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NCT07710612
PHASE2

A Phase 2 Study of ABSK043 Combined With Osimertinib

Sponsor: Abbisko Therapeutics Co, Ltd

View on ClinicalTrials.gov

Summary

This is a phase 2, open-Label study to evaluate the efficacy and safety of ABSK043 Combined with Osimertinib in participants with EGFR-Mutated locally advanced or metastatic Non-Small Cell Lung Cancer

Official title: A Phase 2, Open-Label Study to Evaluate the Efficacy and Safety of ABSK043 Combined With Osimertinib in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2026-08-31

Completion Date

2030-12-31

Last Updated

2026-07-17

Healthy Volunteers

No

Interventions

DRUG

ABSK043 in combination with Osimertinib

Three potential dose levels of ABSK043 are prespecified, and Osimertinib will be administered orally at a fixed dose of 80 mg QD in escalation cohort. 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.

Locations (7)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China