✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
About This Trial
This is a multi-site, open-label, dose-finding study, consisting of Parts 1, 2a, and 2b to investigate the combination of BNT326 with pumitamig (also known as BNT327 or PM8002) in participants with relapsed, progressive as well as treatment-naïve, advanced/metastatic non-small cell lung cancer (NSCLC).
This study will enroll adult participants with histologically or cytologically confirmed NSCLC that is advanced (i.e., either metastatic or recurrent tumors with no known curative treatment available).
The main goals of this study are:
1. To find the best dose levels (DLs) for the combination of BNT326 and pumitamig.
2. To look at how well participants with advanced NSCLC tolerate the combination therapy (for example, which side effects participants experience and how severe they are).
3. To look at how well the combination therapy works to shrink the tumor in participants with advanced NSCLC.
Who Can Join?
Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified): * Aged ≥18 years at the time of giving informed consent. Local laws will be followed if the age of consent is older. * Have measurable disease defined by RECIST v1.1. * Have Eastern Cooperative Oncology Group performance status of 0 or 1. * Have adequate organ and bone marrow function within 7 days before randomization/enrollment as defined in the protocol. * Have advanced (i.e., metastatic or locally recurrent where local therapy with curative intent is not possible) non-squamous or squamous NSCLC. Cohort-specific inclusion criteria Part 1, 2L+, squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1 (NOTE: regimens used as neoadjuvant and/or adjuvant treatment may be considered as prior lines for advanced disease if relapse occurred within 6 months of the last dose.) * for AGA-negative NSCLC only: * Have no actionable genomic alterations, such as EGFR mutations,…
⚠ Always speak to your doctor before applying to any clinical trial.