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Study of Capmatinib in Indian Patients With MET Exon 14 Skipping Mutation Positive Advanced NSCLC.

StatusCompleted
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Results posted: Oct 2, 2026 Primary endpoints revised (3) · Eligibility criteria expanded, about 72 words · Secondary endpoints revised (6) · 2 more Show 5 more changesShow less
    • Primary endpoints revised (3)
    • Eligibility criteria expanded, about 72 words
    • Secondary endpoints revised (6)
    • Study description expanded, about 228 words
    • Site details revised at 3 of 15 sites
  2. Re-verified, no change to tracked fieldsv13
  3. Study sites: 18 to 15v12
  4. Trial status: Recruiting to Completed Primary and study completion dates changed from estimate of Jun 30, 2025 to Aug 4, 2025 · Site details revised at 18 of 18 sitesv11 Show 2 more changesShow less
    • Primary and study completion dates changed from estimate of Jun 30, 2025 to Aug 4, 2025
    • Site details revised at 18 of 18 sites
  5. Re-verified, no change to tracked fieldsv10
Show 8 earlier versionsHide 8 earlier versions
  1. Primary and study completion dates: Jul 1, 2024 to Jun 30, 2025v9
  2. Study sites: 12 to 18v8
  3. Re-verified, no change to tracked fieldsv7
  4. Study sites: 8 to 12v6
  5. Study sites: 1 to 8v5
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Aug 15, 2022 to Sep 3, 2022v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 15, 2022 to Sep 3, 2022
  7. Start date: May 30, 2022 to Aug 15, 2022v3
  8. Start date: Dec 1, 2021 to May 30, 2022 Study title shortened, about 2 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The Drugs Controller General of India (DCGI) granted approval for Rahika® (capmatinib) film-coated tablets (150 mg and 200 mg) for the treatment of adult patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbored a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping. As a condition of approval, the DCGI required the conduct of a Phase IV clinical trial in Indian patients. As recommended by the DCGI, this Phase IV study was planned to evaluate the safety and efficacy of capmatinib in adult Indian patients with advanced or metastatic NSCLC with MET exon 14 skipping mutation-positive disease, in any line of therapy.
Trial Details
NCT Number NCT05110196
Lead Sponsor Novartis Pharmaceuticals
Conditions Non-Small Cell Lung Carcinoma
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov