S1400I Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers

Official Title

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)

Summary:

This randomized phase III trial compares nivolumab with ipilimumab and nivolumab alone in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a "non-match" sub-study that includes all screened patients not eligible for a biomarker-driven sub-study. Monoclonal antibodies, such as nivolumab and ipilimumab, may be able to shrink tumours. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with squamous cell lung cancer.

Trial Description

Primary Outcome:

  • IA-PFS as defined by RECIST 1.1 (Design #1, Phase II)
  • Less than 33% improvement in median IA-PFS as defined as RECIST 1.1 (Design #1, Phase III)
  • OS (Design #1, Phase III)
  • Overall survival
Secondary Outcome:
  • IA-PFS, censoring patients with symptomatic deterioration (SD) at the time of SD (Design #1, Phase III)
  • Response rate (confirmed and unconfirmed) in patients with measurable disease as defined by RECIST 1.1 (Design #1, Phase II and III)
  • Toxicity frequencies, monitored using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Design #1, Phase II and III)
PRIMARY OBJECTIVES:
  • To compare overall survival (OS) in patients with advanced stage refractory squamous cell carcinoma (SCCA) of the lung randomized to nivolumab plus ipilimumab versus nivolumab.
SECONDARY OBJECTIVES:
  • To compare investigator-assessed progression-free survival (IA-PFS) in patients with advanced stage refractory SCCA of the lung randomized to nivolumab plus ipilimumab versus nivolumab.
  • To compare the response rates (confirmed and unconfirmed, complete and partial) per Response Evaluation Criteria In Solid Tumours (RECIST) 1.1 among patients randomized to receive nivolumab plus ipilimumab versus nivolumab.
  • To compare the response rates (confirmed only, complete and partial) per RECIST 1.1 among patients randomized to receive nivolumab plus ipilimumab versus nivolumab.
  • To evaluate the frequency and severity of toxicities associated with nivolumab plus ipilimumab versus nivolumab.
TRANSLATIONAL MEDICINE OBJECTIVES:
  • To evaluate if there is a differential treatment effect on OS, IA-PFS, and response by tumour programmed death-ligand 1 (PD-L1) expression status.
OUTLINE:
Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up until death or 3 years after sub-study registration, whichever occurs first.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society