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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

NCT04611776

WithdrawnPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Carcinoma, Non-Small Cell Lung

Interventions: Atezolizumab, Placebo, Carboplatin, Cisplatin, Pemetrexed

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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