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Clinical Trials in Italy / NCT07264673
Recruiting Phase 2

A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study.

NCT07264673 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Ricerca Traslazionale
Phase
Phase 2
Started
2025-04-17
Last updated
2025-12-04

Condition(s) studied

NSCLC

Investigational drug(s) / intervention(s)

Tedopi →Cemiplimab →

Tedopi: Cemiplimab + OSE2101 (TEDOPI®) (ARM B: experimental arm)

Cemiplimab: Cemiplimab +/-Pemetrexed (ARM A: standard arm)

Study summary

This is a phase II randomized study investigating whether a combination maintenance with Cemiplimab and OSE2101 (TEDOPI®) could increase ctDNA clearance rate versus standard maintenance therapy in HLA-A2 positive NSCLC patients not progressing after 4 cycles of chemo-immunotherapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of non- oncogene addicted advanced, locally advanced (not suitable for definitive chemoradiation therapy) or metastatic non-small-cell lung cancer (NSCLC) * Any patient candidate for first line chemo-immunotherapy irrespective of PD-L1 levels * HLA-A2 positive * ECOG PS 0-1 * Signed informed consent (IC) prior to any trial-specific procedures Exclusion Criteria: * Patients not candidate for chemo-immunotherapy * HLA-A2 negative * Symptomatic or not previously treated and not stable brain metastases. Brain metastases are allowed if asymptomatic or pretreated * Tumor tissue not available (archive or collected before trial inclusion) * Evidence of EGFR mutations or ALK or ROS1 rearrangements * Performance status \>1 (ECOG) * Diagnosis of another cancer in the last 3 years, except for in situ carcinoma of cervix, breast and bladder or skin carcinoma(squamous or basaloid)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Istituti Fisioterapici Ospitalieri- Ifo - Istituto Regina Elena Roma RM Recruiting

On this site

📄 Libtayo (cemiplimab) drug profile →

More Fondazione Ricerca Traslazionale trials in Italy

Neoadjuvant Chemo-immunotherapy for Stage III PD-L1 Positive Non-Small Cell Lung Cancer (NSCLC) Recruiting
Randomized Trial Comparing Standard of Care Versus Immune- Based Combination in Relapsed Stage III Non-small-cell Lung Cancer (NSCLC) Pretreated With Chemoradiotherapy and Durvalumab Recruiting
Atezolizumab Versus Atezolizumab Plus Bevacizumab as First Line in NSCLC Patients (BEAT) Active, not recruiting
Efficacy of Tedopi Plus Docetaxel or Tedopi Plus Nivolumab as Second-line Therapy in Metastatic Non-small-cell Lung Cancer Progressing After First-line Chemo-immunotherapy (Combi-TED) Active, not recruiting
Study Investigating Anti-drug Antibodies in NSCLC Patients Exposed to Checkpoint Inhibitors (IMB) Recruiting

Other trials for the same condition

Progel Platinum for Air Leak Reduction After VATS Lobectomy for NSCLC Recruiting
Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations Active, not recruiting
A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers Active, not recruiting
An Observational Study to Evaluate the Real-World Clinical Management and Outcomes of ALK-Positive Advanced NSCLC Participants Treated With Alectinib Active, not recruiting
Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07264673 on ClinicalTrials.gov ↗ ← All trials in Italy