A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer

Launched by BIONTECH SE · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new combination therapy for patients with advanced lung cancer. The treatment includes two investigational drugs: BNT324, which targets a specific protein on cancer cells, and BNT327, which helps stimulate the immune system to fight the cancer. The trial aims to see if this combination is effective and safe for patients with advanced or recurrent lung cancer, specifically small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC).

To join this study, participants need to be at least 18 years old and have a confirmed diagnosis of advanced lung cancer that cannot be surgically removed. They should also have measurable disease and a good performance status, meaning they can carry out daily activities with little to no difficulty. Participants who join the trial will be monitored closely for their health and how well the treatment works. It’s important to note that individuals who have had certain previous treatments for lung cancer may not be eligible. Overall, this trial represents a hopeful step towards finding new ways to treat advanced lung cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged ≥18 years at the time of giving informed consent.
• • Histological or cytological confirmed unresectable advanced/metastatic lung cancer. Histological classification may be based on tumor samples prior to metastatic disease. Participants with mixed histology must be classified based on the main component. Participants with NSCLC are eligible with any or no PD-L1 expression. Participants with AGA-positive disease must have received targeted therapy prior to enrollment in this study.
• • Part 1: Participants with NSCLC and SCLC
• • Part 2 Cohort 1: Participants with NSCLC (subpopulation 1) AGA negative, 1L
• • Part 2 Cohort 2: Participants with SCLC, 2L+
• • Part 2 Cohort 3: Participants with NSCLC (subpopulation 1) AGA negative, 2L+
• • Part 2 Cohort 4: Participants with NSCLC (subpopulation 2) AGA negative, 1L
• • Part 2 Cohort 5: Participants with NSCLC (subpopulation 2) AGA negative, 2L+
• • Part 2 Cohort 6: Participants with NSCLC AGA positive
• • Part 2 Cohort 7: Participants with SCLC, 1L
• • Have measurable disease defined by RECIST version 1.1.
• • Have an Eastern Cooperative Oncology Group performance status of 0 or 1.
• • Have a life expectancy of ≥12 weeks.
• Exclusion Criteria:
• • Prior treatment with B7-H3 targeted therapy.
• • Prior treatment with ADC with topoisomerase inhibitor (e.g., datopotamab deruxtecan, trastuzumab deruxtecan). Note: This exclusion applies to participants in the first-line/treatment-naïve cohorts in the advanced/metastatic setting. Prior treatment with ADC with topoisomerase inhibitor payload is only allowed for participants in the second-line plus cohorts in the advanced/metastatic setting.
• • Is a candidate to locoregional treatment (including surgical resection, stereotactic radiotherapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as "radical" intent), per investigator's assessment.
• • Has a history of significant hematologic toxicity to prior lines of therapy, as assessed by investigator, e.g., Grade 4 febrile neutropenia or recurrent/persistent Grade 3 to 4 neutropenia.
• • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply to all or some participants depending on the cohort.