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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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)

A Phase III, Double-Blinded, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment With Atezolizumab or Placebo in Combination With Platinum-Based Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer

NCT03456063•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (122)

Arizona Oncology

Tucson, Arizona, United States

USC Norris Cancer Center

Los Angeles, California, United States

The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange

Orange, California, United States

UC Davis Cancer Center

Sacramento, California, United States

Scripps Clinic

San Diego, California, United States

National Jewish Health

Denver, Colorado, United States

Rocky Mountain Cancer Center

Denver, Colorado, United States

Georgetown University

Washington D.C., District of Columbia, United States

Washington Cancer Institute

Washington D.C., District of Columbia, United States

Illinois Cancer Care

Peoria, Illinois, United States

Key Dates

Start Date

April 24, 2018

Primary Completion Date

October 1, 2025

Completion Date

December 31, 2025

Last Updated

January 22, 2026

Enrollment

453

ACTUAL participants

Conditions

Non-Small-Cell Lung

Interventions

Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

DRUG

Placebo Comparator

DRUG

Nab-paclitaxel

DRUG

Pemetrexed

DRUG

Carboplatin

DRUG

Cisplatin

DRUG

Gemcitabine

DRUG

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

NCT07336732

Non-Small-Cell Lung Cancer

View study

RECRUITINGPHASE2

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

NCT06667908

Carcinoma, Non-Small-Cell Lung

View study

RECRUITING

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

A Study of LY4175408 in Participants With Advanced Cancer

A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer