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)

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2024
• Main ID: NCT03456063
• Date of registration: 05/03/2018
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: 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)
• Scientific title: 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
• Date of first enrolment: April 24, 2018
• Target sample size: 453
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03456063
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non-Small-Cell Lung

Intervention(s)

Drug: Nab-paclitaxel

Drug: Placebo Comparator

Drug: Gemcitabine

Drug: Cisplatin

Drug: Pemetrexed

Drug: Carboplatin

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

Primary Outcome(s)

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

Secondary Outcome(s)

Maximum Observed Serum Atezolizumab Concentration (Cmax) [Time Frame: Pre-dose on Day 1 of Cycles 1 and 3 for Neoadjuvant Treatment; Pre-dose on Day 1 of Cycles 5, 7, 9, 11 and 19 for Arm A. Each cycle is 21 days; at treatment or observation follow-up discontinuation (up to approximately 96 months)]

Minimum Observed Serum Atezolizumab Concentration (Cmin) [Time Frame: Pre-dose on Day 1 of Cycles 1 and 3 (each cylce is 21 days) for Neoadjuvant Treatment; pre-dose on Day 1 of Cycles 5, 7, 9, 11 and 19 (each cycle is 21 days) for Arm A; at treatment or observation follow-up discontinuation (up to approximately 96 months)]

2-Year and 3-Year Investigator-Assessed EFS [Time Frame: Up to approximately 96 months]

Length of Surgical Delays [Time Frame: Up to approximately 96 months]

Investigator-Assessed EFS [Time Frame: Up to approximately 96 months]

2-Year and 3-Year Independent Review Facility-Assessed EFS [Time Frame: Up to approximately 96 months]

2-Year and 3-Year OS [Time Frame: Up to approximately 96 months]

Change from baseline in HRQoL scores [Time Frame: Up to approximately 96 months]

Disease-Free Survival (DFS) [Time Frame: Up to approximately 96 months]

Number of Operative and Post-Operative Complications [Time Frame: Up to approximately 96 months]

Pathological Complete Response (pCR) [Time Frame: At time of surgery]

Overall Survival (OS) [Time Frame: Up to approximately 96 months]

Number and Severity of Surgical Related Adverse Events [Time Frame: Up to approximately 96 months]

Objective Response (OR) [Time Frame: Prior to surgery, up to approximately 84 days]

Percentage of Participants With Adverse Events (AEs) [Time Frame: Up to approximately 96 months]

Percentage of Participants With Anti-Drug Antibody (ADA) to Atezolizumab [Time Frame: Pre-dose on Day 1 of Cycles 1 and 3 for Neoadjuvant Treatment; Pre-dose on Day 1 of Cycles 5, 7, 9, 11 and 19 for Arm A. Each cycle is 21 days; at treatment or observation follow-up discontinuation (up to approximately 96 months)]

Major Pathological Response (MPR) [Time Frame: At time of surgery]

Number of Surgical Delays [Time Frame: Up to approximately 96 months]

Reasons for Surgical Cancellations [Time Frame: Up to approximately 96 months]

Secondary ID(s)

GO40241

Source(s) of Monetary Support

Please refer to primary and secondary sponsors