Clinical trial NCT04611776: 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
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small Cell Lung
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2020-11-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: ctDNA Clearance Rate at 6 Months
timeFrame: Randomization up to 6 months
measure: Disease-Free Survival (DFS)
timeFrame: Randomization up to approximatly 159 months
Secondary outcomes:
measure: ctDNA Clearance Rate at 12 Months
timeFrame: Randomization up to 12 months
measure: Overall ctDNA Clearance Rate
timeFrame: Randomization up to approximately 159 months
measure: Duration of ctDNA Clearance
timeFrame: Up to approximatly 159 months
measure: Overall survival (OS)
timeFrame: Randomization to death from any cause (up to approximately 159 months)
measure: DFS Rate
timeFrame: Randomization to 2 years and 3 years
measure: Overall ctDNA Clearance Rate in the PD-L1 TC>=1% Population
timeFrame: Randomization up to approximately 159 months
measure: OS Rate
timeFrame: Randomization to 2 years and 3 years
measure: Time to Confirmed Deterioration (TTCD) in Patient-Reported Functioning and Global Health (GHS)/Quality of Life (QoL)
timeFrame: Up to approximately 159 months
measure: Percentage of Pariticipants with Adverse Events
timeFrame: Randomization up to approximatly 159 months
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: