Perioperative Cemiplimab for Resectable Non-Small Cell Lung Cancer With High PD-L1 (NCT07450183) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Perioperative Cemiplimab for Resectable Non-Small Cell Lung Cancer With High PD-L1
United States33 participantsStarted 2026-06-01
Plain-language summary
This is a single arm phase II trial enrolling patients with stage II-IIIA non-small cell lung cancer whose disease is deemed amenable for surgical resection and has a PD-L1 level of ≥50%. Patients will receive cemiplimab for 3 cycles followed by surgical resection. The primary endpoint evaluated by the study is the amount of residual tumor in the resected tissue after 3 cycles of cemiplimab. After surgery, all patients will receive additional 10 cycles of cemiplimab and the treating oncologist will decide on the need of administering chemotherapy prior to that.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. ANC ≥1.5 x 10\^9/L (1500/mm3)
✓. Hemoglobin ≥9.0 g/dL (5.59 mmol/L).
✓. Platelet count ≥75,000/mm³
✓. AST/ALT for adults: AST ≤3x ULN, ALT ≤3x ULN
✓. Serum bilirubin ≤1.5x ULN, except in patients with clinically documented Gilbert's Syndrome where ≤3x the ULN is permitted
Exclusion criteria
✕. Stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening;
✕. Vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); and/or
✕. Sexual abstinence†,‡. Pregnancy testing and contraception are required for WOCBP. Pregnancy testing and contraception are not required for women who are postmenopausal or permanently sterile.