RecruitingPhase 2NCT06668103

A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib

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)


Sponsor

Abbisko Therapeutics Co, Ltd

Enrollment

54 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 2 study tests a combination of two targeted cancer drugs — ABSK043 and firmonertinib — for people with advanced non-small cell lung cancer that has a specific EGFR gene mutation and expresses a protein called PD-L1. The study includes both patients who have already tried EGFR-targeted therapy and those who haven't. **You may be eligible if...** - You have advanced or metastatic non-small cell lung cancer - Your tumor has an EGFR mutation (exon 19 deletion or L858R) - Your tumor tests positive for PD-L1 (≥1%) - You have measurable tumors on scans - Your blood and organ function are within acceptable limits **You may NOT be eligible if...** - Your lung cancer is predominantly squamous cell type, or contains small cell or neuroendocrine components - You have had or currently have interstitial lung disease or serious lung inflammation - You have active or symptomatic brain metastases - You have unresolved significant side effects from prior treatment - You are on high-dose steroids or immunosuppressants Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGABSK043 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

View Full Details on ClinicalTrials.gov

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NCT06668103


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