A Study Evaluating the Efficacy and Safety of Adjuvant Platinum-Doublet Chemotherapy, With or Without Atezolizumab, in Patients Who Are ctDNA Positive After Complete Surgical Resection of Stage IB to Select IIIB Non-Small Cell Lung Cancer

• Status: Withdrawn
• Trial end date: 2026-01-08
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase II, multicenter, double-blind, randomized study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab in combination with platinum-doublet chemotherapy followed by atezolizumab compared with adjuvant placebo in combination with platinum-doublet chemotherapy followed by placebo in patients with Stage IB to IIIB (T3N2) NSCLC following surgical resection who are positive for ctDNA.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Atezolizumab; Carboplatin; Gemcitabine; Paclitaxel; Pemetrexed

Criteria

Inclusion Criteria:

• Complete resection (R0) and pathologically confirmed Stage IB to select IIIB NSCLC (8th edition)

• Submission of pre-surgery blood sample and surgically resected tumor tissue slides or block

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

• Normal life expectancy excluding lung cancer mortality risk

• Positive ctDNA status in plasma confirmed by central laboratory testing after surgical resection and prior to start of adjuvant therapy.

Exclusion Criteria:

• Resected NSCLC with positive margins (R1 or R2)

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

• Mixed NSCLC and SCLC histology

• Any prior therapy for lung cancer, including neoadjuvant therapy, or radiotherapy

• NSCLC with an activating EGFR mutation or ALK fusion oncogene

• Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies