Lung cancer breakthrough: could observation replace surgery?
NCT ID NCT06743555
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This pilot study tests whether it is safe and feasible to skip surgery in patients with stage II-III non-small cell lung cancer who have a complete response to chemotherapy and immunotherapy. Fourteen participants will be randomly assigned to either observation or standard surgery. The goal is to see if careful monitoring can be an alternative to surgery without harming outcomes.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 14 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2032
An estimate. End dates often move.
- 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: * \> 18 years of age * The participant has provided documented informed consent for the trial. * Histologically confirmed (by core biopsy) NSCLC and confirmed clinical stages II-III (excluding N2) NSCLC (AJCC 8th edition) amenable to receive neoadjuvant chemo-immunotherapy defined by: nivolumab 3mg/kg Q3W in combination with platinum doublet chemotherapy (cisplatin or carboplatin with paclitaxel or pemetrexed Q3W) for 3 cycles. * PD-L1 tumor proportion score \>50% * Has no history of immunodeficiency, HBV, HCV, HIV. * For female participants: 1. Has no active pregnancy (Refer to "Female participants"). 2. For a woman of child-bearing potential (WOCBP), use of a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least 180 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. 3. A WOCBP must have a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within either 24 hours (urine) or 72 hours (serum) before the first dose of study intervention. 4. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Has adequate hematological, renal and hepatic function per Investigator discretion required for platinum-doublet chemotherapy plus immunotherapy. * Has signed the written consent. Exclusion Criteria: * Has one of the following tumor locations/types: 1. NSCLC involving the superior sulcus 2. Large cell neuro-endocrine cancer (LCNEC) 3. Sarcomatoid tumor * Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Has an active infection requiring systemic therapy. * Has had an allogenic tissue/solid organ transplant. * 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 a known additional malignancy that is progressing or requires active treatment within the past (5 years). Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, bladder carcinoma, or carcinoma in situ (eg, in situ cervical cancer or breast carcinoma) that have undergone potentially curative therapy are not excluded.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4, Canada
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Other studies related to the condition(s) this trial covers.
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