Nivolumab +/- Ipilimumab for Lung Cancer

Recruiting at 1206 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: SWOG Cancer Research Network

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Autoimmune disease, Hepatitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 3

Duration: Up to 3 years

275 Participants Needed

Trial Summary

What is the purpose of this trial?

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 tumors. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with squamous cell lung cancer.

Research Team

Vassiliki Papadimitrakopoulou

Principal Investigator

SWOG Cancer Research Network

Eligibility Criteria

This trial is for patients with stage IV squamous cell lung cancer that has returned after treatment. Participants must not have allergies to nivolumab or ipilimumab, no recent steroids or immunosuppressants, no HIV/AIDS, and should be free of certain heart conditions. They can't have had prior treatments targeting immune checkpoints and must not suffer from active autoimmune diseases.

Inclusion Criteria

I do not have lung disease that causes symptoms or could affect lung toxicity treatment.

Patients who can complete Patient Reported Outcomes (PRO) forms in English are required to complete a pre-study S1400I Patient Reported Outcomes (PRO) Questionnaire and a pre-study S1400I European Quality of Life Five Dimension (EQ-5D) Questionnaire within 14 days prior to registration; NOTE: Patients enrolled to S1400I prior to 9/1/2016 are not eligible for the PRO study

I have not received treatments targeting immune checkpoints.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive nivolumab with or without ipilimumab intravenously. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Up to 3 years

Bi-weekly visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment. Follow-up occurs every 3 months for 1 year, then every 6 months for up to 3 years.

Up to 3 years

Every 3 months for 1 year, then every 6 months

Treatment Details

Interventions

• Ipilimumab
• Nivolumab

Trial Overview The study compares the effectiveness of two monoclonal antibodies: nivolumab alone versus nivolumab combined with ipilimumab in treating recurrent lung cancer. It's a phase III trial for those who didn't qualify for other biomarker-driven studies.

Participant Groups

Group I: Arm I (nivolumab, ipilimumab) Experimental Treatment 5 Interventions

Patients receive nivolumab 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.

Group II: Arm II (nivolumab) Active Control 4 Interventions

Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Ipilimumab is already approved in United States, European Union for the following indications:

Approved in United States as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Approved in European Union as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Who Is Running the Clinical Trial?

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+