PALACE: Cemiplimab Trial According to ctDNA Levels

Sponsor
Fundación GECP
Study ID
NCT06917573
Phase
PHASE2
Status
Recruiting
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Conditions

  • Lung Diseases
  • Non Small Cell Lung Cancer Metastatic
  • Respiratory Tract Neoplasms
  • Stage III Non-small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Thoracic Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    Patients 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 — DRUG
    Patients 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 — DRUG
    Patients 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.

Study Details

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.

Key Dates

Start date
Jul 29, 2025
Status verified
Nov 2025
Primary completion
Dec 30, 2031
Completion
Dec 30, 2031

Study Design

Enrollment
63 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    A. Cemiplimab monotherapy \- Cemiplimab Cemiplimab will be administered in monotherapy for 2 cycles. After 2 cycles of treatment and after response evaluation according to RECIST criteria and ctDNA quantification, patient will receive cemiplimab + chemotherapy or continue treatment with cemiplimab monotherapy Cemiplimab monotherapy will be administered until disease progression, unacceptable toxicity, loss of clinical benefit as judged by the investigator or up to a maximum of 2 years of treatment. B. Cemiplimab + chemotherapy The treatment with chemotherapy will be selected according to investigator's choice. Carboplatin and Pemetrexed or Carboplatin plus taxanes is recommended.

Primary Outcome Measure

To determine whether therapy decision making based on ctDNA analysis improves overall survival [ Time Frame: From the date of the end of two cycles of Cemiplimab treatment until 24 months ]

Central Contacts

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