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Study of Nivolumab-Ipilimumab and cfDNA in Lung Cancer (ATLAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04966676
Recruitment Status : Recruiting
First Posted : July 19, 2021
Last Update Posted : May 16, 2022
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE July 8, 2021
First Posted Date  ICMJE July 19, 2021
Last Update Posted Date May 16, 2022
Actual Study Start Date  ICMJE January 24, 2022
Estimated Primary Completion Date November 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2021)		 Percentage of participants whose disease does not worsen (progression-free survival rate) at 6 months [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2021)		 Progression-free survival [ Time Frame: 4 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2021)
  • Average percentage of tumor cfDNA detected in the blood (tumor cfDNA clearance rate) at 3 weeks [ Time Frame: 3 weeks ]
  • Average percentage of tumor cfDNA detected in the blood (tumor cfDNA clearance rate) at 12 weeks [ Time Frame: 12 weeks ]
  • Number participants with adverse events [ Time Frame: 4 years ]
  • Average time from the date of study enrolment until death (overall survival) [ Time Frame: 4 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2021)
  • Tumor cfDNA clearance rates [ Time Frame: 3 weeks ]
  • Tumor cfDNA clearance rates [ Time Frame: 12 weeks ]
  • Number of adverse events [ Time Frame: 4 years ]
  • Overall survival [ Time Frame: 4 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Nivolumab-Ipilimumab and cfDNA in Lung Cancer
Official Title  ICMJE Beyond Chemotherapy: Nivolumab-Ipilimumab With cfDNA-guided Treatment Intensification as a Chemotherapy-sparing Strategy in Metastatic Non-small Cell Lung Cancer
Brief Summary The purpose of this research study is to look at how effective two drugs, nivolumab and ipilimumab, are for people with non-small lung cancer that has metastasized (has spread to other parts of the body) and to see what effects these drugs have on these tumors.
Detailed Description The study will use a special blood test to evaluate the response of the cancer to treatment. This blood test will analyze tumor DNA present in the blood (deoxyribonucleic acid, molecules that contain instructions for the development and function of cells). Patients that do not have evidence of a good response using this blood test will also undergo a short course of chemotherapy in addition to nivolumab and ipilimumab.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Small Cell Lung Cancer
Intervention  ICMJE
  • Diagnostic Test: cfDNA blood test
    Blood sample will be taken for cfDNA testing
  • Drug: Nivolumab
    Antineoplastic agent
  • Drug: Ipilimumab
    Antineoplastic agent
  • Combination Product: Platinum-based Chemotherapy
    May include carboplatin with gemcitabine, or paclitaxel or pemetrexed
Study Arms  ICMJE Experimental: Non-Small cell Lung Cancer

Nivolumab, intravenously (given by vein), once every 3 weeks Ipilimumab, intravenously (given by vein), once every 6 weeks

Participants will have blood samples taken for cell free deoxyribonucleic acid (cfDNA) testing.

If there is an increasing or stable tumor cfDNA, platinum-doublet chemotherapy will be given.

Interventions:
  • Diagnostic Test: cfDNA blood test
  • Drug: Nivolumab
  • Drug: Ipilimumab
  • Combination Product: Platinum-based Chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2021)		 50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2025
Estimated Primary Completion Date November 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years at the time of screening or age of consent.
  • Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Weight ≥ 35 kg.
  • Must have a life expectancy of at least 12 weeks.
  • Recurrent or newly diagnosed metastatic non-small cell lung cancer
  • Tumor PDL1 status <50%.
  • Non-Squamous and squamous histologies are eligible
  • Histologies with targetable mutations are not eligible, regardless of prior treatment with tyrosine kinase inhibitors
  • No prior radiation, surgery or chemotherapy is allowed for the current diagnosis of non-small cell lung cancer
  • Adequate organ and marrow function

Exclusion Criteria:

  • Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment.
  • Prior receipt of any immune-mediated therapy.
  • Incomplete surgical resection
  • Concurrent enrolment in another therapeutic clinical study. Enrolment in observational studies will be allowed.
  • Any toxicity (excluding alopecia) from prior standard therapy that has not been completely resolved to baseline at the time of consent.
  • Participants with prior history of myocardial infarction, transient ischemic attack, congestive heart failure ≥ Class 3 based on New York Heart Association Functional Classification or stroke within the past 3 months prior to the scheduled first dose of study treatment.
  • Active or prior documented autoimmune disorders within the past 3 years prior to the scheduled first dose of study treatment with exceptions.
  • Participants with confirmed human immunodeficiency virus (even if viral load is undetectable), chronic or active hepatitis B or C, or active hepatitis A.
  • History of primary immunodeficiency, solid organ transplantation, or active tuberculosis (by clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice).
  • Other invasive malignancy within 2 years. Non-invasive malignancies (i.e., cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured) are excluded from this definition.
  • Known allergy or hypersensitivity to investigational product formulations.
  • History of more than one event of infusion related reactions requiring permanent discontinuation of intravenous drug treatment.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring antibiotic therapy, uncontrolled hypertension, bleeding diatheses, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring adverse events, or compromise the ability of the subject to give written informed consent.
  • Current or prior use of immunosuppressive medication within 14 days prior to the scheduled first dose of study treatment with exceptions.
  • Receipt of live, attenuated vaccine within 30 days prior to the scheduled first dose of study treatment - Major surgery within 28 days prior to scheduled first dose of study treatment or still recovering from prior surgery.
  • Females who are pregnant, lactating, or intend to become pregnant during their participation in the study.
  • Participants who are involuntarily incarcerated or are unable to willingly provide consent or are unable to comply with the protocol procedures.
  • Any condition that, in the opinion of the investigator, would interfere with safe administration or evaluation of the investigational products or interpretation of subject safety or study results.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Adrian Sacher, M.D. 416-946-4501 ext 3550 adrian.sacher@uhn.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04966676
Other Study ID Numbers  ICMJE ATLAS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Health Network, Toronto
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Health Network, Toronto
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Principal Investigator: Adrian Sacher, M.D. Princess Margaret Cancer Centre
PRS Account University Health Network, Toronto
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP