PALACE: Cemiplimab Trial According to ctDNA Levels

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación GECP

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

Treatment groups

63 Participants
are divided into 1 treatment group

Sponsors and collaborators