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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)

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment increased: 420 → 880 participants Trial sites expanded: 68 → 85 locations · Primary completion moved earlier from Jan 2029 to Nov 2028 · Completion pushed from Jan 2030 to Jun 2030 · 5 morev4 Show 8 more changesShow less
    • Trial sites expanded: 68 → 85 locations
    • Primary completion moved earlier from Jan 2029 to Nov 2028
    • Completion pushed from Jan 2030 to Jun 2030
    • Trial arms changed: 15 → 25
    • Interventions: BNT326 (Drug), BNT327 (Drug), Pembrolizumab (Drug), SoC (Drug) to BNT326 (Drug), Pumitamig (Drug)
    • Eligibility criteria expanded, about 109 words
    • Secondary endpoints revised (11)
    • Study description expanded, about 27 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 2 to 68v3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Sep 2025 to Sep 22, 2025 · Collaborators: 2 to 1v2 Show 3 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Sep 2025 to Sep 22, 2025
    • Collaborators: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07111520
Lead Sponsor BioNTech SE
Collaborators: MediLink Therapeutics (Suzhou) Co., Ltd.
Conditions Non-small Cell Lung Cancer
Enrollment 880 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov