A Phase 2 interventional study of Atezolizumab and RO7198457 in Non-small Cell Lung Cancer (NSCLC), sponsored by Hoffmann-La Roche. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-04.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This study will evaluate the efficacy, safety, pharmacokinetics, immunogenicity and biomarkers of RO7198457 plus atezolizumab compared with atezolizumab alone in patients with Stage II-III non-small cell lung cancer (NSCLC) who are circulating tumor DNA (ctDNA) positive following surgical resection and have received standard-of-care adjuvant platinum-doublet chemotherapy.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
Browse Lung Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
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Exclusion Criteria:
Participants will receive atezolizumab on Day 1 of each 28-day cycle (Q4W) for 12 cycles.
Drug: Atezolizumab
Participants will receive atezolizumab Q4W along with RO7198457 for 12 cycles.
Drug: Atezolizumab · Drug: RO7198457
Atezolizumab 1680 mg will be administered by intravenous (IV) infusion on Day 1 of Cycles 1-12.
Also known as: Tecentriq
RO7198457 will be administered by IV infusion at protocol-defined intervals for 12 cycles.
Disease-free Survival (DFS)
DFS as assessed by the investigator, is defined as the time from randomization to the date of first documented recurrence of NSCLC or occurrence of new primary NSCLC or death due to any cause, whichever occurs first.
Time frame: Up to 62 months
Percentage of Participants with Adverse Events (AEs) and Serious AEs (SAEs) determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Time frame: Up to 90 days after the final dose of study drug or until initiation of another systemic anti-cancer therapy (up to approximately 62 months)
Plasma Concentrations of RNA at Specified Timepoints
Time frame: Arm B: Days 1, 8, 15, 22 of Cycle 1 (each cycle is 28 days), Day 1 of Cycle 2, 3, 5, 7, 9, 11 and treatment discontinuation (TD) visit (up to 12 months)
Plasma Concentrations of (R)-N,N,N-trimethyl-2,3-dioleyloxy-1-propanaminium chloride (DOTMA) at Specified Timepoints
Time frame: Arm B: Days 1, 8, 15, 22 of Cycle 1 (each cycle is 28 days), Day 1 of Cycle 2, 3, 5, 7, 9, 11 and treatment discontinuation (TD) visit (up to 12 months)
Maximum Serum Concentration (Cmax) of Atezolizumab at Specified Timepoints
Time frame: Arm A and Arm B: Day 1 of Cycles 1-4 (each cycle is 28 days) and at TD visit (up to 12 months)
Minimum Serum Concentration (Cmin) of Atezolizumab at Specified Timepoints
Time frame: Arm A and Arm B: Day 1 of Cycles 1-4 (each cycle is 28 days) and at TD visit (up to 12 months)
Change from Baseline in Number of Participants With Anti-drug Antibodies (ADA) to Atezolizumab
Time frame: Arm A and Arm B: Baseline, Day 1 of Cycles 1-4 (each cycle is 28 days) and at TD visit (up to 12 months)
No study locations are listed for this record.
Plan to share: Yes — Qualified researchers may request access to individual patient level data through the clinical study data request platform(www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
No publications or documents are linked to this record.
This study is withdrawn, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche