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A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib
Sponsor: Abbisko Therapeutics Co, Ltd
Summary
This is an open-label phase 2 study to evaluate the safety, tolerability and preliminary anti-tumour activity of ABSK043 in combination with Firmonertinib in patients with Epidermal Growth Factor Receptor-mutated (EGFRm+) locally advanced or metastatic NSCLC.
Official title: A Phase 2, Open-Label Study to Evaluate the Efficacy and Safety of ABSK043 Combined With Firmonertinib in Patients With EGFR Mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer(NSCLC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
54
Start Date
2024-11-25
Completion Date
2028-06-30
Last Updated
2024-12-12
Healthy Volunteers
No
Interventions
ABSK043 in combination with Firmonertinib
Two potential dose levels :400 mg twice daily (BID) and 800 mg BID) of ABSK043 are prespecified and firmonertinib will be administered orally at a fixed dose of 80 mg once daily (QD). Patients in dose escalation cohort will receive the ABSK043, 400 mg BID and firmonertinib 80 mg QD as the starting dose for the combination therapy. Patients in dose confirmation cohort and dose expansion cohort will receive the recommended dose in dose escalation cohort and be evaluated for safety and preliminary anti-tumor activity of the combination therapy. After Cycle 1, patients will continue to receive combination therapy every 21 days until disease progression, death, loss to follow-up, withdrawal of consent, intolerable toxicity, investigator decision to discontinue treatment, or end of the study.
Locations (5)
Hanhui Cancer Hospital
Hefei, Anhui, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Union Hospital Tongji Medical College Huzhong University of Science and Techology
Wuhan, Hubei, China
Jilin Cancer Hospital
Changchun, Jilin, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China