Non Small Cell Lung CancerPhase 2ATLASNCT04966676
Study of Nivolumab-Ipilimumab and cfDNA in Lung Cancer
A Phase 2 study testing cfDNA blood test, Nivolumab and Ipilimumab in people with Non Small Cell Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- cfDNA blood test, Nivolumab and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jan 2022to 19 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Tumor PDL1 status <50%.
- Non-Squamous and squamous histologies are eligible
- Histologies with targetable mutations (EGFR, ALK, ROS1) 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beyond Chemotherapy: Nivolumab-Ipilimumab With cfDNA-guided Treatment Intensification as a Chemotherapy-sparing Strategy in Metastatic Non-small Cell Lung Cancer
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.
Read the 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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- cfDNA blood test, Nivolumab, Ipilimumab, Platinum-based Chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cfDNA blood testDiagnostic test
Blood sample will be taken for cfDNA testing
NivolumabDrug
Also called Opdivo®, BMS-936558 or MDX1106
Antineoplastic agent
IpilimumabDrug
Also called BMS-734016, MDX010, MDX-CTLA4
Antineoplastic agent
Platinum-based ChemotherapyCombination product
May include carboplatin with gemcitabine, or paclitaxel or pemetrexed
| Study group | Role | What they receive |
|---|---|---|
| Non-Small cell Lung Cancer | Experimental | 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. Receives: Diagnostic Test: cfDNA blood test; Drug: Nivolumab; Drug: Ipilimumab; Combination Product: Platinum-based Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants whose disease does not worsen (progression-free survival rate) at 6 months
Progression-free survival (PFS) and 6-month PFS rate, as per RECIST 1.1, will be estimated using the Kaplan-Meier method together with their 95% confidence limit. The PFS of the study cohort will be compared to the historical controls derived from the CM9LA study.
Measured: 6 months
Secondary outcomes (4)
Average percentage of tumor cfDNA detected in the blood (tumor cfDNA clearance rate) at 3 weeks
To estimate the clearance of ctDNA at 3 weeks post treatment in those receiving ipilimumab-nivolumab +/- chemotherapy
Measured: 3 weeks
Average percentage of tumor cfDNA detected in the blood (tumor cfDNA clearance rate) at 12 weeks
To estimate the clearance of ctDNA at 12 weeks post treatment in those receiving ipilimumab-nivolumab +/- chemotherapy
Measured: 12 weeks
Number participants with adverse events
To evaluate the toxicity experienced by patients receiving ipilimumab-nivolumab with cfDNA-directed treatment-intensification with platinum-based chemotherapy.
Measured: 4 years
Average time from the date of study enrolment until death (overall survival)
To evaluate the overall survival (OS) of patients receiving ipilimumab-nivolumab with cfDNA directed treatment-intensification with platinum-based chemotherapy.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start24 Jan 2022
- Primary completion19 Feb 2025
- Study completion19 Feb 2025
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Adrian Sacher, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966676
- Sponsor's protocol ID
- ATLAS
- Acronym
- ATLAS
- Status last verified
- Jan 2026
- First submitted
- 8 Jul 2021
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond Chemotherapy: Nivolumab-Ipilimumab With cfDNA-guided Treatment Intensification as a Chemotherapy-sparing Strategy in Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04966676
- Acronym / sponsor ID
- ATLAS / ATLAS
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 19 Feb 2025 (actual)
- Study completion
- 19 Feb 2025 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-Small cell Lung Cancer | Experimental | Diagnostic Test: cfDNA blood test, Drug: Nivolumab, Drug: Ipilimumab, Combination Product: Platinum-based ChemotherapyNivolumab, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cfDNA blood testBlood sample will be taken for cfDNA testing | Diagnostic test | Non-Small cell Lung Cancer |
| NivolumabAlso: Opdivo®, BMS-936558 or MDX1106Antineoplastic agent | Drug | Non-Small cell Lung Cancer |
| IpilimumabAlso: BMS-734016, MDX010, MDX-CTLA4Antineoplastic agent | Drug | Non-Small cell Lung Cancer |
| Platinum-based ChemotherapyMay include carboplatin with gemcitabine, or paclitaxel or pemetrexed | Combination product | Non-Small cell Lung Cancer |
Primary outcome
Percentage of participants whose disease does not worsen (progression-free survival rate) at 6 months
Time frame: 6 months
Progression-free survival (PFS) and 6-month PFS rate, as per RECIST 1.1, will be estimated using the Kaplan-Meier method together with their 95% confidence limit. The PFS of the study cohort will be compared to the historical controls derived from the CM9LA study.
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Sacher, M.D. principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cfDNA blood test, Nivolumab and Ipilimumab in people with Non Small Cell Lung Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants whose disease does not worsen (progression-free survival rate) at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.