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)

Roche

Status and phase: Active, not recruiting; Phase 3

Conditions: Non-Small-Cell Lung

Treatments: Drug: Cisplatin; Drug: Carboplatin; Drug: Placebo Comparator; Drug: Pemetrexed; Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody

Study type: Interventional

Funder types: Industry

Identifiers

NCT03456063

GO40241

Details and patient eligibility

About

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.

Enrollment: 453 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• Significant history of cardiovascular disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

453 participants in 2 patient groups, including a placebo group

Arm A: Atezolizumab + platinum-based chemotherapy

Experimental group

Description:

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

Treatment:

Drug: Gemcitabine

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

Drug: Nab-paclitaxel

Drug: Pemetrexed

Drug: Carboplatin

Drug: Cisplatin

Arm B: Placebo + platinum-based chemotherapy

Placebo Comparator group

Description:

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

Treatment:

Drug: Gemcitabine

Drug: Nab-paclitaxel

Drug: Pemetrexed

Drug: Placebo Comparator

Drug: Carboplatin

Drug: Cisplatin