Furmonertinib for advanced lung cancer patients with specific EGFR mutations

A Single Arm, Multicenter Study of First-line Furmonertinib Treatment in Patients With Advanced Epidermal Growth Factor Receptor Uncommon Mutation Positive Non-small Cell Lung Cancer

This study is testing a new drug called furmonertinib to see if it helps people with advanced lung cancer who have certain genetic mutations feel better as their first treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Chongqing University Cancer Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, Furmonertinib
• Locations: 3 sites (Chongqing, Chongqing and 2 other locations)
• Trial ID: NCT05548348 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of furmonertinib, a novel pan-EGFR tyrosine kinase inhibitor, in patients with advanced non-small cell lung cancer (NSCLC) who have specific EGFR mutations (G719X, S768I, L861Q). The study is a single-arm, multicenter trial that will recruit approximately 30 patients in China, administering furmonertinib at a daily dose of 160 mg. The aim is to determine whether this treatment can provide benefits as a first-line therapy for these patients, who have not received prior systemic anti-tumor therapy.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-70 with pathologically confirmed advanced NSCLC and specific EGFR mutations who have not undergone previous systemic therapy.

Not a fit: Patients with NSCLC that does not have the specified EGFR mutations or those who have received prior systemic anti-tumor therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective first-line option for patients with advanced NSCLC harboring uncommon EGFR mutations.

How similar studies have performed: While furmonertinib has shown promise in other EGFR mutation contexts, this specific application in uncommon mutations is novel and has not been previously reported.

Eligibility criteria

Inclusion Criteria:

* Provide informed consent prior to any study specific procedures;
* 18 -70 years of age;
* ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks, life expectancy ≥12 weeks;
* Pathologically confirmed Non-Small Cell Lung Cancer (NSCLC);
* Locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy (stage IIIB-IV, according to the 8th edition of the AJCC staging system);
* Patient with EGFR G719X or S768I or L861Q mutation diagnosed histologically or cytologically, the reports must be issued or recognized by Tier 3A hospitals. The mutations above may exist alone or together;
* No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC;
* According to RECIST 1.1, patients have at least one tumor lesion at baseline that meets the following requirements: accurately and repeatably measurable at baseline have no radiotherapy or biopsy;
* For premenopausal women with childbearing potential, a pregnancy test must be performed within 14 days before the first dose, and the pregnancy test (blood or urine test) must be negative; female subjects must not be lactating;
* Willing to use contraception (male patients); Voluntary and agree to follow the study treatment protocol as well as follow-up plan, and can accept the oral medicine treatment.

Exclusion Criteria:

* small cell lung carcinoma;
* History of hypersensitivity to active or inactive excipients of investigational product (IP) or drugs with a similar chemical structure or class to investigational product (IP);
* Confirmed EGFR Ex20ins or Ex19del or L858R or T790M mutant;
* Patient who receive prior treatment including: any Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI); the patients who have received intrapleural perfusion therapy can only be enrolled 28 days or more after the pleural effusion is stable; major surgery within 4 weeks of the first dose of investigational product (IP); radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of IP; CYP3A4 strong inhibitor or strong inducer is used within 7 days prior to the first dose, or need to receive these drugs during the study period; traditional Chinese medicine and traditional Chinese medicine preparations with anti-tumor as indications and with adjuvant treatment of tumor is used within 7 days prior to the first dose, or need to receive these drugs during the study period; patients who are receiving drugs known to prolong QTc interval or may cause torsade de pointe and need to continue to receive these drugs during the study period; the time from the treatment with any other investigational product or its analogue to the first dose does not exceed 5 half-lives of the drug or 14 days, whichever is longer.
* Prior treatment with any systemic anti-cancer therapy for advanced Non-Small Cell Lung Cancer (NSCLC) including chemotherapy, biologic therapy, target therapy, immunotherapy, or any investigational drug, except neoadjuvant or adjuvant therapy before 6 months prior to the first dose IP;
* At the beginning of study treatment, any unresolved toxic reaction to prior treatment is present, which exceeds Grade 1 in accordance with Common Terminology Criteria for Adverse Events (CTCAE) (except for alopecia), and exceeds Grade 2 for prior platinum treatment-related neuropathy;
* Spinal cord compression; symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, and have a stable neurological status for at least 2 weeks after completion of the definitive therapy and steroids.
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of IP;
* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, and active infection, which in the Investigator's opinion makes it undesirable for the patient to participate in the trial;
* Past medical history of Interstitial Lung Disease (ILD), drug-induced Interstitial Lung Disease, radiation pneumonitis that required steroid treatment, or any evidence of clinically active Interstitial Lung Disease;
* Any evidence of corneal injury;
* Inadequate bone marrow reserve or organ function;
* QT prolongation or any clinically important abnormalities in rhythm and heart function;
* Pregnancy or lactation;
* Patients who may have poor compliance with the research procedures and requirements, etc., as judged by investigators.

Where this trial is running

Chongqing, Chongqing and 2 other locations

• The Second Affilicated Hospital of Chongqing Medical University — Chongqing, Chongqing, China (Recruiting)
• Chongqing University Cancer Hospital — Chongqing, Chongqing, China (Recruiting)
• Army Specialty Medical Center — Chongqing, Chongqing, China (Recruiting)

Study contacts

• Principal investigator: Yongsheng Li, M.D. & Ph.D. — Chongqing University Cancer Hospital
• Study coordinator: Yongsheng Li, M.D. & Ph.D.

Conditions Non-small Cell Lung Cancer; EGFR G719X; EGFR L861Q; EGFR S768I