Lung-MAP S1400K: c-MET Positive

Brief Summary
S1400K of Lung-MAP seeks to evaluate the overall response rate with ABBV-399 (Process II) in patients with c-MET positive SCCA.

S1400K is a biomarker-driven study for patients with Stage IV or recurrent squamous cell lung cancer, who have c-MET positive squamous cell tumors.
Brief Title
Lung-MAP S1400K: c-MET Positive
Completion Date
Completion Date Type
Actual
Conditions
Recurrent Squamous Cell Lung Carcinoma
Stage IV Squamous Cell Lung Carcinoma AJCC V7
Eligibility Criteria
•Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER 5.1 Sub-Study Specific Disease Related Criteria

1. Patients must have been assigned to S1400I.
2. Patients must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
3. Patients must not have an active, known, or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.

5.2 Sub-Study Specific Clinical/Laboratory Criteria

1. Patients must not have any known allergy or reaction to any component of the nivolumab and ipilimumab formulations.
2. Patients must not have received systemic treatment with corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to sub-study registration. Inhaled or topical steroids, and adrenal replacement doses \<= 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.
3. Patients must not have a known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. Patients with a positive hepatitis C antibody with a negative viral load are allowed. \[This criterion replaces common eligibility criteria in Section 5.3m.\]
4. Patients must not have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). \[This criterion replaces common eligibility criteria in Section 5.3n.\]
5. Patients must not have interstitial lung disease that is symptomatic or disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity.
6. Patients must also be offered participation in banking for future use of specimens as described in Section 15.0.
7. Patients must have a Lipase, Amylase, TSH with reflex Free T3/T4 performed within 7 days prior to sub-study registration. Additional timepoints are noted in Section 9.0, Study Calendar. \[Note: For the Canadian sites, testing for lipase only is acceptable.\]
8. Patients must not have any Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia (see Section 18.1b).

1. Patients with a history of congestive heart failure (CHF) or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drug should have an EKG and echocardiogram performed to evaluate cardiac function as clinically indicated.
2. Patients with evidence of congestive heart failure (CHF), myocardial infarction (MI), cardiomyopathy, or myositis should have a cardiac evaluation including lab tests and cardiology consultations as clinically indicated including EKG, CPK, troponin, and echocardiogram.
9. Patients who can complete PRO forms in English are required to complete a pre-study S1400I Patient Reported Outcomes (PRO) Questionnaire and a pre-study S1400I EQ-5D Questionnaire within 14 days prior to registration (see Section 18.2 of S1400I). NOTE: Patients enrolled to S1400I prior to 9/1/2016 are not eligible for the PRO study.
Inclusion Criteria
•Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER 5.1 Sub-Study Specific Disease Related Criteria

1. Patients must have been assigned to S1400I.
2. Patients must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
3. Patients must not have an active, known, or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.

5.2 Sub-Study Specific Clinical/Laboratory Criteria

1. Patients must not have any known allergy or reaction to any component of the nivolumab and ipilimumab formulations.
2. Patients must not have received systemic treatment with corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to sub-study registration. Inhaled or topical steroids, and adrenal replacement doses \<= 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease.
3. Patients must not have a known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. Patients with a positive hepatitis C antibody with a negative viral load are allowed. \[This criterion replaces common eligibility criteria in Section 5.3m.\]
4. Patients must not have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). \[This criterion replaces common eligibility criteria in Section 5.3n.\]
5. Patients must not have interstitial lung disease that is symptomatic or disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity.
6. Patients must also be offered participation in banking for future use of specimens as described in Section 15.0.
7. Patients must have a Lipase, Amylase, TSH with reflex Free T3/T4 performed within 7 days prior to sub-study registration. Additional timepoints are noted in Section 9.0, Study Calendar. \[Note: For the Canadian sites, testing for lipase only is acceptable.\]
8. Patients must not have any Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia (see Section 18.1b).

1. Patients with a history of congestive heart failure (CHF) or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drug should have an EKG and echocardiogram performed to evaluate cardiac function as clinically indicated.
2. Patients with evidence of congestive heart failure (CHF), myocardial infarction (MI), cardiomyopathy, or myositis should have a cardiac evaluation including lab tests and cardiology consultations as clinically indicated including EKG, CPK, troponin, and echocardiogram.
9. Patients who can complete PRO forms in English are required to complete a pre-study S1400I Patient Reported Outcomes (PRO) Questionnaire and a pre-study S1400I EQ-5D Questionnaire within 14 days prior to registration (see Section 18.2 of S1400I). NOTE: Patients enrolled to S1400I prior to 9/1/2016 are not eligible for the PRO study.
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03574753
Org Class
Network
Org Full Name
SWOG Cancer Research Network
Org Study Id
S1400K
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase II Study of ABBV-399 in Patients With C-Met Positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP SUB-STUDY)
Primary Outcomes
Outcome Description
The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with ABBV-399 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).
Outcome Measure
Overall Response Rate in Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA)
Outcome Time Frame
11 months
Secondary Outcomes
Outcome Description
Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration or death due to any cause.
Outcome Time Frame
up to 3 years post sub-study registration
Outcome Measure
Investigator-assessed Progression-free Survival) in Immunotherapy-exposed and Relapsed Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA).
Outcome Description
Duration from date of sub-study registration (or date of screening/pre-screening registration if patient never enrolls in a sub-study) to date of death due to any cause
Outcome Time Frame
up to 3 years post sub-study registration
Outcome Measure
Overall Survival (OS) in Immunotherapy-exposed and Relapsed Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA).
Outcome Description
The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with ABBV-399 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1).
Outcome Time Frame
Up to 3 years
Outcome Measure
Overall Response Rate (ORR) in Immunotherapy-exposed and Relapsed Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA).
Outcome Description
Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration or death due to any cause
Outcome Time Frame
Up to 3 years post sub-study registration
Outcome Measure
Investigator-assessed Progression-free Survival (IA-PFS) in Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA)
Outcome Description
Duration from date of sub-study registration (or date of screening/pre-screening registration if patient never enrolls in a sub-study) to date of death due to any cause.
Outcome Time Frame
Up to 3 years post sub-study registration
Outcome Measure
Overall Survival (OS) in Participants With c-Met Positive Lung Squamous Cell Carcinoma (SCCA)
Outcome Description
Duration from date of first documentation of response (complete or partial) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause among participants who achieve a complete or partial response.
Outcome Time Frame
Up to 3 years post sub-study registration
Outcome Measure
Duration of Response (DoR)
Outcome Description
Adverse Events (AEs) are reported by CTCAE Version 5.0 for serious adverse events only and CTCAE Version 4.0 for routine toxicity reporting. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Outcome Time Frame
Duration of treatment and follow up until death or 3 years post sub-registration
Outcome Measure
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Start Date
Start Date Type
Actual
Status Verified Date
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Haiying Cheng
Investigator Email
HCHENG@montefiore.org
Investigator Phone
718-405-8404