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NCT07486817

Beamion 44: A Study to Test How Well Zongertinib is Tolerated by People With Advanced Non-small Cell Lung Cancer With HER2 Mutations When Given in Combination With Chemotherapy With or Without Pembrolizumab

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 9 versions: 9 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 15 words
    • Primary endpoints: details revised at 1 of 1 entry
    • Trial sites expanded: 17 → 20 locations
    • Secondary endpoints: details revised at 2 of 10 entries
  2. Site details revised at 2 of 17 sitesv8
  3. Site details revised at 2 of 17 sitesv7
  4. Site details revised at 2 of 17 sitesv6
  5. Site details revised at 8 of 17 sitesv5
  6. Site details revised at 1 of 17 sitesv4
  7. Recruitment opened
    • Start date changed from estimate of Jun 22, 2026 to Jun 4, 2026
    • Site details revised at 17 of 17 sites
    v3
  8. Start date: May 8, 2026 to Jun 22, 2026
    • Study sites revised (17)
    v2
  9. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Occurrence of discontinuation and/or prolonged interruption (>7 days) of zongertinib due to treatment-related adverse events (AEs) in the first 2 cycles of treatment
Timeframe: up to 6 weeks

Secondary (10)

Occurrence of serious adverse events (SAE) during the on-treatment period
Occurrence of dose reduction of zongertinib
Occurrence of discontinuation and/or prolonged interruption (>7 days) of zongertinib due to treatment-related AEs during the on-treatment period
Occurrence of Grade ≥3 non-hematological AE during the on-treatment period
Occurrence of combination limiting toxicities (CLTs) during the on-treatment period
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Objective response (OR) according to Response evaluation criteria in solid tumors (RECIST) 1.1 as assessed by the investigator
Time to OR, defined as the time from date of randomization to first documented confirmed CR or PR among patients with OR as determined by investigator assessment per RECIST 1.1
Duration of OR (DoR), defined as the time from first documented confirmed CR or PR until disease progression or death among patients with OR as determined by investigator assessment per RECIST 1.1
Progression-free survival (PFS), defined as the time from randomization until tumor progression according to RECIST 1.1 as assessed by the investigator, or death from any cause, whichever occurs earlier
Time on treatment (ToT), defined as the time from first dose of study treatment until zongertinib treatment discontinuation or death

Arms and interventions

Arm A: zongertinib + cisplatin or carboplatin and pemetrexedExperimental
Arm B: zongertinib + cisplatin or carboplatin and pemetrexed with pembrolizumabExperimental

Drugs: Zongertinib, Cisplatin, Carboplatin, Pemetrexed, Pembrolizumab

Sites

20 sites in 8 countries

Australia 3, South Korea 3, Spain 3, United Kingdom 3, China 2, France 2, Germany 2, Japan 2