Immunotherapy as Second-line in Patient With Small Cell Lung Cancer

Sponsor
Intergroupe Francophone de Cancerologie Thoracique
Study ID
NCT03059667
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Atezolizumab at 1200 mg IV every 3 weeks
  • Topotecan — DRUG
    oral 2.3 mg/m² or IV 1.5 mg/m² day 1-4 recommended
  • Carboplatin — DRUG
    In accordance with the summary of product characteristics.
  • Etoposide — DRUG
    In accordance with the summary of product characteristics.

Study Details

Chemotherapy still constitutes the backbone of small-cell lung cancer (SCLC) therapy, particularly in the extensive disease (ED) stage (ED-SCLC). Despite the fact that a substantial complete response rate could be achieved in SCLC patients receiving etoposide - cisplatin doublet, cure remains the exception. Overall survival in patients receiving this combination is 10 months and progression free survival 6.3 months. At time of progression two options are hitherto accepted: reinduction of carboplatin - etoposide doublet or, for patients unfit for reinduction, topotecan single-drug regimen. However, in both clinical cases, median survival hardly achieves 33 weeks. Consistent data using anti - PDL1 (Programmed death-ligand 1) or anti PD1 (programmed cell death 1) antibodies suggest that they are active as single drug regimens in many malignant diseases. Taking into account the rich tumor infiltrating lymphocyte in pathological specimens of SCLC, we can hypothesize that experimental use of ATEZOLIZUMAB (MPDL3280A) in patients is ethical pending that it demonstrates activity in the second line setting.

Key Dates

Start date
Mar 13, 2017
Status verified
Feb 2021
Primary completion
Sep 10, 2018
Completion
Dec 1, 2020

Study Design

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

Arms

  • Active Comparator: Arm A : chemotherapy
    Patients randomly assigned to the control arm will receive either: * topotecan (oral 2.3 mg/m² or IV 1.5 mg/m² day 1-4 recommended) * or re-induction by carboplatin - etoposide chemotherapy.
  • Experimental: Arm B : immune therapy
    Patients randomly assigned to the experimental arm will receive Anti PDL1 ATEZOLIZUMAB (MPDL3280A) at a fixed dose of 1200 mg IV every three weeks until progression or unacceptable toxicity.

Primary Outcome Measure

Response Rate in the experimental arm [ Time Frame: 6 weeks ]

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