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)

• Status: Active, not recruiting
• Trial end date: 2026-04-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Albumin-Bound Paclitaxel; Antibodies; Antibodies, Monoclonal; Atezolizumab; Carboplatin; Cisplatin; Gemcitabine; Paclitaxel; Pemetrexed

Criteria

Inclusion criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• Histologically or cytologically confirmed, resectable Stage II, IIIA, or Select IIIB (T3N2 only) NSCLC of squamous or non-squamous histology. Staging should be based on the 8th edition of the AJCC/UICC staging system

• Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent

• Adequate pulmonary and cardiac function to undergo surgical resection

• Measurable disease as defined by RECIST v1.1

• Adequate hematologic and end organ function

• Negative HIV test at screening

• Negative for active HBV and HCV at screening

• Adequate tissue for PD-L1 IHC assessment

Exclusion criteria:

• NSCLC with histology of large cell neuroendocrine carcinoma or sarcomatoid carcinoma

• Mixed NSCLC and small cell lung cancer histology

• Any prior therapy for lung cancer

• Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated expected curative outcome

• Non-squamous NSCLC histology with activating ALK and EGFR mutation

• Pregnant or lactating women

• History of autoimmune disease

• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active of active pneumonitis on screening chest Computed Tomography (CT) scan

• Prior treatment with cluster of differentiation 137 (CD137) agonist or immune checkpoint blockade therapies, anti-programmed-death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody

• Severe infection within 4 weeks prior to randomization

• Significant history of cardiovascular disease