About this trial
This is an open-label, non-randomised, phase II, multicenter clinical trial. 63 stage IV or stage IIIB/C not candidates for definitive chemo/radiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer therapy will be enrolled in this trial to determine whether therapy decision making based on ctDNA analysis improves overall survival.
Eligibility criteria
Qualifiers
Histologically confirmed stage IV or stage IIIB/C not candidates for definitive chemo/radiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer therapy
PDL1 ≥50%
ECOG performance status 0-1
Patients aged ≥ 18 years
Disqualifiers
Patients whose tumors harbor an activating mutation in EGFR, ALK translocation, or ROS Proto-Oncogene 1 (ROS1) rearrangements sensitive to available targeted inhibitor therapy
Patients with grade ≥2 neuropathy
Pregnant or breastfeeding women
Patients with a weight loss >10% within the previous 3 months
Trial design
Treatments tested in this trial
- Cemiplimab
- Carboplatin
- Paclitaxel