Clinical Trials Directory

Trials / Completed

CompletedNCT03059667

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

A Randomized Non-comparative Phase II Study of Anti-PDL1 ATEZOLIZUMAB (MPDL3280A) or Chemotherapy as Second-line Therapy in Patients With Small Cell Lung Cancer (SCLC)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
73 (actual)
Sponsor
Intergroupe Francophone de Cancerologie Thoracique · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGAtezolizumabAtezolizumab at 1200 mg IV every 3 weeks
DRUGTopotecanoral 2.3 mg/m² or IV 1.5 mg/m² day 1-4 recommended
DRUGCarboplatinIn accordance with the summary of product characteristics.
DRUGEtoposideIn accordance with the summary of product characteristics.

Timeline

Start date
2017-03-13
Primary completion
2018-09-10
Completion
2020-12-01
First posted
2017-02-23
Last updated
2021-02-10

Locations

18 sites across 1 country: France

Source: ClinicalTrials.gov record NCT03059667. Inclusion in this directory is not an endorsement.