At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed small cell lung cancer from tissue sampling (not sputum alone)
- ✓Extensive-stage disease at initial diagnosis
- ✓ECOG performance status 0 or 1
- ✓Completed 4–6 cycles of platinum-based first-line chemotherapy (cisplatin or carboplatin with etoposide or irinotecan) with ongoing CR, PR, or SD; or 3 cycles if toxicity-limited with PR or CR
- ✕Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies
- ✕Active, known, or suspected autoimmune disease (with exceptions for type 1 diabetes on replacement, hypothyroidism on replacement, or skin conditions not requiring systemic treatment)
- ✕Systemic corticosteroids >10 mg daily prednisone equivalent or other immunosuppressive medications within 14 days of randomization
- ✕Symptomatic interstitial lung disease or disease that may interfere with detection/management of drug-related pulmonary toxicity
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Consolidative Ipilimumab and Nivolumab With Thoracic Radiotherapy After Platinum Based Chemotherapy for Patients With Extensive-Stage Small Cell Lung Cancer
In Brief
A Phase 2 clinical trial evaluating Thoracic Radiation Therapy, Ipilimumab, and 1 other intervention for Small Cell Lung Cancer and Extensive-stage Small Cell Lung Cancer. Completed, enrolled 21 participants across 1 site.
Detailed Summary
The purpose of the safety run in Phase I portion of this study is to confirm the recommended Phase II dose of ipilimumab and nivolumab among participants treated with combined thoracic radiation therapy (30 Gy in 10 fractions) and nivolumab/ipilimumab following standard treatment with 4-6 cycles of platinum-based chemotherapy. The purpose of the Phase II portion of this study is to estimate the 6-month Progression Free Survival (PFS) rate among participants treated with ipilimumab and nivolumab with thoracic radiation therapy (30 Gy in 10 fractions) after standard treatment with 4 to 6 cycles of platinum based chemotherapy.
Study Details
Timeline
Interventions
All participants will receive radiation therapy (3Gy x 10 fractions) to the chest for 10 days (Monday through Friday for 2 weeks).
Ipilimumab 3 mg/kg (90 minute IV infusion) will be administered every 3 weeks for 4 doses.
Nivolumab 1 mg/kg (30 minute IV infusion) will be administered every 3 weeks for 4 doses, followed by nivolumab 480 mg every 4 weeks.