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Brief Title: Immunotherapy as Second-line in Patient With Small Cell Lung Cancer
Official Title: 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)
Study ID: NCT03059667
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Annemasse - CH, Ambilly, , France
Angers - CHU, Angers, , France
CH, Colmar, , France
CHRU Grenoble, Grenoble, , France
Centre Hospitalier - Pneumologie, Le Mans, , France
Lorient - CHBS, Lorient, , France
Montpellier - CHRU, Montpellier, , France
Mulhouse - CH, Mulhouse, , France
Centre Antoine Lacassagne, Nice, , France
AP-HP Hopital Tenon - Pneumologie, Paris, , France
APHP - Paris Bichat, Paris, , France
GH Paris Saint-Joseph, Paris, , France
CHG de Pau, Pau, , France
HCL - Lyon Sud (Pneumologie), Pierre Bénite, , France
Rouen - CHU, Rouen, , France
Centre Hospitalier, Saint-Quentin, , France
Toulouse - CHU Larrey, Toulouse, , France
CHU Tours - Pneumologie, Tours, , France
Name: Jean-Louis PUJOL, MD PhD
Affiliation: CHU de Montpellier
Role: PRINCIPAL_INVESTIGATOR