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Randomized phase II trial of Cemiplimab plus OSE2101 (TEDOPI®) as maintenance therapy in ctDNA positive NSCLC.
EU CTIS ID: 2024-519262-42-00
What this study is testing
to determine ctDNA clearance in TEDOPI plus cemiplimab versus cemiplimab +\- pemetrexed (standard maintenance arm) in patients with HLA-A2 positive NSCLC not progressing after 4 cycles of chemoimmunotherapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 chemoimmunotherapy irrespective of PD-L1 levels
- HLA-A2 positive
- ECOG PS 0-1
- Signed informed consent (IC) prior to any trial-specific procedures.
You likely can't join if
- Patients not candidate for chemoimmunotherapy
- 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)
See the full eligibility 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 chemoimmunotherapy irrespective of PD-L1 levels
- HLA-A2 positive
- ECOG PS 0-1
- Signed informed consent (IC) prior to any trial-specific procedures.
- Patients not candidate for chemoimmunotherapy
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.