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)

Purpose

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.

Condition

  • Non-Small-Cell Lung

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
    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
    Other names:
    • Tecentriq
  • Drug: Nab-paclitaxel
    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
    Other names:
    • Abraxane
  • Drug: Pemetrexed
    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
    Other names:
    • Alimta
  • Drug: Carboplatin
    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
  • Drug: Cisplatin
    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
  • Drug: Gemcitabine
    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
    Other names:
    • Gemzar
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
  • Drug: Placebo Comparator
    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
  • Drug: Nab-paclitaxel
    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
    Other names:
    • Abraxane
  • Drug: Pemetrexed
    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
    Other names:
    • Alimta
  • Drug: Carboplatin
    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
  • Drug: Cisplatin
    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
  • Drug: Gemcitabine
    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
    Other names:
    • Gemzar

More Details

Status
Active, not recruiting
Sponsor
Hoffmann-La Roche

Study Contact