Clinical trial · Interventional
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)
NCT06668103CI-TRIAL-00083648recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer With EGFR Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABSK043 in combination with Firmonertinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ABSK043 in combination with Firmonertinib
- description
- This is an open-label phase 2 study with an escalation part and an expansion part. * Escalation part: Previously treated patients with EGFR Mutated NSCLC will be enrolled. * Dose escalation cohort: up to 12 patients; * Dose confirmation cohort: at least 3 patients, and up to 12 patients. * Expansion part: * Dose expansion cohort: up to 30 treatment-naïve patients with EGFR Mutated NSCLC are expected to be enrolled.
- interventionNames
- Drug: ABSK043 in combination with Firmonertinib
Primary outcomes (5)
- measure
- Incidence of DLT
- timeFrame
- At the end of Cycle 1 (each cycle is 21 days)
- description
- Dose-limiting toxicities
- measure
- AEs
- timeFrame
- From the time the patient signs the informed consent form throughout the study and up to 90 days after the last dose of ABSK043 or 30 days after the last dose of furmonertinib mesylate, whichever occurs first, up to 30 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.