Chemo-Free hope for lung cancer: new drug combo tested
NCT ID NCT04966676
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two immunotherapy drugs, nivolumab and ipilimumab, in people with advanced non-small cell lung cancer that had spread. The goal was to see if these drugs could control the cancer without needing chemotherapy. Only 5 people took part before the study was stopped early.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
5 people
The number who actually took part.
- Started
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Jan 2022
- Finished
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Feb 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 (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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new drug shrink advanced solid tumors?
- Can a less extensive lung cancer surgery be just as effective?