A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRIGGER)

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01378962
• Collaborator: (none)
• Enrollment: 50
• Locations: 10
• Arm: 1
• Actual Duration (Months): 70.1
• Patients Per Site: 5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This single-arm, open-label study evaluated the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic non-small cell lung cancer. Participants received daily oral doses of 150 mg Tarceva. The anticipated time on study treatment was 12 months.

Condition or Disease	Intervention/Treatment	Phase
Non-Squamous Non-Small Cell Lung Cancer	Drug: erlotinib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II, Open-label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor (EGFR) - (TRIGGER)
• Actual Study Start Date: Mar 31, 2011
• Actual Primary Completion Date: Jun 30, 2013
• Actual Study Completion Date: Jan 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single Arm	Drug: erlotinib; 150 mg orally once a day for 12 months; Other Names: Tarceva

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Disease Progression or Death at 12 Months After Baseline [12 months]

   According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

2. Progression-Free Survival (PFS) [Up to 1 year after enrollment of the last participant (maximum up to 27 months)]

   PFS was defined as the time from baseline to the date of first occurrence of disease progression or death. According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier method.

3. Probability of Being Progression Free 12 Months After Baseline [12 months]

   According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

Secondary Outcome Measures

1. Percentage of Participants Who Died [Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months)]

2. Overall Survival (OS) [Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months)]

   OS was defined as the time from randomization to the date of death due to any cause. OS was assessed using Kaplan-Meier method.

3. Percentage of Participants With a Response by Best Overall Response [Baseline up to disease progression or end of study (up to 12 Months)]

   Tumor response was assessed according to RECIST v1.1. Complete response (CR): complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. Partial response (PR): greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Stable disease (SD): not qualifying for CR, PR, or PD.

4. Percentage of Participants With Objective Response [Baseline up to disease progression or end of study (up to 12 Months)]

   Objective response was defined as the percentage of participants with CR or PR as best overall response by RECIST v1.1. To be assigned the status of PR or CR, changes in tumor measurements were to be confirmed by repeated assessments no less than 4 weeks after the criteria for response were first met. CR was defined as complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of sum of diameters of all target lesions. The short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. Participants with no tumor assessment after start of study treatment were considered as non-responders. The percentage of participants with response is presented.

5. Percentage of Participants Achieving CR, PR, or SD as Best Overall Response [Baseline up to disease progression or end of study (up to 12 Months)]

   The Disease Control Rate was defined as the percentage of participants who had CR or PR or SD as Best Overall Response achieved within the time between the first drug administration and documented disease progression or end of study. According to RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. SD was defined as not qualifying for CR, PR, or PD.

6. Percentage of Participants With Primary and Secondary Resistance [Baseline up to disease progression (up to 12 Months)]

   Primary resistance: participants did not reach SD or PR or CR before going to PD. Secondary resistance: participants experienced PD after having reached SD or PR or CR at least once. CR: complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

7. Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation by Mutation Type [Baseline, At progression of disease (up to 12 Months)]

   EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR mutation was determined in liquid biopsies by reverse transcriptase-polymerase chain reaction (RT-PCR /Cobas).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Adult patients, >/=18 years of age

• Locally advanced or metastatic non-small cell lung cancer

• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Life expectancy over >/=12 weeks

• Adequate hematological, liver, or kidney function

Exclusion Criteria:

• Previous therapy against epidermal growth factor receptor for metastatic disease

• Treatment with investigational drug during the 3 weeks before enrollment

• History of neoplasm

• Patients with symptomatic cerebral metastases

• Unstable systemic disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A	Napoli	Campania	Italy	80131
2	Ospedale Bellaria; U.O. Oncologia Medica	Bologna	Emilia-Romagna	Italy	40133
3	A.O. Universitaria Policlinico Di Modena; Ematologia	Modena	Emilia-Romagna	Italy	41100
4	Istituto Regina Elena; Oncologia Medica A	Roma	Lazio	Italy	00168
5	Istituto Europeo Di Oncologia	Milano	Lombardia	Italy	20141
6	Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia	Rozzano	Lombardia	Italy	20089
7	Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica	Catania	Sicilia	Italy	95122
8	Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1	Palermo	Sicilia	Italy	90127
9	A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii	Pisa	Toscana	Italy	56124
10	Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica	Perugia	Umbria	Italy	06156

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01378962
• Other Study ID Numbers: ML25514
• First Posted: Jun 23, 2011
• Last Update Posted: Jan 23, 2018
• Last Verified: Dec 1, 2017

• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Erlotinib Hydrochloride

Study Results

Participant Flow

Arm/Group Title	Erlotinib 150 mg
Arm/Group Description	Erlotinib 150 milligrams (mg) tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
Period Title: Overall Study
STARTED	50
COMPLETED	33
NOT COMPLETED	17

Baseline Characteristics

Arm/Group Title	Erlotinib 150 mg
Arm/Group Description	Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
Overall Participants	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.86 (11.42)
Sex: Female, Male (Count of Participants)
Female	34 68%
Male	16 32%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Disease Progression or Death at 12 Months After Baseline
Description	According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) population included all participants enrolled in the study who received at least 1 dose of treatment.

Arm/Group Title	Erlotinib 150 mg
Arm/Group Description	Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
Measure Participants	50
Number [percentage of participants]	42 84%

2. Secondary Outcome

Title	Percentage of Participants Who Died
Time Frame	Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months)

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Erlotinib 150 mg
Arm/Group Description	Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
Measure Participants	50
Number [percentage of participants]	28 56%

3. Secondary Outcome

Title	Overall Survival (OS)
Description	OS was defined as the time from randomization to the date of death due to any cause. OS was assessed using Kaplan-Meier method.
Time Frame	Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months)

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Erlotinib 150 mg
Arm/Group Description	Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
Measure Participants	50
Mean (Standard Error) [months]	17.48 (1.09)

4. Secondary Outcome

Title	Percentage of Participants With a Response by Best Overall Response
Description	Tumor response was assessed according to RECIST v1.1. Complete response (CR): complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. Partial response (PR): greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Stable disease (SD): not qualifying for CR, PR, or PD.
Time Frame	Baseline up to disease progression or end of study (up to 12 Months)

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Erlotinib 150 mg
Arm/Group Description	Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
Measure Participants	50
CR	6 12%
PR	62 124%
SD	12 24%
PD	4 8%
Not estimated	16 32%

5. Secondary Outcome

Title	Percentage of Participants With Objective Response
Description	Objective response was defined as the percentage of participants with CR or PR as best overall response by RECIST v1.1. To be assigned the status of PR or CR, changes in tumor measurements were to be confirmed by repeated assessments no less than 4 weeks after the criteria for response were first met. CR was defined as complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of sum of diameters of all target lesions. The short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. Participants with no tumor assessment after start of study treatment were considered as non-responders. The percentage of participants with response is presented.
Time Frame	Baseline up to disease progression or end of study (up to 12 Months)

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Erlotinib 150 mg
Arm/Group Description	Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	68 136%

6. Primary Outcome

Title	Progression-Free Survival (PFS)
Description	PFS was defined as the time from baseline to the date of first occurrence of disease progression or death. According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier method.
Time Frame	Up to 1 year after enrollment of the last participant (maximum up to 27 months)

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Erlotinib 150 mg
Arm/Group Description	Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
Measure Participants	50
Median (90% Confidence Interval) [months]	12.58

7. Primary Outcome

Title	Probability of Being Progression Free 12 Months After Baseline
Description	According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Erlotinib 150 mg
Arm/Group Description	Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
Measure Participants	50
Mean (Standard Error) [probability of being progression-free]	0.51 (0.08)

8. Secondary Outcome

Title	Percentage of Participants Achieving CR, PR, or SD as Best Overall Response
Description	The Disease Control Rate was defined as the percentage of participants who had CR or PR or SD as Best Overall Response achieved within the time between the first drug administration and documented disease progression or end of study. According to RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. SD was defined as not qualifying for CR, PR, or PD.
Time Frame	Baseline up to disease progression or end of study (up to 12 Months)

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	Erlotinib 150 mg
Arm/Group Description	Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	80 160%

9. Secondary Outcome

Title	Percentage of Participants With Primary and Secondary Resistance
Description	Primary resistance: participants did not reach SD or PR or CR before going to PD. Secondary resistance: participants experienced PD after having reached SD or PR or CR at least once. CR: complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: >=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame	Baseline up to disease progression (up to 12 Months)

Outcome Measure Data

Analysis Population Description

Analysis population included all participants enrolled in the study who received at least 1 dose of treatment and who had a documented PD response during the study period.

Arm/Group Title	Erlotinib 150 mg
Arm/Group Description	Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
Measure Participants	24
Primary resistance	8.33 16.7%
Secondary resistance	91.67 183.3%

10. Secondary Outcome

Title	Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation by Mutation Type
Description	EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR mutation was determined in liquid biopsies by reverse transcriptase-polymerase chain reaction (RT-PCR /Cobas).
Time Frame	Baseline, At progression of disease (up to 12 Months)

Outcome Measure Data

Analysis Population Description

Analysis population included all participants enrolled in the study who received at least 1 dose of treatment and who had samples for EGFR mutation. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.

Arm/Group Title	Erlotinib 150 mg
Arm/Group Description	Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
Measure Participants	45
Baseline: EGFR18 Mutation (n=45)	0.00 0%
Baseline: EGFR19 Codon Deletion Mutation (n=45)	51.11 102.2%
Baseline: EGFR20 Codon T790M Mutation (n=45)	2.22 4.4%
Baseline: EGFR21 Codon L585R Mutation (n=45)	15.56 31.1%
At PD: EGFR18 Mutation (n=18)	0.00 0%
At PD: EGFR19 Codon Deletion Mutation (n=18)	50.00 100%
At PD: EGFR20 Codon T790M Mutation (n=18)	27.78 55.6%
At PD: EGFR21 Codon L585R Mutation (n=18)	16.67 33.3%

Adverse Events

Time Frame	Up to 1 year after enrollment of the last participant (maximum up to 27 months)
Adverse Event Reporting Description	Safety population included all participants enrolled in the study who received at least one dose of treatment and had at least one safety assessment.
Arm/Group Title	Erlotinib 150 mg
Arm/Group Description	Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
All Cause Mortality
	Erlotinib 150 mg
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Erlotinib 150 mg
	Affected / at Risk (%)	# Events
Total	10/50 (20%)
Cardiac disorders
Cardiac failure acute	1/50 (2%)
Gastrointestinal disorders
Dysphagia	1/50 (2%)
General disorders
Chest pain	1/50 (2%)
Infections and infestations
Pneumonia	2/50 (4%)
Injury, poisoning and procedural complications
Hip fracture	1/50 (2%)
Metabolism and nutrition disorders
Decreased appetite	1/50 (2%)
Nervous system disorders
Convulsion	1/50 (2%)
Hemiplegia	1/50 (2%)
Psychiatric disorders
Confusional state	1/50 (2%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	2/50 (4%)
Pneumothorax	1/50 (2%)
Vascular disorders
Jugular vein thrombosis	1/50 (2%)
Other (Not Including Serious) Adverse Events
	Erlotinib 150 mg
	Affected / at Risk (%)	# Events
Total	46/50 (92%)
Ear and labyrinth disorders
Vertigo	4/50 (8%)
Eye disorders
Conjunctivitis	11/50 (22%)
Gastrointestinal disorders
Abdominal pain upper	4/50 (8%)
Diarrhoea	27/50 (54%)
Stomatitis	4/50 (8%)
Vomiting	4/50 (8%)
Nausea	3/50 (6%)
General disorders
Asthenia	9/50 (18%)
Chest pain	7/50 (14%)
Fatigue	5/50 (10%)
Pyrexia	9/50 (18%)
Oedema peripheral	3/50 (6%)
Infections and infestations
Paronychia	7/50 (14%)
Cystitis	3/50 (6%)
Injury, poisoning and procedural complications
Contrast media reaction	3/50 (6%)
Investigations
Blood bilirubin increased	3/50 (6%)
Metabolism and nutrition disorders
Decreased appetite	6/50 (12%)
Musculoskeletal and connective tissue disorders
Back pain	4/50 (8%)
Muscle spasms	4/50 (8%)
Musculoskeletal pain	3/50 (6%)
Respiratory, thoracic and mediastinal disorders
Cough	10/50 (20%)
Epistaxis	4/50 (8%)
Haemoptysis	3/50 (6%)
Skin and subcutaneous tissue disorders
Alopecia	7/50 (14%)
Dermatitis acneiform	5/50 (10%)
Dry skin	4/50 (8%)
Pruritus	10/50 (20%)
Rash	36/50 (72%)
Skin ulcer	4/50 (8%)
Nail disorder	3/50 (6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.