Actively Recruiting
A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study.
Led by Fondazione Ricerca Traslazionale · Updated on 2025-12-04
160
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed diagnosis of advanced, locally advanced (not suitable for definitive chemoradiation), or metastatic non-small-cell lung cancer (NSCLC) without oncogene addiction
- Candidate for first-line chemo-immunotherapy regardless of PD-L1 levels
- Positive for HLA-A2
- ECOG performance status 0 or 1
- Signed informed consent before any trial-specific procedures
You will not qualify if you...
- Not a candidate for chemo-immunotherapy
- Negative for HLA-A2
- Symptomatic or untreated and unstable brain metastases; asymptomatic or pretreated brain metastases allowed
- Tumor tissue not available from archive or collected before trial inclusion
- Presence of EGFR mutations or ALK or ROS1 rearrangements
- ECOG performance status greater than 1
- Diagnosis of another cancer within the last 3 years, except for in situ carcinoma of cervix, breast, bladder, or skin carcinoma (squamous or basaloid)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Istituti Fisioterapici Ospitalieri- Ifo - Istituto Regina Elena
Roma, RM, Italy, 00144
Actively Recruiting
Research Team
F
Federico Cappuzzo, Medical Oncology
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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