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
NCT ID: NCT04611776
Last Updated: 2021-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2021-07-01
2026-01-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm A: Atezolizumab + platinum-doublet followed by atezolizumab maintenance
Atezolizumab
Atezolizumab 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.
Arm B: Placebo + platinum-doublet followed by placebo maintenance
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Other Identifiers
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YO41867
Identifier Type: -
Identifier Source: org_study_id
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