LuCa-MERIT-1
Research type
Research Study
Full title
LuCa-MERIT-1: First-in-human, open label, Phase I dose confirmation trial evaluating the safety, tolerability and preliminary efficacy of BNT116 alone and in combinations in patients with advanced non-small cell lung cancer.
IRAS ID
1008928
Contact name
Özlem Türeci
Contact email
Sponsor organisation
BioNTech SE
Eudract number
2021-004739-94
Clinicaltrials.gov Identifier
Research summary
Patients diagnosed with Stage III, non-small cell lung cancer (NSCLC) that cannot be surgically removed, or Stage IV NSCLC which has spread to other parts of the body, are invited to participate in a clinical trial to determine if a vaccine called BNT116 is safe and well tolerated when given alone, or in combination with other medicines (cemiplimab, docetaxel, or carboplatin and paclitaxel). If eligible, participants will be allocated to one of the following cohorts; 1A, 1B, 2, 3, 4, 5 or 6. Participants will first enter a screening period in which they will undergo a series of assessments to determine their eligibility including but not limited to collection of medical history, a full physical examination, collection of blood samples, ECG, and provision of an archived tissue sample (or fresh tumour biopsy if an archived sample is not available). Once the screen period is successfully completed, participants will enter the treatment period where BNT116 will be administered in cycles of 21 days. The duration of this period will depend on which cohort participants are allocated to. When the treatment period is complete, participants will enter the End of Treatment/Post Treatment follow up period. The number of follow ups will vary depending on which cohort participants are allocated to, and participants may be asked to return to site for some visits.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0405
Date of REC Opinion
28 Feb 2024
REC opinion
Further Information Favourable Opinion