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NCT04611776 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: YO41867
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Carcinoma, Non-Small Cell Lung

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Randomization up to approximatly 159 months

Secondary Outcomes (9)

• ctDNA Clearance Rate at 12 Months

  Randomization up to 12 months

• Overall ctDNA Clearance Rate

  Randomization up to approximately 159 months

• Duration of ctDNA Clearance

  Up to approximatly 159 months

• Overall survival (OS)

  Randomization to death from any cause (up to approximately 159 months)

• DFS Rate

  Randomization to 2 years and 3 years

Study Arms (2)

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

EXPERIMENTAL

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

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

PLACEBO COMPARATOR

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

Interventions

Atezolizumab DRUG

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

Also known as: Tecentriq

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

Placebo DRUG

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

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

Carboplatin DRUG

Carboplatin will be administered intravenously during the induction phase.

Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance; Arm B: Placebo + platinum-doublet followed by placebo maintenance

Cisplatin DRUG

Cisplatin will be administered intravenously during the induction phase.

Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance; Arm B: Placebo + platinum-doublet followed by placebo maintenance

Pemetrexed DRUG

Pemetrexed will be administered intravenously during the induction phase.

Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance; Arm B: Placebo + platinum-doublet followed by placebo maintenance

Gemcitabine DRUG

Gemcitabine will be administered intravenously during the induction phase.

Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance; Arm B: Placebo + platinum-doublet followed by placebo maintenance

Paclitaxel DRUG

Paclitaxel will be administered intravenously during the induction phase.

Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance; Arm B: Placebo + platinum-doublet followed by placebo maintenance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

atezolizumab; Carboplatin; Cisplatin; Pemetrexed; Gemcitabine; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2020
• First Posted: November 2, 2020
• Study Start: July 1, 2021
• Primary Completion: March 6, 2025
• Study Completion: January 8, 2026
• Last Updated: June 16, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share