Investigating a new combination therapy for advanced lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the efficacy and safety of a combination therapy using BNT324, a B7-H3 antibody-drug conjugate, and BNT327, a bispecific antibody targeting PD-L1 and VEGF, in patients with advanced lung cancer. The study is divided into two parts: the first part focuses on establishing safe dosage levels through a dose escalation design, while the second part aims to confirm the clinical efficacy of the optimal dose in specific lung cancer cohorts. Participants will undergo a screening period, treatment, safety follow-up, and long-term survival follow-up.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mayo Clinic Arizona
  Phoenix, Arizona, United States Recruiting
• Precision NextGen Oncology and Research Center
  Beverly Hills, California, United States Recruiting
• Cedars Sinai Medical Center
  Los Angeles, California, United States Recruiting
• UCLA - David Geffen School of Medicine
  Santa Monica, California, United States Recruiting
• University of Colorado Cancer Center
  Aurora, Colorado, United States Recruiting
• Mayo Clinic in Florida
  Jacksonville, Florida, United States Recruiting

+41 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BioNTech clinical trials patient information
• Email: patients@biontech.de
• Phone: +49 6131 9084

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.