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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04267237
Registration number
NCT04267237
Ethics application status
Date submitted
7/02/2020
Date registered
12/02/2020
Date last updated
4/02/2021
Titles & IDs
Public title
A Study of the Efficacy and Safety of RO7198457 in Combination With Atezolizumab Versus Atezolizumab Alone Following Adjuvant Platinum-Doublet Chemotherapy in Participants Who Are ctDNA Positive After Surgical Resection of Stage II-III Non-Small Cell Lung Cancer
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Scientific title
A Phase II, Open-label, Multicenter, Randomized Study of the Efficacy and Safety of RO7198457 in Combination With Atezolizumab Versus Atezolizumab Alone Following Adjuvant Platinum-doublet Chemotherapy in Patients Who Are ctDNA Positive After Surgical Resection of Stage II-III Non-small Cell Lung Cancer
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Secondary ID [1]
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2019-003449-14
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Secondary ID [2]
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GO41836
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer (NSCLC)
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - RO7198457
Experimental: Atezolizumab - Participants will receive atezolizumab on Day 1 of each 28-day cycle (Q4W) for 12 cycles.
Experimental: Atezolizumab + RO7198457 - Participants will receive atezolizumab Q4W along with RO7198457 for 12 cycles.
Treatment: Drugs: Atezolizumab
Atezolizumab 1680 mg will be administered by intravenous (IV) infusion on Day 1 of Cycles 1-12.
Treatment: Drugs: RO7198457
RO7198457 will be administered by IV infusion at protocol-defined intervals for 12 cycles.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease-free Survival (DFS)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 62 months
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Secondary outcome [1]
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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)
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Assessment method [1]
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Timepoint [1]
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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)
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Secondary outcome [2]
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Plasma Concentrations of RNA at Specified Timepoints
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Assessment method [2]
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Timepoint [2]
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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)
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Secondary outcome [3]
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Plasma Concentrations of (R)-N,N,N-trimethyl-2,3-dioleyloxy-1-propanaminium chloride (DOTMA) at Specified Timepoints
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Assessment method [3]
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Timepoint [3]
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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)
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Secondary outcome [4]
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Maximum Serum Concentration (Cmax) of Atezolizumab at Specified Timepoints
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Assessment method [4]
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Timepoint [4]
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Arm A and Arm B: Day 1 of Cycles 1-4 (each cycle is 28 days) and at TD visit (up to 12 months)
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Secondary outcome [5]
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Minimum Serum Concentration (Cmin) of Atezolizumab at Specified Timepoints
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Assessment method [5]
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Timepoint [5]
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Arm A and Arm B: Day 1 of Cycles 1-4 (each cycle is 28 days) and at TD visit (up to 12 months)
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Secondary outcome [6]
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Change from Baseline in Number of Participants With Anti-drug Antibodies (ADA) to Atezolizumab
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Assessment method [6]
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Timepoint [6]
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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)
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Eligibility
Key inclusion criteria
- Age >= 18 years;
- Resected Stage II-III Non-small Cell Lung Cancer (NSCLC) per American Joint Committee
on Cancer staging criteria, 8th revised edition;
- Complete R0 resection of Stage II or III NSCLC prior to enrollment and adequate
recovery from surgery;
- Pathological evaluation of mediastinal lymph nodes preoperatively or intraoperatively;
- ctDNA (circulating tumor DNA) identified in plasma after resection of Stage II-III
NSCLC and prior to start of adjuvant platinum-doublet therapy, as determined by
central testing;
- Treatment with at least two cycles of adjuvant platinum-doublet chemotherapy regimens
for resected NSCLC;
- No unequivocal evidence of disease after surgery and adjuvant platinum-doublet
chemotherapy, as assessed on imaging (computed tomography [CT] scan or magnetic
resonance imaging [MRI]) within 28 days prior to randomization;
- Availability of adequate tumor material;
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1;
- Adequate hematologic and end-organ function;
- Negative HIV test at screening;
- Negative hepatitis B test at screening;
- Negative hepatitis C test at screening.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participants with a known mutation in exons 18-21 of epidermal growth factor receptor
(EGFR) or with a known anaplastic lymphoma kinase (ALK) or reactive oxygen species
(ROS) alteration;
- History of malignancy other than disease under study within 5 years prior to
enrollment, with the exception of malignancies with a negligible risk of metastasis or
death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin
cancer, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine
cancer;
- Induction and neoadjuvant systemic therapy prior to resection of NSCLC;
- Radiotherapy prior to or after resection of NSCLC;
- Prior systemic investigational therapy;
- Prior anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, or a cancer
vaccine;
- Treatment with systemic immunostimulatory agents within 6 weeks or 5 drug elimination
half-lives, prior to initiation of study treatment;
- Treatment with systemic immunosuppressive medication within 2 weeks prior to
initiation of study treatment or anticipation of need for systemic immunosuppressive
medication during study treatment;
- Treatment with monoamine oxidase inhibitors (MAOIs) within 3 weeks prior to initiation
of study treatment or requirement for ongoing treatment with MAOIs;
- Active or history of autoimmune disease or immune deficiency;
- Known primary immunodeficiencies, either cellular or combined T-cell and B-cell
immunodeficiencies;
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening
chest CT scan;
- Significant cardiovascular disease;
- Major surgical procedure, other than for diagnosis or for resection of disease under
current study, within 4 weeks prior to initiation of study treatment, or anticipation
of need for a major surgical procedure during the study;
- Known active or latent tuberculosis infection;
- Recent acute infection;
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study
treatment, or anticipation of need for such a vaccine during study treatment or within
5 months after the final dose of study treatment;
- Prior allogeneic stem cell or solid organ transplantation;
- Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that contraindicates the use of an investigational drug, may affect
the interpretation of the results, or may render the participants at high risk from
treatment complications;
- Known clinically significant liver disease;
- Previous splenectomy;
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies
or fusion proteins;
- Known hypersensitivity to Chinese hamster ovary cell products or any component of the
atezolizumab formulation;
- Known allergy or hypersensitivity to any component of RO7198457;
- Pregnant or lactating women.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
31/03/2021
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/09/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04267237
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Address
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Hoffmann-La Roche
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04267237
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