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 (CATHAYA)

Roche

Status and phase: Withdrawn; Phase 2

Conditions: Carcinoma, Non-Small Cell Lung

Treatments: Drug: Pemetrexed; Drug: Cisplatin; Drug: Gemcitabine; Drug: Placebo; Drug: Carboplatin; Drug: Paclitaxel; Drug: Atezolizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04611776

YO41867

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance

Experimental group

Treatment:

Drug: Atezolizumab

Drug: Cisplatin

Drug: Pemetrexed

Drug: Carboplatin

Drug: Paclitaxel

Drug: Gemcitabine

Arm B: Placebo + platinum-doublet followed by placebo maintenance

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Cisplatin

Drug: Pemetrexed

Drug: Carboplatin

Drug: Paclitaxel

Drug: Gemcitabine