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)

Part of paid clinical trials in Los Angeles, California.

Sponsor
BioNTech SE
Study ID
NCT07111520
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BNT326 — DRUG
    intravenous (IV) infusion
  • Pumitamig — DRUG
    IV infusion

Study Details

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.

Key Dates

First listed
Aug 8, 2025
Start date
Sep 22, 2025
Status verified
Aug 2026
Primary completion
Nov 30, 2028
Completion
Jun 30, 2030

Study Design

Enrollment
880 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 - BNT326 (DL1) + pumitamig (DL1)
    Combination therapy of BNT326 and pumitamig, starting dose. In participants with second-line (or higher) 2L(+), squamous or non-squamous NSCLC, actionable genomic alterations (AGA)-negative/positive, any programmed death-ligand 1 (PD-L1).
  • Experimental: Part 1 - BNT326 (DL2) + pumitamig (DL1)
    Combination therapy of BNT326 and pumitamig. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.
  • Experimental: Part 1 - BNT326 (DL3) + pumitamig (DL1)
    Combination therapy of BNT326 and pumitamig. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.
  • Experimental: Part 1 - BNT326 (DL1) + pumitamig (DL2)
    Combination therapy of BNT326 and pumitamig. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.
  • Experimental: Part 1 - BNT326 (DL2) + pumitamig (DL2)
    Combination therapy of BNT326 and pumitamig. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.
  • Experimental: Part 1 - BNT326 (DL3) + pumitamig (DL2)
    Combination therapy of BNT326 and pumitamig. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.
  • Experimental: Part 2a (Cohort A, Arm 1) - BNT326 (DL1) + pumitamig (DL1)
    Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.
  • Experimental: Part 2a (Cohort A, Arm 2) - BNT326 (DL2) + pumitamig (DL1)
    Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.
  • Experimental: Part 2a (Cohort A, Arm 3) - BNT326 (DL3) + pumitamig (DL1)
    Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.
  • Experimental: Part 2a (Cohort A, Arm 4) - BNT326 (DL1) + pumitamig (DL2)
    Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.
  • Experimental: Part 2a (Cohort A, Arm 5) - BNT326 (DL2) + pumitamig (DL2)
    Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.
  • Experimental: Part 2a (Cohort A, Arm 6) - BNT326 (DL3) + pumitamig (DL2)
    Combination therapy of BNT326 and pumitamig. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.
  • Experimental: Part 2a (Cohort B, Arm 1) - BNT326 (DL1) + pumitamig (DL1)
    Combination therapy of BNT326 and pumitamig. In participants with first-line (1L) squamous or non-squamous NSCLC, AGA-negative, any PD-L1.
  • Experimental: Part 2a (Cohort B, Arm 2) - BNT326 (DL2) + pumitamig (DL1)
    Combination therapy of BNT326 and pumitamig. In participants with 1L squamous or non-squamous NSCLC, AGA-negative, any PD-L1.
  • Experimental: Part 2a (Cohort B, Arm 3) - BNT326 (DL3) + pumitamig (DL1)
    Combination therapy of BNT326 and pumitamig. In participants with 1L squamous or non-squamous NSCLC, AGA-negative, any PD-L1.
  • Experimental: Part 2a (Cohort B, Arm 4) - BNT326 (DL1) + pumitamig (DL2)
    Combination therapy of BNT326 and pumitamig. In participants with 1L squamous or non-squamous NSCLC, AGA-negative, any PD-L1.
  • Experimental: Part 2a (Cohort B, Arm 5) - BNT326 (DL2) + pumitamig (DL2)
    Combination therapy of BNT326 and pumitamig. In participants with 1L squamous or non-squamous NSCLC, AGA-negative, any PD-L1.
  • Experimental: Part 2a (Cohort B, Arm 6) - BNT326 (DL3) + pumitamig (DL2)
    Combination therapy of BNT326 and pumitamig. In participants with 1L squamous or non-squamous NSCLC, AGA-negative, any PD-L1.
  • Experimental: Part 2b (Cohort C, Arm 1) - BNT326 + pumitamig
    Combination therapy of BNT326 and pumitamig. In participants with 2L+, squamous or non-squamous NSCLC, AGA-negative or epithelial growth factor receptor (EGFR) activating mutation, any PD-L1. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a.
  • Experimental: Part 2b (Cohort C, Arm 2) - BNT326 + pumitamig
    Combination therapy of BNT326 and pumitamig. In participants with 2L+, squamous or non-squamous NSCLC, AGA-negative or EGFR activating mutation, any PD-L1. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a.
  • Experimental: Part 2b (Cohort D1, Arm 1) - BNT326 + pumitamig
    Combination therapy of BNT326 and pumitamig. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 ≥50%. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a.
  • Experimental: Part 2b (Cohort D1, Arm 2) - BNT326 + pumitamig
    Combination therapy of BNT326 and pumitamig. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 ≥50%. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a.
  • Experimental: Part 2b (Cohort D1, Arm 3) - Pumitamig monotherapy
    Pumitamig monotherapy. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 ≥50%. DL used will be determined by the IRC based on data generated from Part 1 and Part 2a.
  • Experimental: Part 2b (Cohort D2, Arm 1) - BNT326 + pumitamig
    Combination therapy of BNT326 and pumitamig. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 \<50%. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a.
  • Experimental: Part 2b (Cohort D2, Arm 2) - BNT326 + pumitamig
    Combination therapy of BNT326 and pumitamig. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 \<50%. DLs used will be determined by the IRC based on data generated from Part 1 and Part 2a.

Primary Outcome Measure

Part 1 - Occurrence of dose limiting toxicities (DLTs) within a participant [ Time Frame: 21 days starting on Day 1 of Cycle 1 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
UCLA Hematology Oncology - Main SiteLos AngelesCalifornia90095-
Stanford Cancer InstituteStanfordCalifornia94305-
Yale UniversityNew HavenConnecticut06511-
Georgetown University - Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007-
Moffit Cancer CenterTampaFlorida33612-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Henry Ford Health SystemDetroitMichigan48202-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer CenterClevelandOhio44195-
University of Texas M. D. Anderson Cancer CenterHoustonTexas77030-
NEXT VirginiaFairfaxVirginia22031-

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