Study of Nivolumab-Ipilimumab and cfDNA in Lung Cancer (ATLAS)
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|ClinicalTrials.gov Identifier: NCT04966676|
Recruitment Status : Recruiting
First Posted : July 19, 2021
Last Update Posted : May 16, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Non Small Cell Lung Cancer||Diagnostic Test: cfDNA blood test Drug: Nivolumab Drug: Ipilimumab Combination Product: Platinum-based Chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Beyond Chemotherapy: Nivolumab-Ipilimumab With cfDNA-guided Treatment Intensification as a Chemotherapy-sparing Strategy in Metastatic Non-small Cell Lung Cancer|
|Actual Study Start Date :||January 24, 2022|
|Estimated Primary Completion Date :||November 1, 2025|
|Estimated Study Completion Date :||November 1, 2025|
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.
Diagnostic Test: cfDNA blood test
Blood sample will be taken for cfDNA testing
Combination Product: Platinum-based Chemotherapy
May include carboplatin with gemcitabine, or paclitaxel or pemetrexed
- Percentage of participants whose disease does not worsen (progression-free survival rate) at 6 months [ Time Frame: 6 months ]
- 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 ]
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.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
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): NCT04966676
|Contact: Adrian Sacher, M.D.||416-946-4501 ext firstname.lastname@example.org|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Adrian Sacher, M.D. 416-946-4501 ext 3550|
|Principal Investigator: Adrian Sacher, M.D.|
|Principal Investigator:||Adrian Sacher, M.D.||Princess Margaret Cancer Centre|
|Responsible Party:||University Health Network, Toronto|
|Other Study ID Numbers:||
|First Posted:||July 19, 2021 Key Record Dates|
|Last Update Posted:||May 16, 2022|
|Last Verified:||May 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action