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

Carcinoma, Non-Small Cell Lung Clinical Trial

— CATHAYA  

Official title:

A Phase II, Randomized, Double-Blind, Placebo-Controlled 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04611776
• Other study ID #: YO41867
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 1, 2021
• Est. completion date: January 8, 2026

Study information

• Verified date: June 2021
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 8, 2026
• Est. primary completion date: March 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small Cell Lung
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Atezolizumab
Atezolizumab will be administered intravenously during the induction phase and the maintenance phase.
• Placebo
Placebo will be administered intravenously during the induction phase and the maintenance phase.
• Carboplatin
Carboplatin will be administered intravenously during the induction phase.
• Cisplatin
Cisplatin will be administered intravenously during the induction phase.
• Pemetrexed
Pemetrexed will be administered intravenously during the induction phase.
• Gemcitabine
Gemcitabine will be administered intravenously during the induction phase.
• Paclitaxel
Paclitaxel will be administered intravenously during the induction phase.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	ctDNA Clearance Rate at 12 Months	ctDNA clearance rate in post-operative ctDNA+ participants.	Randomization up to 12 months
Secondary	Overall ctDNA Clearance Rate	Overall ctDNA clearance rate in post-operative ctDNA+ participants.	Randomization up to approximately 159 months
Secondary	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.	Up to approximatly 159 months
Secondary	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.	Randomization to death from any cause (up to approximately 159 months)
Secondary	DFS Rate	DFS rate at 2 years and 3 years, defined as the probability that a participant has not experienced disease recurrence, a new primary NSCLC, or death from any cause, as determined by the investigator at 2 years and 3 years, respectively in the post-operative ctDNA+ participants.	Randomization to 2 years and 3 years
Secondary	Overall ctDNA Clearance Rate in the PD-L1 TC>=1% Population	Overall ctDNA clearance rate in the PD-L1 TC>=1% (Ventana SP263) population in the post-operative ctDNA+ participants.	Randomization up to approximately 159 months
Secondary	OS Rate	OS rate at 2 years and 3 years, defined as the probability that a patient has not experienced death from any cause at 2 years and 3 years, respectively in the post-operative ctDNA+ participants.	Randomization to 2 years and 3 years
Secondary	Time to Confirmed Deterioration (TTCD) in Patient-Reported Functioning and Global Health (GHS)/Quality of Life (QoL)	Time to confirmed deterioration (TTCD) in patient-reported functioning and global health (GHS)/quality of life (QoL), as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30), and in patient-reported lung cancer symptoms for cough, dyspnea (a multi-item subscale), and chest pain, as measured through the use of the EORTC Quality-of-Life Questionnaire Lung Cancer Module (QLQ-LC13) in the post-operative ctDNA+ participants.	Up to approximately 159 months
Secondary	Percentage of Pariticipants with Adverse Events	Percentage of participants with adverse events in the post-operative ctDNA+ participants.	Randomization up to approximatly 159 months