Combining BNT327 with chemotherapy for treating 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 Phase 2/3 clinical trial evaluates the safety and effectiveness of BNT327, a bispecific antibody, in combination with standard chemotherapy and other investigational agents for patients with first-line non-small cell lung cancer (NSCLC). The study is divided into two substudies based on histological subtypes, with participants randomized to receive different dose levels of BNT327 plus chemotherapy. An internal review committee will assess the Phase 2 data to determine the appropriate dose for the Phase 3 part of the study, which will also involve an independent data monitoring committee for oversight.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Have systemic treatment naive, histologically or cytologically confirmed diagnosis of Stage IIIB or IIIC (who are not amenable to curative surgery or radiotherapy) or Stage IV NSCLC per the Union Internationale contre le Cancer/American Joint Committee on Cancer staging system, 9th edition.
* Have at least one measurable lesion as the targeted lesion based on RECIST v1.1. Lesions treated after prior local treatment (radiotherapy, ablation, interventional procedures, etc.) are generally not considered as target lesions. If the lesion with prior local treatment is the only targeted lesion, evidence-based radiology must be provided to demonstrate disease progression (the single bone metastasis or the single central nervous system metastasis should not be considered as a measurable lesion).
* Eastern Cooperative Oncology Group Performance Status of 0 or 1.
* Adequate organ function as defined in the protocol.

Key Exclusion Criteria:

* Have histologically or cytologically confirmed NSCLC with small-cell lung cancer or neuroendocrine histologic component.
* Have received any of the following therapies or drugs within the noted time intervals prior to study treatment:

  * Previous chemotherapy (platinum-based) or PD(L)-1 for treating NSCLC in either neoadjuvant/adjuvant or locally advanced/metastatic setting.
  * Participants who received prior treatment with anti-VEGF monoclonal antibody, or PD(L)-1/VEGF bispecific antibody.
  * Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 7 days prior to the initiation of study treatment. Note: local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short-term use (\<=7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens) are allowed.
* Have uncontrolled hypertension or poorly controlled diabetic conditions prior to study treatment.
* Have a serious or non-healing wound, or (incompletely healed) bone fracture. This includes history (within 6 months prior to study entry) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing fistula/perforation.
* Participants with significant risk of hemorrhage (per investigator clinical judgment).
* Participants have superior vena cava syndrome or symptoms of spinal cord compression.

NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Where it's running

• Birmingham Hematology and Oncology Associates LLC d/b/a Alabama Oncology
  Birmingham, Alabama, United States Recruiting
• Alaska Oncology and Hematology, LLC
  Anchorage, Alaska, United States Recruiting
• John Muir Clinical Research Center
  Concord, California, United States Recruiting
• University Of California - San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• Vail Health
  Vail, Colorado, United States Recruiting
• MedStar Georgetown-MedStar Georgetown Transplant Institute University Hospital (MGUH)
  Washington D.C., District of Columbia, United States Recruiting

+316 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.