drugset / Trial / NCT03059667

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

NCT03059667

Phase 2 Completed 73 enrolled French Cooperative Thoracic Intergroup
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2017-03-13
Primary completion
2018-09-10
Completion
2020-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Comparator Carboplatin Small molecule
Comparator Etoposide Small molecule
Comparator Topotecan Small molecule 1.5 mg/m2 Oral
Comparator Topotecan Small molecule 2.3 mg/m2 Oral