Surgery After Verifying Existing Disease in Locally Advanced Operable Lung Cancer: A Pilot Study

Official record

Identifier

NCT06743555

Recruiting locations

country

Canada

Interventions studied

Observation without surgeryStandard-of-care surgery

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Target enrolment

14 participants

Study type

INTERVENTIONAL

Phase

Phase 1

Status

Not yet recruiting

First posted

Dec 20, 2024

Last updated on the registry

Aug 14, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Lung Cancer