NCT03469960

Double Immune Checkpoint Inhibitors in PD-L1-positive Stage IV Non-small Lung CancEr

A Randomized Phase 3 Trial Comparing Continuation Nivolumab-Ipilimumab Doublet Immunotherapy Until Progression Versus Observation in Treatment-naive Patients With PDL1-positive Stage IV Non-Small Cell Lung Cancer (NSCLC) After Nivolumab-Ipilimumab Induction Treatment

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Intergroupe Francophone de Cancerologie Thoracique · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Non Small Cell lung cancer (NSCLC) remains the first cause of death by cancer in the World. For the patients presenting a NSCLC stage IV, the median of survival is about 15 months today. The chemotherapy with platinum is the standard treatment for these patients but immunotherapy showed these efficacy in 1st line for patients PD-L1 positive. On the other hand, the duration of treatment by immunotherapy is not clear. Indeed, prolonged responses and long survivals have been described in patients having interrupted the treatment. In the melanoma, a treatment of 6 months of ipilimumab demonstrated its efficacy. The objective of the study is to demonstrate that a treatment of 6 months followed by an observation (stop and go) is not less effective than a treatment given until progression or toxicity. This strategy would allow to decrease the accumulated toxicities, to improve the quality of life of the patients and to decrease the costs.

Conditions

• Non-Small Cell Lung Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Ipilimumab	Ipilimumab 1 mg/kg every 6 weeks
DRUG	Nivolumab	Nivolumab 3 mg/kg every 2 weeks

Timeline

• Start date: 2018-05-02
• Primary completion: 2023-11-08
• Completion: 2025-10-15
• First posted: 2018-03-19
• Last updated: 2025-11-18

Locations

47 sites across 1 country: France