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

Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Study ID
NCT03469960
Phase
PHASE3
Status
Completed

Conditions

  • Non-Small Cell Lung Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    Ipilimumab 1 mg/kg every 6 weeks
  • Nivolumab — DRUG
    Nivolumab 3 mg/kg every 2 weeks

Study Details

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.

Key Dates

Start date
May 2, 2018
Status verified
Nov 2025
Primary completion
Nov 8, 2023
Completion
Oct 15, 2025

Study Design

Enrollment
265 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A : standard treatment
    6 months of treatment by nivolumab + ipilimumab then nivolumab + ipilimumab then in case of progression platinum-based doublet recommended
  • Experimental: Arm B : experimental arm
    6 months of treatment by nivolumab + ipilimumab then observation the in case of progression nivolumab + ipilimumab then in case of progression platinum-based doublet recommended

Primary Outcome Measure

Progression Free Survival (PFS1) [ Time Frame: 24 months after randomization of the last subject ]

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