Perioperative Cemiplimab for Resectable Non-Small Cell Lung Cancer With High PD-L1
ConditionLung Cancer (NSCLC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHenry Ford Health System
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Patients showing evidence of any distant metastases during screening.
Patients with tumors with known actionable EGFR gene mutations, ALK, RET or ROS1 gene translocations
Any condition that requires ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study medication. Participants who require a brief course of steroids (up to 2 days in the week before enrollment) or physiologic replacement are not excluded.
Significant renal or hepatic impairment.
Trial design
Treatments tested in this trial
- Cemiplimab
- Adjuvant chemotherapy
Treatment groups
33 Participants
are divided into 1 treatment groupLocations
1Henry Ford Health48202, DetroitMichigan, United States
Sponsors and collaborators
Henry Ford Health System
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
Source ClinicalTrials.gov