Actively Recruiting
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
Led by Abbisko Therapeutics Co, Ltd · Updated on 2024-12-12
54
Participants Needed
5
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and early anti-tumor activity of a combination of two drugs, ABSK043 and Firmonertinib, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has a specific mutation in the EGFR gene. This Phase 2, open-label study focuses on patients with EGFR-mutated NSCLC and aims to find the best dose and schedule while closely monitoring patient safety. The study has two parts: Part A is a dose escalation phase that includes patients who have previously received treatment and experienced disease progression; Part B is a dose expansion phase involving patients who have not yet received systemic therapy for advanced disease. ABSK043 is given orally at either 400 mg or 800 mg twice daily, while Firmonertinib is given orally at a fixed dose of 80 mg once daily. Treatment cycles last 21 days, and patients continue therapy until disease progression, unacceptable side effects, withdrawal, or study end. Participants will undergo regular safety monitoring including assessments for dose-limiting toxicities, adverse events, serious adverse events, and specific side effects from the time they consent until up to 30 months after their last dose. Researchers will also measure progression-free survival at 12 months. Pharmacokinetic tests and tumor response evaluations are conducted during treatment. The total study duration per participant varies based on treatment response and safety outcomes.
CONDITIONS
Brief Title
A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with locally advanced or metastatic non-small cell lung cancer confirmed by tissue or cytology
- At least one measurable tumor lesion according to RECIST v1.1
- For dose escalation and confirmation: disease progression after treatment with EGFR-TKI for advanced disease and positive PDL1 expression (TPS/TC ≥1%) from tumor tissue
- For dose expansion: no prior systemic cancer therapy for advanced disease and positive PDL1 expression (TPS/TC ≥1%) by central lab
- Adequate bone marrow and organ function based on lab tests
- Genetic test confirming EGFR L858R or exon 19 deletion mutation in tumor or plasma ctDNA
You will not qualify if you...
- Predominant squamous cell histology or presence of small cell lung cancer or neuroendocrine carcinoma
- History of interstitial lung disease or active ILD
- Symptomatic spinal cord compression or active central nervous system metastases requiring corticosteroids or anticonvulsants; inactive brain metastases allowed
- Unresolved toxicities from prior cancer treatments above Grade 1 except hair loss
- Chronic systemic corticosteroid use above 10 mg prednisone or equivalent or any immunosuppressive therapy
- Uncontrolled or significant cardiovascular disease
- Known uncontrolled HIV infection
- Any severe or uncontrolled disease or condition making participation undesirable in the investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive oral combination therapy with ABSK043 and Firmonertinib every 21 days. They continue treatment until disease progression, intolerable toxicity, withdrawal, or end of the study.
Visits every 21 days corresponding with treatment cycles
Duration - Up to 30 months after treatment ends
Participants are monitored for safety and disease progression for up to 30 months after treatment ends.
Periodic visits for safety and efficacy assessments during follow-up
Trial Site Locations
Total: 5 locations
1
Hanhui Cancer Hospital
Hefei, Anhui, China
Not Yet Recruiting
2
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Not Yet Recruiting
3
Union Hospital Tongji Medical College Huzhong University of Science and Techology
Wuhan, Hubei, China
Not Yet Recruiting
4
Jilin Cancer Hospital
Changchun, Jilin, China
Not Yet Recruiting
5
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Y
Yuan Lu
Y
Yinan Lin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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