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 Stanford, California.

Sponsor
BioNTech SE
Study ID
NCT07111520
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • BNT326 — DRUG
    intravenous (IV) infusion
  • BNT327 — DRUG
    IV infusion
  • Pembrolizumab — DRUG
    IV infusion
  • SoC — DRUG
    IV infusion. Combination chemotherapy (pemetrexed, paclitaxel, or carboplatin). Chemotherapy will be selected according to the indication.

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 BNT327 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).

Key Dates

Start date
Sep 22, 2025
Status verified
Apr 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2030

Study Design

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

Arms

  • Experimental: Part 1 - BNT326 (DL1, starting dose) + BNT327
    Combination therapy of BNT326 and BNT327. In participants with second-line (or higher) 2L(+), squamous or non-squamous NSCLC, actionable genomic alterations (AGA)-negative/positive, any PD-L1.
  • Experimental: Part 1 - BNT326 (DL2) + BNT327
    Combination therapy of BNT326 and BNT327. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.
  • Experimental: Part 1 - BNT326 (DL3, optional) + BNT327
    Combination therapy of BNT326 and BNT327. In participants with 2L(+), squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.
  • Experimental: Part 2a (Cohort A, Arm 1) - BNT326 (DL1) + BNT327
    Combination therapy of BNT326 and BNT327. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.
  • Experimental: Part 2a (Cohort A, Arm 2) - BNT326 (DL2) + BNT327
    Combination therapy of BNT326 and BNT327. In participants with 2L+ squamous or non-squamous NSCLC, AGA-negative/positive, any PD-L1.
  • Experimental: Part 2a (Cohort B, Arm 1) - BNT326 (DL1) + BNT327
    Combination therapy of BNT326 and BNT327. 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) + BNT327
    Combination therapy of BNT326 and BNT327. In participants with 1L squamous or non-squamous NSCLC, AGA-negative, any PD-L1.
  • Experimental: Part 2b (Cohort C, Arm 1) - BNT326 (DL1) + BNT327
    Combination therapy of BNT326 and BNT327. In participants with 2L+, squamous or non-squamous NSCLC, AGA-negative or epithelial growth factor receptor (EGFR) activating mutation, any PD-L1.
  • Experimental: Part 2b (Cohort C, Arm 2) - BNT326 (DL2) + BNT327
    Combination therapy of BNT326 and BNT327. In participants with 2L+, squamous or non-squamous NSCLC, AGA-negative or EGFR activating mutation, any PD-L1.
  • Experimental: Part 2b (Cohort C, Arm 3) - BNT326 monotherapy
    BNT326 monotherapy (DL2). In participants with 2L+, squamous or non-squamous NSCLC, AGA-negative or EGFR activating mutation, any PD-L1.
  • Experimental: Part 2b (Cohort D1, Arm 1) - BNT326 (DL2) + BNT327
    Combination therapy of BNT326 and BNT327. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 ≥50%.
  • Active Comparator: Part 2b (Cohort D1, Arm 2) - Pembrolizumab
    Pembrolizumab monotherapy. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 ≥50%.
  • Experimental: Part 2b (Cohort D1, Arm 3) - BNT327 monotherapy
    BNT327 monotherapy. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 ≥50%.
  • Experimental: Part 2b (Cohort D2, Arm 1) - BNT326 (DL2) + BNT327
    Combination therapy of BNT326 and BNT327. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 \<50%.
  • Active Comparator: Part 2b (Cohort D2, Arm 2) - SoC - Pembrolizumab + chemotherapy
    Combination therapy of pembrolizumab and chemotherapy. In participants with 1L, squamous or non-squamous NSCLC, AGA-negative, PD-L1 \<50%.

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 (9)

FacilityCityStateZIPSite coordinators
Stanford Cancer InstituteStanfordCalifornia94305-
Yale UniversityNew HavenConnecticut06511-
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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