A Study of Neoadjuvant Atezolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (IMpower030)

NCT03456063 PHASE3 COMPLETED

This is a randomized, double-blinded study designed to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in participants with resectable Stage II, IIIA, or select IIIB non-small cell lung cancer (NSCLC) followed by open-label adjuvant/postoperative atezolizumab or best supportive care and monitoring.

Details

Lead sponsor	Hoffmann-La Roche
Phase	PHASE3
Status	COMPLETED
Enrolment	453
Start date	Tue Apr 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Dec 31 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Non-Small-Cell Lung

Interventions

• Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
• Placebo Comparator
• Nab-paclitaxel
• Pemetrexed
• Carboplatin
• Cisplatin
• Gemcitabine

Countries

Italy, Japan, Taiwan, Poland, South Korea, Russia, Sweden, Thailand, United States, France, South Africa, Serbia, Austria, Israel, Hungary, Spain, Brazil, Ukraine, United Kingdom, Germany, Slovenia, Australia, Switzerland, China