Pembrolizumab as Neoadjuvant Therapy for Resectable Stage IA3 to IIA Non-Small Cell Lung Cancer (… (NCT04638582) | Clinical Trial Compass
TerminatedPhase 2
Pembrolizumab as Neoadjuvant Therapy for Resectable Stage IA3 to IIA Non-Small Cell Lung Cancer (NSCLC)
Stopped: Study was terminated due to low recruitment.
Canada6 participantsStarted 2022-08-28
Plain-language summary
This is a prospective, randomized, single-site, open-label Phase II trial of neoadjuvant pembrolizumab (3 cycles) followed by surgery, versus concomitant neoadjuvant pembrolizumab with platinum doublet chemotherapy (3 cycles) followed by surgery for participants with Stage IA3, IB and IIA non-small-cell lung cancer (NSCLC). Participants will be offered pembrolizumab (6 cycles), and standard of care adjuvant chemotherapy (4 cycles) if applicable.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
What they're measuring
1
ctDNA resolution
Timeframe: Up to 2 years
Trial details
NCT IDNCT04638582
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre