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.
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
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
Single group
Cemiplimab
DrugPatients will receive Cemiplimab administered by IV infusion over 30 minutes every 28 days (Q3W) until disease progression, unacceptable toxicity, loss of clinical benefit as judged by the investigator or up to a maximum of 2 years of treatment. Structure: is a high affinity hinge-stabilized IgG4P human antibody to the PD-1receptor (PDCD1, CD279) that blocks PD 1/PD L1 mediated T cell inhibition. Binding of the PD-1 ligands PD-L1 and PD-L2, to the PD-1 receptor found on T cells, inhibits T-cell proliferation and cytokine production. Upregulation of PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Route of administration: Intravenous infusion.
Carboplatin
DrugPatients will receive Carboplatin administered by IV infusion for 2 cycles. Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) platin. Stability: 24 hours at ambient temperature in 5% glucose, glucosaline or physiologic saline. It is recommended not to dilute with chlorinated solutions since this could affect the carboplatin. Route of administration: Intravenous infusion.
Paclitaxel
DrugPatients will receive Paclitaxel administered by IV infusion for 2 cycles. Structure: A diterpene whose composition is: 5b, 20- epoxy-1, 2a, 4,7b, 10b, 13a-hexahidroxytax-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine. Stability: Concentrations of 0.3-1.2 mg/ml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more than 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC. Guidelines of Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.
To determine whether therapy decision making based on ctDNA analysis improves overall survival
Test whether the addition of chemotherapy in patients receiving Cemiplimab, based on the ctDNA levels after two cycles of Cemiplimab, improves overall survival (OS) at 24 months. OS defined as the time from enrolment to death from any cause.
To assess the efficacy of the treatment in terms of the Progression Free Survival (PFS) at 12 months
PFS defined as the time from enrollment to the first occurrence of disease progression or death from any cause as determined by the investigator according to RECIST v1.1
To evaluate the sites of first failure
To evaluate the sites of first relapse or progression
Duration of response (DOR)
To evaluate the efficacy of cemiplimab as measured by investigator. Assessed as duration of response (DOR) according to RECIST v1.1
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