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Protocol No. S1400

Principal Investigator Traynor, Anne

Phase II/III

Age Group Adult

Scope National

Sponsor Type National

Title Phase II/III Biomarker-Driven Master Protocol for Second Line Therapy of Squamous Cell Lung Cancer

Objective There are several investigational treatments that are being tested in various sub-studies as part of this study. For this sub-study, you will be assigned to treatment with either nivolumab (the current standard of care) or to nivolumab combined with ipilimumab (the investigational therapy). The purpose of this sub-study is to learn if the study drug will improve the average time to cancer worsening by more than a month. Nivolumab combined with ipilimumab is investigational for this study.

Treatment Nivolumab, an immunotherapy drug was recently FDA approved for patients with squamous lung cancer who previously received chemotherapy. Nivolumab (the investigational therapy) combined with ipilimumab is investigational for this study. More information can be found at

Description This sub-study has two study groups (arms). A computer will by chance assign you to a treatment arm in the study. This is called randomization. Patients assigned to Arm 1 will receive the study drug nivolumab combined with ipilimumab and nivolumab will be given via vein over 30 minutes on Day 1 of every 14 day cycle. Ipilimumab will be given via vein over 60 minutes on Day 1 of every third cycle. A cycle is 14 days. Patients assigned to Arm 2 will receive the study drug nivolumab alone, one of the standard treatments for this cancer. Nivolumab will be given via vein over 30 minutes on Day 1 of every 14 day cycle. A cycle is 14 days. Click here for more info

Key Eligibility
  • Patients must have pathologically proven squamous cell carcinoma (SCCA) cancer of the lung. Disease must be Stage IV SCCA or recurrent
  • Screening at progression on prior treatment: To be eligible for screening at progression, patients must have received at least one line of systemic therapy for any stage of disease (Stages I-IV). At least one of these lines of therapy must have been a platinum-based chemotherapy regimen
  • Pre-Screening prior to progression on current treatment: To be eligible for pre-screening, current treatment must be for Stage IV or recurrent disease and patient must have received at least one dose of the current regimen. Patients must have previously received or currently be receiving a platinum-based chemotherapy regime
  • Patients must not have a known EGFR mutation, or ALK fusion
  • Patients must be willing to provide prior smoking history
  • Patients must not be pregnant or nursing
  • Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection

Applicable Disease Sites Lung

Status Open

Participating Institutions Aspirus UW Cancer Center (formerly Riverview Hospital); Aspirus Wausau Hospital, Aspirus Regional Cancer Center; Johnson Creek, UW Cancer Center; Langlade Memorial Hospital, Aspirus Regional Cancer Ctr; Mercy Health Systems, Janesville ; UW Hospital and Clinics; UWCCC 1 South Park