Actively Recruiting
A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib
Led by Abbisko Therapeutics Co, Ltd · Updated on 2024-12-12
54
Participants Needed
5
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC
- At least one measurable tumor lesion per RECIST v1.1 criteria
- For dose escalation: disease progression after EGFR-TKI treatment with documented PD-L1 positive expression (TPS/TC ≥1%) from tumor tissue
- For dose expansion: no prior systemic therapy for advanced/metastatic disease and PD-L1 positive expression (TPS/TC ≥1%) confirmed centrally
- Adequate bone marrow and organ function based on local lab tests
- Confirmed presence of EGFR L858R or exon 19 deletion mutations in tumor or plasma ctDNA
You will not qualify if you...
- Predominant squamous cell NSCLC 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
- Unresolved toxicities from previous cancer treatments greater than Grade 1 (except alopecia)
- Current use of systemic corticosteroids above 10 mg prednisone equivalent or immunosuppressive therapy
- Uncontrolled or significant cardiovascular disease
- Known uncontrolled HIV infection
- Any severe or uncontrolled diseases or conditions that would make study participation undesirable as per investigator judgement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
Y
Yinan Lin
CONTACT
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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