Combination therapy for advanced lung cancer with specific mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Chest Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• 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

Study contacts

• Study coordinator: Yuan Lu
• Email: clinical@abbisko.cn
• Phone: +86-21-68910052

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing firmonertinib to chemotherapy for advanced lung cancer with specific mutations

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.