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A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)

Study acronym: SOHO-02
StatusRecruiting
PhasePhase 3
SponsorBayer
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment increased: 444 → 555 participants Eligibility criteria expanded, about 15 words · Secondary endpoints: details revised at 1 of 16 entries · Study sites revised (279) Show 3 more changesShow less
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 16 entries
    • Study sites revised (279)
  2. Trial sites expanded: 270 → 279 locationsv28
  3. Trial sites reduced: 285 → 270 locationsv27
  4. Study sites revised (285)v26 See this version in full on ClinicalTrials.gov ↗
  5. Study sites: 284 to 285v25
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 283 to 284v24
  2. Study sites revised (283)v23 See this version in full on ClinicalTrials.gov ↗
  1. Enrollment increased: 278 → 444 participants Interventions: BAY2927088 (Drug), Carboplatin (Drug), Cisplatin (Drug), Pembrolizumab (Drug), Pemetrexed (Drug) to Carboplatin (Drug), Cisplatin (Drug), Pembrolizumab (Drug), Pemetrexed (Drug), Sevabertinib (Drug) · Study sites revised (283) · Study title shortened, about 2 wordsv22 Show 3 more changesShow less
    • Interventions: BAY2927088 (Drug), Carboplatin (Drug), Cisplatin (Drug), Pembrolizumab (Drug), Pemetrexed (Drug) to Carboplatin (Drug), Cisplatin (Drug), Pembrolizumab (Drug), Pemetrexed (Drug), Sevabertinib (Drug)
    • Study sites revised (283)
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 280 to 283v21
  3. Study sites revised (280)v20 See this version in full on ClinicalTrials.gov ↗
  4. Primary completion date: Apr 26, 2027 to Oct 28, 2027 Study sites: 279 to 280 · Completion date: Apr 26, 2029 to Jun 27, 2029v19 Show 2 more changesShow less
    • Study sites: 279 to 280
    • Completion date: Apr 26, 2029 to Jun 27, 2029
  5. Study sites revised (279)v18 See this version in full on ClinicalTrials.gov ↗
  6. Site details revised at 12 of 279 sitesv17
  7. Study sites revised (279)v16 See this version in full on ClinicalTrials.gov ↗
  8. Study sites: 277 to 279 Study title expanded, about 1 wordv15 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 272 to 277v14
  10. Study sites: 268 to 272 Secondary endpoints revised (16) · Eligibility criteria expanded, about 1 word · Study title shortened, about 2 wordsv13 Show 3 more changesShow less
    • Secondary endpoints revised (16)
    • Eligibility criteria expanded, about 1 word
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites: 264 to 268v12
  12. Study sites: 261 to 264 Completion date: May 15, 2028 to Apr 26, 2029v11 Show 1 more changeShow less
    • Completion date: May 15, 2028 to Apr 26, 2029
  13. Study sites: 260 to 261v10
  14. Primary completion date: Jun 2, 2026 to Apr 26, 2027 Study sites: 246 to 260 · Secondary endpoints: details revised at 1 of 16 entriesv9 Show 2 more changesShow less
    • Study sites: 246 to 260
    • Secondary endpoints: details revised at 1 of 16 entries
  15. Study sites: 243 to 246v8
  16. Study sites: 239 to 243v7
  17. Study sites: 236 to 239 Start date changed from estimate of Aug 22, 2024 to Aug 28, 2024v6 Show 1 more changeShow less
    • Start date changed from estimate of Aug 22, 2024 to Aug 28, 2024
  18. Trial status: Not Yet Recruiting to Recruiting Study sites: 234 to 236 · Start date: Jul 24, 2024 to Aug 22, 2024v5 Show 2 more changesShow less
    • Study sites: 234 to 236
    • Start date: Jul 24, 2024 to Aug 22, 2024
  19. Start date: Jun 24, 2024 to Jul 24, 2024 Study sites: 204 to 234v4 Show 1 more changeShow less
    • Study sites: 204 to 234
  20. Study sites: 197 to 204v3
  21. Study sites: 176 to 197v2
  22. 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.
Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes called human epidermal growth factor receptor 2 (HER2) mutations. Advanced NSCLC means lung cancer that has spread nearby or to other parts of the body or is unlikely to be controlled with current treatments. HER2 is a protein that helps cells to grow and divide. Sometimes, cancer cells have a damaged HER2 gene. This is called a mutation. This mutation can lead to an abnormal HER2 protein which may cause cancer cells to grow and divide too quickly. The study treatment, sevabertinib, is designed to block the mutated HER2 protein and may help slow or stop the cancer from growing. The main purpose of this study is to find out how well sevabertinib works and how safe it is, compared with standard treatment in participants with advanced NSCLC with a HER2 mutation. The study participants will receive one of the study treatments: * Sevabertinib as a tablet taken by mouth twice a day * Standard approved treatment for this condition given by infusion into a vein every 21 days Participants will continue their assigned treatment for as long as they benefit from it and do not experience severe side effects, or until they or their doctor decide to stop treatment. When a participant assigned to the standard treatment has their cancer gets worse, they may have the opportunity to switch to receive sevabertinib. This switch is called a crossover. Participants who switch to sevabertinib will continue this treatment until their disease gets worse again, they have side effects that are too severe, or they or their doctor decide to stop treatment. During the study, the research team will: * do scans such as CT, PET, MRI, or X-rays to check the cancer * Check the overall health of the participants by performing tests such as blood and urine tests and checking heart health using an electrocardiogram and echocardiogram. * do pregnancy tests when needed * ask how the participants are feeling and whether they have had any adverse events or other health problems An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatment.
Trial Details
NCT Number NCT06452277
Lead Sponsor Bayer
Conditions Advanced Non-small Cell Lung Cancer, HER2 Mutation
Enrollment 555 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov