SWOG clinical trial number
S1400I

A BIOMARKER-DRIVEN MASTER PROTOCOL FOR PREVIOUSLY TREATED SQUAMOUS CELL LUNG CANCER - A PHASE III RANDOMIZED STUDY OF NIVOLUMAB PLUS IPILIMUMAB VERSUS NIVOLUMAB FOR PREVIOUSLY TREATED PATIENTS WITH STAGE IV SQUAMOUS CELL LUNG CANCER AND NO MATCHING BIOMARKER

Closed
Phase
Accrual
79%
Abbreviated Title
Lung-MAP S1400I: Non-Match, Nivolumab + Ipilimumab
Status Notes
Effective 3:00 p.m. Pacific Time on April 23, 2018, S1400I will be permanently closed to accrual.

This is a potential FDA registration study. There will be additional centralized and on-site monitoring conducted in addition to routine audits. Sites must also maintain a study specific Trial Master File for this study (https://swog.org/Visitors/QA/Index.asp).
Activated
12/18/2015
Closed
04/23/2018
Participants
NCORP, Members, Medical Oncologists, Pathologists, CTSU, Affiliates, CCTG

Research committees

Lung Cancer

Treatment

Ipilimumab Nivolumab

Other Study Materials

Eligibility Criteria Expand/Collapse

(In addition to S1400 Lung-MAP criteria)

5.1 Sub-Study Specific Disease Related Criteria

a. Patients must have been assigned to S1400I.

b. 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.

c. 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

a. Patients must not have any known allergy or reaction to any component of the nivolumab and ipilimumab formulations.

b. 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.

c. 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.]

d. 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.]

e. 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.

f. Patients must also be offered participation in banking for future use of specimens as described in Section 15.0.

g. 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.]

h. 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.

i. 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.

Publication Information Expand/Collapse

2022

Dynamic changes in circulating protein levels reveal an association between ipilimumab and nivolumab combination treatment (SWOG Lung-MAP S1400I trial) with outcomes in squamous cell lung cancer

E Gonzalez-Kozlova;H-H Huang;M Redman;R Herbst;S Gettinger;L Bazhenova;H Xie;M Patel;K Nie;J Harris;K Argueta;D Del Valle;S Kim-Schulze;S Gnjatic American Association for Cancer Research (April 8 - 13, 2022 New Orleans, LA), poster

Infiltration and spatial distribution of immune cells are associated clinical benefit from Nivolumab/Ipilimumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer: an immune biomarker analysis of Phase III SWOG Lung-MAP S1400I trial

E Parra;J Zhang;M Redman;R Lazcano;M Piubelli;C Laberiano Fernandez;R Pandurengan;S Zhang;H Chen;G Manyam;D Duose;J Zhang;G Al-Atrash;R Herbst;K Kannan;E Gonzalez-Kozlova;S Gnjatic;I Wistuba;S Gettinger;L Bazhenova;J Lee;J Zhang;C Haymaker American Association for Cancer Research (April 8 - 13, 2022 New Orleans, LA), poster

Immune Gene Expression Signatures associated clinical benefit from Nivolumab/Ipilimumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer: an immune biomarker analysis of Phase III SWOG Lung-MAP S1400I trial

D Duose;J Zhang;M Redman;B Zhang;R Luthra;G Al-Atrash;R Herbst;E Gonzalez-Kozlova;S Gnjatic;I Wistuba;S Gettinger;L Bazhenova;J Lee;J Zhang American Association for Cancer Research (April 8 - 13, 2022 New Orleans, LA), poster

Multi-omics profiling reveals molecular and immune features associated with benefit from immunotherapy for Previously Treated Stage IV or recurrent Squamous Cell Lung Cancer patients from the Phase III SWOG LungMAP S1400I trial

E Parra;D Duose;J Zhang;M Redman;R Lazcano;M Piubelli;C Laberiana Fernandez;B Zhang;E Cerami;J Lindsay;J Yu;R Biswas;S Van Nostrand;R Moravec;K Kannan;R Luthra;G Al-Atrash;K Kelly;R Herbst;I Wistuba;S Gettinger;L Bazhenova;J Lee;J Zhang;J Zhang;C Haymaker J Clin Oncol 40, 2022 (suppl 16; abstr 9046), poster 34; ASCO Annual Meeting (June 3-7, 2022, Chicago, IL)

Dynamic changes in serum analyte levels associated with clinical outcome in squamous cell lung cancer trial SWOG Lung-MAP S1400I of nivolumab ± ipilimumab

E Gonzalez-Kozlova;H-H Huang;M Redman;R Herbst;S Gettinger;L Bazhenova;H Xie;M Patel;K Nie;J Harris;C Argueta;K Kelly;E Cerami;R Biswas;S Van Nostrand;R Moravic;D Del Valle;S Kim-Schulze;S Gnjatic J Clin Oncol 40, 2022 (suppl 16; abstr 9044), poster 32; ASCO Annual Meeting (June 3-7, 2022, Chicago, IL)

Nivolumab Plus Ipilimumab for Previously Treated Stage IV Squamous Cell Lung Cancer-Reply

S Gettinger;M Redman;R Herbst JAMA Oncology Feb 10. doi: 10.1001/jamaoncol.2021.7790. Online ahead of print

PMid: PMID35142793

2021

A phase III study of nivolumab plus ipilimumab versus nivolumab for previously treated patients with stage IV squamous cell lung cancer (Lung-MAP Sub-Study S1400I, NCT02785952)

S Gettinger;M Redman;L Bazhenova;F Hirsch;P Mack;L Schwartz;D Gandara;J Bradley;T Stinchcombe;N Leighl;S Ramalingam;S Tavernier;J Unger;K Minichiello;K Kelly;V Papadimitrakopoulou;RS Herbst JAMA Oncology Sep 1;7(9):1368-1377; Jul 15;e212209. doi: 10.1001/jamaoncol.2021.2209. Online ahead of print

PMid: PMID34264316 | PMC number: PMC8283667

Tumor Mutation Burden (TMB) by Next Generation Sequencing (NGS) associates with Survival (OS) in Lung-MAP Immunotherapy Trials S1400I and S1400A

FR Hirsch;X Hua;M Wu;J Neal;H Cheng;S Gettinger;L Bazhenova;V Papadimitrakopoulou;H Borghaei;P Mack;K Kelly;RS Herbst;D Gandara;MW Redman;D Kozono WCLC World Conference on Lung Cancer (January 28-31, 2021, virtual), oral, #OA01.04

2019

A phase III randomized study of nivolumab plus ipilimumab versus nivolumab for previously treated patients with stage IV squamous cell lung cancer and no matching biomarker (Lung-MAP Sub-Study S1400I, NCT02785952).

L Bazhenova;M Redman;S Gettinger;F Hirsch;PC Mack;L Schwartz;D Gandara;J Bradley;T Stinchcombe;N Leighl;S Ramalingam;S Tavernier;K Minichiello;K Kelly;V Papadimitrakopoulou;R Herbst J Clin Oncol 37(suppl; abstr 9014); ASCO (5/31/19-6/4/19, Chicago IL), poster discussion

A Phase III Randomized Study of Nivolumab/Ipilimumab vs Nivolumab for Previously Treated Stage IV Squamous Lung Cancer

L Bazhenova;M Redman;S Gettinger;F Hirsch;P Mack;L Schwartz;D Gandara;JD Bradley;T Stinchcombe;N Leighl;S Ramalingam;S Tavernier;K Minichiello;K Kelly;V Papadimitrakopoulou;RS Herbst WCLC IASCLC Annual Meeting (September 7-10, 2019, Barcelona, Spain), oral

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