BNT327-07 - Ph2 trial of BNT327 for NSCLC w chemo following chemoimmunotherapy
Research type
Research Study
Full title
A Phase II, multisite, open-label, single arm trial of BNT327 in combination with docetaxel in second-line stage IV non-small cell lung cancer (NSCLC) following chemoimmunotherapy
IRAS ID
1010972
Contact name
Catrine Schulz-Eying
Contact email
Sponsor organisation
BioNTech SE
Clinicaltrials.gov Identifier
Research summary
This study is looking at a new drug BNT327 for non-small cell lung cancer, when used in combination with docetaxel. Docetaxel is already approved for use in lung cancer. This study aims to understand how safe BNT327 is when given alongside docetaxel, and whether it helps to shrink lung cancer. There are two parts to this study; Part 1 and Part 2. Part 1 will help determine the safest dose for BNT327. In Part 1, participants will be placed in Group A or Group B. Group A will receive BNT327 at 1400mg, with docetaxel. The results from Group A will decide if Group B can receive BNT327 at 2000mg, with docetaxel. Part 2 will take place once the safest dose for BNT327 is determined in Part 1. Participants in Part 2 will take 2000mg with docetaxel. The first study participant will be invited to join Part 1 of the study. If you join the study later, then it will be Part 2 of the study. When you first join the study, you will sign a consent form. You will then enter the Screening Period. During this time, the study team will collect information about you such as your age, gender, ethnicity and medical history. The screening period will determine if you can participate. If you can, you will move into the treatment period. During the treatment period, you will receive BNT327 with docetaxel in 21-day cycles of treatment. You will receive the BNT327 with docetaxel for up to 2 years. During this time, you will also need to provide blood samples, urine samples, scans of your body to visualise your tumour and undergo physical examinations. After this, you will receive follow up visits. Some of these will be face to face and some will be telephone or video calls. Your participation is entirely voluntary, and you may leave the study at any time. The study doctor could also withdraw you from the study if they feel it is no longer safe for you take part and would discuss this with you.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
25/EM/0071
Date of REC Opinion
29 Apr 2025
REC opinion
Further Information Favourable Opinion