NCT04354961

Almonertinib as First-line Treatment in Patients With EGFR+ Positive Pulmonary Adenosquamous Carcinoma or Combined Adenocarcinoma and Squamous Cell Carcinoma

Aumolertinib as First-line Treatment in EGFR-Mutant Pulmonary Adenosquamous Carcinoma: A Multicenter, Single-Arm, Prospective Study (ARISE)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, single-arm clinical trial.

Detailed description

This is a multicenter, single arm, phase II study assessing the efficacy and safety of Almonertinib as first-line treatment in patients with EGFR mutation positive locally advanced or metastatic Pulmonary Adenosquamous Carcinoma.

Conditions

• Pulmonary Adenosquamous Carcinoma

Interventions

Type	Name	Description
DRUG	Almonertinib	Almonertinib 110mg PO once daily. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.

Timeline

• Start date: 2021-05-07
• Primary completion: 2023-12-31
• Completion: 2025-06-30
• First posted: 2020-04-21
• Last updated: 2023-11-08

Locations

18 sites across 1 country: China