A Randomized phase II trial of Cemiplimab plus OSE2101 (TEDOPI®) as maintenance therapy in ctDNA positive NSCL. The Cemited study.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519262-42-00

Enrollment

Registered

2025-04-17

Start date

2025-07-15

Completion date

Unknown

Last updated

2025-08-13

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

Conditions

NSCLC non-small cell lung cancer

Brief summary

Differences in ctDNA clearance rate in the two arms of treatment

Detailed description

- Overall Survival - Progression Free Survival according to RECSIT 1:1 - Overall Response Rate (ORR) according to RECSIT 1:1 --- Incidence of any grade Adverse Events measured according to NCI-CTCAE (v. 5.0) Levels of other biomarkers (including PD-L1 and TMB) during the treatments and statistical associations with other outcome measures

Interventions

DRUGArmisarte 25 mg/ml concentrate for solution for infusion

DRUGLIBTAYO 350 mg concentrate for solution for infusion.

DRUGTEDOPI

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Differences in ctDNA clearance rate in the two arms of treatment	—

Secondary

Measure	Time frame
- Overall Survival - Progression Free Survival according to RECSIT 1:1 - Overall Response Rate (ORR) according to RECSIT 1:1 --- Incidence of any grade Adverse Events measured according to NCI-CTCAE (v. 5.0) Levels of other biomarkers (including PD-L1 and TMB) during the treatments and statistical associations with other outcome measures	—

Countries

Italy

Outcome results

None listed

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