Neoadjuvant Chemo-Cemiplimab for Clinical Stage I, 2-3.9cm, Non-Small Cell Lung Cancer
Medical University of South Carolina
Summary
The study will investigate the role of cemiplimab in combination with platinum doublet chemotherapy in stage I resectable non-small cell lung cancer (NSCLC). Sub-4cm NSCLC tumors are highly lethal malignancies, yet no therapies are used in these patients to improve chances of survival with surgery alone. Here will be examined the ability of 3 cycles of cemiplimab-chemotherapy to induce pathologic complete responses to treatment.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants must have histologically proven NSCLC, clinically staged cT1c or T2a, clinically node-negative (no bronchoscopy is required for screening) using AJCC 9th Edition. 2. Participants must have an SUVmax \>6.2 on standard of care staging PET scan, and/or biopsy histology must be consistent with moderate/poorly/or undifferentiated NSCLC. 3. Participants must have pulmonary function study capable of tolerating the proposed lung resection according to the surgeon. This will require post-operative predicted forced expiratory volume (FEV) 1 and diffusing capacity of…
Interventions
- DrugCemiplimab
administered at a dose of 350 mg as an intravenous infusion over 30 minutes
- DrugCarboplatin + Pemetrexed/Paclitaxel
every 21 days for three cycles if not using cisplatin
- DrugCisplatin
every 21 days for three cycles if not using carboplatin and pemetrexed/paclitaxel
Location
- Medical University of South Carolina Hollings Cancer CenterCharleston, South Carolina