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

Recruiting now · Phase 2

Conditions studied: NSCLC

In brief

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.

Key facts

Study ID

NCT07264673

Run by

Fondazione Ricerca Traslazionale

People needed

160

Starts

2025-04-17

Expected to finish

2029-10-01

Last updated by the study team

2025-12-04

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Istituti Fisioterapici Ospitalieri- Ifo - Istituto Regina Elena — Roma, RM, Italy (enrolling)

Full record on ClinicalTrials.gov

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