BNT327-01 - Study of BNT327 for pts with SCLC w/ chemo
Research type
Research Study
Full title
A Phase II, multi-site, open-label, parallel group trial of BNT327 in combination with chemotherapy for participants with untreated extensive-stage small-cell lung cancer and participants with previously treated small-cell lung cancer
IRAS ID
1010045
Contact name
Lynsey Kennedy
Contact email
Sponsor organisation
BioNTech SE
Clinicaltrials.gov Identifier
NCT06449209
Research summary
The main purpose of this clinical research study is to look at how safe and well tolerated the study drug (called BNT327) in combination with chemotherapy is and whether it helps to prevent untreated extensive-stage small-cell lung cancer or a previously treated small-cell lung cancer from getting worse. The study drug is designed to block the function of proteins that lower the body's ability to fight infection and disease, to reduce blood vessel growth in a tumour (and thus reduce tumour growth) and reduce or stop tumour growth and spreading.
Approximately 70 to 100 participants will be recruited globally.
Following informed consent and depending on the treatment group a participant is assigned to, after the screening visit (spread over up to 21 days), there will be two or three periods: treatment and follow-up, or treatment, maintenance and follow-up, respectively. The treatment period (including maintenance period) will last up to 2 years with the follow-up period lasting up to 1 year. Participants will know which treatment group they are assigned.
The participant will undergo: collection of demographics and medical history, physical examination, vital signs, weight and height, blood tests (for safety and pregnancy testing), urine and stool tests, ECGs, ECHOs, tumour imaging and assessments, archival tumour tissue testing (if available), questionnaires and performance assessments.
The possible risks or discomforts from taking part in this study may include: increased blood pressure, elevated protein in the urine, immune-related side effects, intestinal perforation, bleeding, delayed wound healing, bruising, or infection at the sites of treatment infusion/blood collection.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
24/NW/0179
Date of REC Opinion
23 Jul 2024
REC opinion
Further Information Favourable Opinion