Phase II clinical trial with an adaptive design according to response to cemiplimab monotherapy using ctDNA and subsequent treatment with chemotherapy (CT) and cemiplimab or cemiplimab monotherapy in first line advanced NSCLC patients. PALACE GECP 22/01

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518812-38-00

Acronym

PALACE _GECP 22/01

Enrollment

Registered

2025-03-26

Start date

2025-07-02

Completion date

Unknown

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer (NSCLC)

Brief summary

OS at 24 months in the intention to treat (ITT) population

Detailed description

1. Duration of response (DOR), 2. Overall survival (OS) at 12, 36 and 48 months, 3. Progression free survival (PFS) at 12, 24, 36 and 48 months, 4. Sites of first failure, 5. Overall response rate (ORR), 6. Toxicity profile

Interventions

DRUGPaclitaxel Teva 6 mg/ml concentrado para solución para perfusión EFG

DRUGPemetrexed Stadagen 25 mg/ml concentrado para solución para perfusion

DRUGLIBTAYO 350 mg concentrate for solution for infusion.

DRUGCarboplatino Teva 10 mg/ml Concentrado para solución para perfusión

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
OS at 24 months in the intention to treat (ITT) population	—

Secondary

Measure	Time frame
1. Duration of response (DOR), 2. Overall survival (OS) at 12, 36 and 48 months, 3. Progression free survival (PFS) at 12, 24, 36 and 48 months, 4. Sites of first failure, 5. Overall response rate (ORR), 6. Toxicity profile	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026