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)

Conditions

• Non-Small-Cell Lung

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody — DRUG
  Atezolizumab will be administered as intravenous (IV) infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle (every 3 weeks) for 4 cycles during the neoadjuvant treatment phase Atezolizumab will be administered as IV infusion at a dose of 1200 milligrams (mg) every 3 weeks for 16 cycles during the post-operative adjuvant phase
• Placebo Comparator — DRUG
  Placebo will be administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
• Nab-paclitaxel — DRUG
  Nab-paclitaxel 100 mg/m\^2 will be administered intravenously on Days 1, 8, and 15 of each 21 day cycle for 4 cycles during the neoadjuvant treatment phase
• Pemetrexed — DRUG
  Pemetrexed 500 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
• Carboplatin — DRUG
  Carboplatin initial target AUC of 6 mg/mL/min will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
• Cisplatin — DRUG
  Cisplatin 75 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
• Gemcitabine — DRUG
  Gemcitabine 1250 mg/m\^2 will be administered intravenously on Day 1 and 8 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase

Study Details

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.

Key Dates

Start date

Apr 24, 2018

Status verified

Jan 2026

Primary completion

Oct 1, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

453 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Atezolizumab + platinum-based chemotherapy
  Neoadjuvant treatment will consist of 4 cycles; atezolizumab + platinum-based chemotherapy Platinum-based chemotherapy may include: * carboplatin + pemetrexed * carboplatin + nab-paclitaxel * cisplatin + pemetrexed * cisplatin + gemcitabine Post-operative adjuvant treatment will consist of 16-cycles of atezolizumab
• Placebo Comparator: Arm B: Placebo + platinum-based chemotherapy
  Neoadjuvant treatment will consist of 4 cycles; placebo + platinum-based chemotherapy Platinum-based chemotherapy may include: * carboplatin + pemetrexed * carboplatin + nab-paclitaxel * cisplatin + pemetrexed * cisplatin + gemcitabine Participants will receive best supportive care and monitoring after surgery

Primary Outcome Measure

Independent Review Facility (IRF)-Assessed Event Free Survival (EFS) [ Time Frame: Up to approximately 96 months ]

Locations (29)

Related coverage on Hipa.ai

• Atezolizumab Phase 3 Trial for Resectable NSCLC Completes Primary Data…
  Atezolizumab · Oct 1, 2025 · ClinicalTrials.gov

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