Early lung cancer drug combo trial halted after just 6 patients
NCT ID NCT04638582
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at giving the immunotherapy drug pembrolizumab (Keytruda) alone or with chemotherapy before surgery for people with early-stage non-small cell lung cancer. The goal was to see if these treatments could shrink tumors and improve outcomes. However, the trial was stopped early and only enrolled 6 participants, so results are very limited.
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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
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6 people
The number who actually took part.
- Started
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Aug 2022
- Finished
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Apr 2026
- 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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Accepted
You do not need to have the condition being studied to take part.
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: * Previously untreated, histologically confirmed (by core biopsy) NSCLC and histologically confirmed stages IA3, IB and IIA NSCLC (AJCC 8th edition). * Able to undergo protocol therapy, including necessary surgery. * If female: may participate if no active pregnancy, not breastfeeding, and at least one of the following: is not a woman of childbearing potential (WOCBP), or is a WOCBP using contraceptive methods. * If male: must agree to refrain from donating sperm, and must either be abstinent or agree to use contraception. * ECOG 0-1 * Available formalin-fixed paraffin embedded (FFPE) tumor tissue samples Exclusion Criteria: * Has one of the following tumor locations/types: NSCLC involving the superior sulcus, large cell neuroendocrine cancer (LCNEC) or sarcomatoid tumor. * History of immunodeficiency, HBV, HCV, HIV. No HBV, HCV or HIV testing is required unless mandated by local health authority. * Has a history of (non-infectious) pneumonitis/interstitial lung disease. * Has an active infection requiring systemic therapy. * Has had an allogenic tissue/solid organ transplant. * Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients. (Refer to the respective Investigator's Brochure for a list of excipients.) * Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents and/or to any of their excipients. * Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial. * Has received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant erythropoietin) within 2 weeks before randomization * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137). * Has received prior systemic anticancer therapy including investigational agents for the current malignancy prior to randomization/allocation. * Has received prior radiotherapy within 2 weeks of start of trial treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. * Has received a live or live attenuated vaccine within 30 days prior to the first dose of trial drug. Note: killed vaccines are allowed. * Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (dose exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug. * Has a known additional malignancy that is progressing or requires active treatment within the past (5 years).
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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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McGill University Health Center
Montreal, Quebec, H4A3J1, Canada
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Other studies related to the condition(s) this trial covers.
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