Phase II Trial of Perioperative Cemiplimab in Patients With Resectable Non-small Cell Lung Cancer and PD-L1 ≥50%
Henry Ford Health System
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the trial * Male or Female, aged 18 years or above * ECOG 0-1 * Patient diagnosed with early-stage resectable stage II to IIIA squamous or non-squamous, operable treatment naïve NSCLC with PD-L1 TPS ≥50%. Patients who are eligible for standard of care treatment are allowed as well as those who are ineligible for chemo, if they fit the rest of the criteria * PD-L1 TPS ≥50% as assessed by DAKO 22C3 assay * Adequate bone marrow function, as determined by hematological parameters: 1. ANC ≥1.5 x…
Interventions
- DrugCemiplimab
Cemiplimab 350 mg IV every 3 weeks for 3 neoadjuvant cycles, followed by surgical resection, then 10 adjuvant cycles of cemiplimab at the same dose and schedule.
- DrugAdjuvant chemotherapy
Up to 4 cycles of histology-matched platinum-based adjuvant chemotherapy may be administered after surgery, at the treating oncologist's discretion, prior to starting adjuvant cemiplimab.
Location
- Henry Ford HealthDetroit, Michigan