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New treatment option for NSCLC
Official title A Randomized Phase II Trial of Cemiplimab Plus OSE2101 ( TEDOPI®) as Maintenance Therapy in ctDNA Positive NSCL. The Cemited Study.
ClinicalTrials.gov ID: NCT07264673
What this study is testing
What is Tedopi?
Tedopi is an investigational medicine, being studied as a potential treatment for nsclc.
Also referred to as Cemiplimab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Histologically or cytologically confirmed diagnosis of non- oncogene addicted advanced, locally advanced (not suitable for definitive chemoradiation...
- 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 likely can't join 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)
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 chemo-immunotherapy 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 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)
The study team makes the final eligibility decision.
Where it's taking place
- Roma, RM, Italy
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, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Roma, RM, Italy. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.