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A Phase III Study of AL3818 (Anlotinib, Catequentinib) Hydrochloride Monotherapy in Subjects With Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma

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Trial Profile

A Phase III Study of AL3818 (Anlotinib, Catequentinib) Hydrochloride Monotherapy in Subjects With Metastatic or Advanced Alveolar Soft Part Sarcoma, Leiomyosarcoma and Synovial Sarcoma

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Feb 2026

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At a glance

  • Drugs Catequentinib (Primary) ; Dacarbazine; Digoxin; Midazolam; Rosuvastatin
  • Indications Alveolar soft part sarcoma; Leiomyosarcoma; Non-small cell lung cancer; Small cell lung cancer; Soft tissue sarcoma; Synovial sarcoma; Thyroid cancer
  • Focus Pharmacokinetics; Therapeutic Use
  • Acronyms APROMISS
  • Sponsors Advenchen Laboratories

Most Recent Events

  • 25 Feb 2026 Number of treatment arms are increased from 6 to 7 by the addition of "Active Comparator: Indication E (Any sarcomas or other solid tumors such as NSCLC, SCLC and Thyroid cancer etc.)" arm. Primary "pharmacokinetic" end-point is added.
  • 25 Feb 2026 Planned End Date changed from 1 Jun 2025 to 1 Dec 2028.
  • 25 Feb 2026 Planned primary completion date changed from 1 Dec 2024 to 1 Dec 2027.

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