photodynamic Therapy-Photofrin
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Photodynamic Therapy-Photofrin
	Affected / at Risk (%)	# Events
Total	4/10 (40%)
Blood and lymphatic system disorders
Hemorrhagic Shock	1/10 (10%)	1
Anemia	1/10 (10%)	1
Deep Vein Thrombosis (DVT) Right	1/10 (10%)	1
Deep Vein Thrombosis Left	1/10 (10%)	1
Cardiac disorders
Atrial Fibrillation	1/10 (10%)	1
Gastrointestinal disorders
Gastrointestinal haemorrhage	1/10 (10%)	1
Gastro-oesophageal reflux disease	1/10 (10%)	1
Infections and infestations
Sepsis	1/10 (10%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	1/10 (10%)	1
Respiratory, thoracic and mediastinal disorders
Pleural effusion	1/10 (10%)	1
Hypoxia	1/10 (10%)	1
Haemothorax	1/10 (10%)	1
Dyspnoea	1/10 (10%)	1
Pneumonia aspiration	1/10 (10%)	1
Other (Not Including Serious) Adverse Events
	Photodynamic Therapy-Photofrin
	Affected / at Risk (%)	# Events
Total	10/10 (100%)
Cardiac disorders
Bradycardia	2/10 (20%)	3
Tachycardia	1/10 (10%)	1
Congenital, familial and genetic disorders
Congenital diaphragmatic hernia	1/10 (10%)	1
Gastrointestinal disorders
Constipation	2/10 (20%)	2
Gastritis	1/10 (10%)	1
Nausea	2/10 (20%)	2
Vomiting	1/10 (10%)	1
General disorders
Tenderness	1/10 (10%)	1
Injury, poisoning and procedural complications
Procedural Pain	2/10 (20%)	3
Investigations
Blood albumin decreased	4/10 (40%)	4
Blood alkaline phosphatase decreased	1/10 (10%)	2
Blood creatinine decreased	2/10 (20%)	4
Blood creatinine increased	5/10 (50%)	7
Blood glucose increased	3/10 (30%)	6
Blood pressure increased	3/10 (30%)	8
Blood pressure decreased	1/10 (10%)	2
Blood urea abnormal	2/10 (20%)	3
Blood urea increased	1/10 (10%)	1
Chest x-ray abnormal	1/10 (10%)	2
False negative investigation result	3/10 (30%)	6
Hematocrit decreased	2/10 (20%)	2
Hematocrit increased	2/10 (20%)	2
Hemoglobin decreased	3/10 (30%)	4
Hemoglobin increased	2/10 (20%)	2
Heart rate increased	1/10 (10%)	1
Platelet count increased	1/10 (10%)	1
Protein total decreased	1/10 (10%)	1
Prothrombin time abnormal	2/10 (20%)	2
Prothrombin time prolonged	2/10 (20%)	2
Red blood cell count decreased	2/10 (20%)	2
Red blood cell count increased	1/10 (10%)	1
Respiratory rate increased	1/10 (10%)	1
White blood cell count increased	2/10 (20%)	4
x-ray abnormal	1/10 (10%)	1
Blood Sodium increased	1/10 (10%)	1
Prothrombin time shortened	1/10 (10%)	1
Metabolism and nutrition disorders
Hyperglycaemia	1/10 (10%)	2
Hyperkalaemia	1/10 (10%)	2
Hypokalaemia	2/10 (20%)	2
Hyponatraemia	1/10 (10%)	2
Protein deficiency	1/10 (10%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma	1/10 (10%)	1
Lung neoplasm malignant	1/10 (10%)	2
Neoplasm	2/10 (20%)	2
Respiratory, thoracic and mediastinal disorders
Atelectasis	4/10 (40%)	4
Dyspnoea	1/10 (10%)	4
Hypoxia	1/10 (10%)	2
Pneumothorax	5/10 (50%)	7
Respiratory abnormal	1/10 (10%)	1
Pleural effusion	6/10 (60%)	7
Skin and subcutaneous tissue disorders
Swelling Face	1/10 (10%)	1
Facial Blisters	1/10 (10%)	1
Forearm Erythema	2/10 (20%)	2
Hand Erythema	1/10 (10%)	1
Facial erythema	2/10 (20%)	3
Erythema on calves	1/10 (10%)	1
Abdomen erythema	1/10 (10%)	1
Hyperhidrosis	1/10 (10%)	1
Surgical and medical procedures
Thoracic operation	1/10 (10%)	1
Vascular disorders
Hypertension	2/10 (20%)	6
Hypotension	1/10 (10%)	2

Limitations/Caveats

[Not Specified]

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.