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

Hoffmann-La Roche

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Carcinoma, Non-Small Cell Lung

Interventions

AtezolizumabDRUG

Atezolizumab will be administered intravenously during the induction phase and the maintenance phase.

PlaceboDRUG

Placebo will be administered intravenously during the induction phase and the maintenance phase.

CarboplatinDRUG

Carboplatin will be administered intravenously during the induction phase.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

ctDNA Clearance Rate at 6 Months

ctDNA clearance rate at 6 months after randomization, defined as the proportion of participants with undetectable ctDNA at 6 months in the post-operative ctDNA+ participants.

Time frame: Randomization up to 6 months

Disease-Free Survival (DFS)

Disease-free survival (DFS), as assessed by the investigator, and defined as the time from randomization to the date of occurrence of any of the following, whichever occurs first: First documented local or distant recurrence of non-small cell lung cancer (NSCLC) after an integrated assessment of radiographic data, biopsy sample results (if available), and clinical status; Occurrence of new primary NSCLC (non-small cell lung cancer); Death from any cause in the post-operative ctDNA+ participants

Time frame: Randomization up to approximatly 159 months

Secondary Outcomes

ctDNA Clearance Rate at 12 Months

ctDNA clearance rate in post-operative ctDNA+ participants.

Time frame: Randomization up to 12 months

Overall ctDNA Clearance Rate

Overall ctDNA clearance rate in post-operative ctDNA+ participants.

Time frame: Randomization up to approximately 159 months

Duration of ctDNA Clearance

Duration of ctDNA clearance, defined as the time from the first documented ctDNA clearance to ctDNA detection, investigator-assessed radiographic or biopsy confirmed disease recurrence, or death from any cause, whichever occurs first in post-operative ctDNA+ participants.

Time frame: Up to approximatly 159 months

Overall survival (OS)

Overall survival (OS) after randomization, defined as the time from randomization to death from any cause in the post-operative ctDNA+ participants.

Data from ClinicalTrials.gov

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