What is this study testing for people with advanced non-small cell lung cancer?

This study is testing the combination of two investigational drugs, BNT326 and BNT327, to evaluate their safety, tolerability, and preliminary effectiveness in adults with advanced or metastatic NSCLC. Researchers want to identify safe dose levels and understand how well this combination works compared to other treatments. The trial is sponsored by BioNTech SE.

Who may be eligible for this advanced non-small cell lung cancer clinical trial?

Adults aged 18 or older with confirmed advanced or metastatic NSCLC may be eligible. Participants must have measurable disease, good performance status, and be able to provide tumor tissue samples. Some participants may have received prior treatments while others may be treatment-naefve. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced non-small cell lung cancer clinical trial?

Study-related care, including the investigational drugs and all trial visits, is provided at no cost. However, personal travel and related expenses are not guaranteed to be covered and may vary depending on the participant's situation.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID07111520

A Phase IbII, Multi-site, Open-label, Dose Finding Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of BNT326 in Combination With BNT327 in Participants With Advanced Non-small Cell Lung Cancer NSCLC

Led by BioNTech SE · Updated on 2026-05-05

420

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the combination of two investigational drugs, BNT326 and BNT327, in adults with advanced or metastatic non-small cell lung cancer NSCLC that has either relapsed, progressed, or is treatment-naefve. The study aims to find safe dosage levels and assess the safety, preliminary efficacy, and tolerability of this combination therapy. It involves participants with histologically or cytologically confirmed NSCLC without curative treatment options. The trial has several parts Part 1 focuses on dose escalation to establish safe dose levels of BNT326 combined with BNT327. Part 2a expands to evaluate preliminary effectiveness and safety, enrolling participants with different treatment histories. Part 2b involves dose optimization and compares treatments in randomized cohorts. Participants receive intravenous infusions of the study drugs and may also receive pembrolizumab or standard chemotherapy depending on their cohort. Dosing decisions for later cohorts are based on earlier study data. Participants will go through screening, treatment, safety follow-up, efficacy follow-up, and long-term survival follow-up periods. Treatments continue until disease progression, unacceptable side effects, withdrawal, study end, or a maximum of 24 months. Researchers will monitor dose-limiting toxicities, adverse events, treatment responses, progression-free survival, and overall survival over about 36 months. Blood samples will be collected for pharmacokinetic and antibody assessments. Participants health and disease status will be regularly assessed by imaging and clinical evaluations throughout the study.

CONDITIONS

Brief Title

A Clinical Trial to Test if an Investigational Combination Therapy With BNT326 and BNT327 is Safe and Potentially Beneficial for People With Advanced Non-small Cell Lung Cancer (NSCLC)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older at the time of informed consent
Measurable disease defined by RECIST v1.1
Ability to provide tumor tissue sample from archival tissue or fresh biopsy unless medically unjustifiable
Eastern Cooperative Oncology Group performance status of 0 or 1
Adequate organ and bone marrow function within 7 days before enrollment
Advanced (metastatic or locally recurrent without curative intent) non-squamous or squamous NSCLC (all cohorts) or only non-squamous NSCLC (Cohort D2)
Specific cohort criteria including prior treatment lines, actionable genomic alterations, and PD-L1 status as detailed in the protocol
For patients with EGFR activating mutation: prior EGFR TKI treatments as specified and progression or intolerance to prior therapies

You will not qualify if you...

Disease progression on or intolerance to prior HER3-targeting agents or topoisomerase I inhibitor payloads (with some exceptions in Part 2a Cohort A)
Uncontrolled illnesses that increase risk or limit study compliance including bleeding, active infections, severe liver cirrhosis, significant pulmonary disease, oncologic emergencies, psychiatric or abuse conditions, and recent severe colitis
Left ventricular ejection fraction below 50%
Clinically uncontrolled pleural, pericardial effusions, or ascites requiring intervention within 2 weeks before enrollment
History or current interstitial lung disease or pneumonitis requiring steroids, or suspected ILD/pneumonitis not ruled out by imaging
Recent exposure to protocol-specific treatments without required washout
Pregnancy, breastfeeding, planned pregnancy, or fertile males planning conception during study or within protocol timeframes
Participation in other investigational studies requiring exclusion periods
History of small bowel obstruction requiring hospitalization in past 3 months
Significant proteinuria as defined in protocol
History of severe immune-related adverse events leading to prior treatment discontinuation
Clinically active, untreated, or symptomatic central nervous system metastases
Significant hemorrhage risk or coagulation disorders
Active or chronic corneal disorders preventing adequate monitoring of drug-induced eye effects
Other protocol-defined criteria may apply

Research Team

BioNTech clinical trials patient information

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