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Recruiting Phase 1Phase 2 Interventional

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)

ClinicalTrials.gov ID: NCT07111520

Public ClinicalTrials.gov record NCT07111520. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 12:12 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase Ib/II, 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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT07111520
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
BioNTech SE
Industry
Enrollment
880 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 21, 2025
Primary completion
Oct 31, 2028
Completion
May 31, 2030
Last update posted
Aug 4, 2026

2025 – 2030

United States locations

U.S. sites
11
U.S. states
10
U.S. cities
11
Facility City State ZIP Site status
UCLA Hematology Oncology - Main Site Los Angeles California 90095 Recruiting
Stanford Cancer Institute Stanford California 94305 Recruiting
Yale University New Haven Connecticut 06511 Recruiting
Georgetown University - Lombardi Comprehensive Cancer Center Washington D.C. District of Columbia 20007 Recruiting
Moffit Cancer Center Tampa Florida 33612 Recruiting
Dana-Farber Cancer Institute Boston Massachusetts 02215 Recruiting
Henry Ford Health System Detroit Michigan 48202 Recruiting
Memorial Sloan Kettering Cancer Center New York New York 10065 Recruiting
Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center Cleveland Ohio 44195 Recruiting
University of Texas M. D. Anderson Cancer Center Houston Texas 77030 Recruiting
NEXT Virginia Fairfax Virginia 22031 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 74 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07111520, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 4, 2026 · Synced Sep 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07111520 live on ClinicalTrials.gov.

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