Combination therapy for advanced lung cancer with specific mutations
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)
This study is testing a new combination of two drugs to see if they can help people with advanced lung cancer that has certain mutations feel better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbisko Therapeutics Co, Ltd Industry-sponsored |
| Drugs / interventions | prednisone, Firmonertinib |
| Locations | 5 sites (Hefei, Anhui and 4 other locations) |
| Trial ID | NCT06668103 on ClinicalTrials.gov |
What this trial studies
This Phase 2 clinical study evaluates the safety and effectiveness of ABSK043 combined with Firmonertinib in patients with advanced non-small cell lung cancer (NSCLC) that has specific mutations in the epidermal growth factor receptor (EGFR). The study is divided into two parts: a dose escalation phase to determine the optimal dosage and a dose expansion phase to assess the treatment's efficacy as a first-line therapy. Participants will be closely monitored for safety throughout the trial.
Who should consider this trial
Good fit: Ideal candidates are patients with locally advanced or metastatic NSCLC who have specific EGFR mutations and meet the study's inclusion criteria.
Not a fit: Patients who have not been diagnosed with EGFR mutations or those who have received prior systemic therapies for advanced disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced lung cancer harboring EGFR mutations.
How similar studies have performed: Other studies have shown promise with similar combination therapies targeting EGFR mutations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically or cytologically documented locally advanced or metastatic NSCLC 2. At least 1 measurable lesion as assessed by Investigator as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) 3. Inclusion Criteria Specific to Dose Escalation cohort and Dose Confirmation Cohort：Must has disease progression following treatment with EGFR-TKI in the locally advanced or metastatic setting for locally advanced or metastatic disease Documentation of PDL1 expression positive (TPS/TC≥1%)detected from tumor tissue Inclusion Criteria Specific to Dose expansion Cohort： Must not have received any other prior systemic cancer therapies in the locally advanced/metastatic setting PDL1 expression positive (TPS/TC≥1%) as assessed by central laboratory from tumor tissue 4. Adequate bone marrow reserve and organ function based on local laboratory data . 5. Documented genetic testing reports confirmed the presence of EGFR L858R or EGFR exon 19 del mutations in tumor or plasma ctDNA. Exclusion Criteria: 1. 1\. Histological or cytological examinations suggest that NSCLC squamous cells is the predominant histology, or contains small cell lung cancer, neuroendocrine carcinoma, etc. 2. Has a history of interstitial lung disease (ILD)/pneumonitis or active ILD 3. Has spinal cord compression or clinically active central nervous system metastases, defined as symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study 4. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, Grade ≤1 or baseline. 5. Is receiving chronic systemic corticosteroids dosed at \>10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy. 6. Uncontrolled or significant cardiovascular disease 7. Has a known human immunodeficiency virus (HIV) infection that is not well controlled. 8. Any evidence of severe or uncontrolled diseases or other factors which in the Investigator's opinion makes it undesirable for the patients to participate in the study.
Where this trial is running
Hefei, Anhui and 4 other locations
- Hanhui Cancer Hospital — Hefei, Anhui, China (Not_yet_recruiting)
- Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Not_yet_recruiting)
- Union Hospital Tongji Medical College Huzhong University of Science and Techology — Wuhan, Hubei, China (Not_yet_recruiting)
- Jilin Cancer Hospital — Changchun, Jilin, China (Not_yet_recruiting)
- Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yuan Lu
- Email: clinical@abbisko.cn
- Phone: +86-21-68910052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.