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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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ClinicalTrials.gov Identifier: NCT04267237
Recruitment Status : Recruiting
First Posted : February 12, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer (NSCLC) Drug: Atezolizumab Drug: RO7198457 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : August 17, 2020
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Atezolizumab
Participants will receive atezolizumab on Day 1 of each 28-day cycle (Q4W) for 12 cycles.
Drug: Atezolizumab
Atezolizumab 1680 mg will be administered by intravenous (IV) infusion on Day 1 of Cycles 1-12.
Other Name: Tecentriq

Experimental: Atezolizumab + RO7198457
Participants will receive atezolizumab Q4W along with RO7198457 for 12 cycles.
Drug: Atezolizumab
Atezolizumab 1680 mg will be administered by intravenous (IV) infusion on Day 1 of Cycles 1-12.
Other Name: Tecentriq

Drug: RO7198457
RO7198457 will be administered by IV infusion at protocol-defined intervals for 12 cycles.




Primary Outcome Measures :
  1. Disease-free Survival (DFS) [ Time Frame: Up to 62 months ]
    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.


Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267237


Contacts
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Contact: Reference Study ID Number: GO41836 www.roche.com/about_roche/roche_worldwide.html 888-662-6728 (US Only) global-roche-genentech-trials@gene.com

Locations
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United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04267237    
Other Study ID Numbers: GO41836
2019-003449-14 ( EudraCT Number )
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hoffmann-La Roche:
Cancer vaccine
Neoantigen
Personalized
Atezolizumab
Vaccine
Immunotherapy
Anti-PDL1
Checkpoint Inhibitor
Personalized vaccine
Non-small cell lung cancer
NSCLC
Adjuvant
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Atezolizumab
Antineoplastic Agents