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Recruiting Phase 2

A Phase Ⅱ Study of RC108 in Combination With Furmonertinib for the First-line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC

NCT06962865 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2025-06-30
Last updated
2025-07-16

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

RC108Furmonertinib Mesilate Tablets Monotherapy →

RC108: RC108 in Combination With Furmonertinib

Furmonertinib Mesilate Tablets Monotherapy: Furmonertinib

Study summary

Evaluate the efficacy and safety of RC108 in combination with Furmonertinib against Furmonertinib for treatment of EGFR mutation combined with MET-positive unresectable locally advanced or recurrent metastatic NSCLC

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Voluntarily participate in the study and signed the ICF; 2. Male or female, aged 18-75 years; 3. All participants to be enrolled must be diagnosed with histopathologically or cytologically confirmed, unresectable locally advanced (stage IIIB/IIIC )or recurrent metastatic NSCLC (stage IV ) and not amendable to curative surgery or radiation as assessed by investigator; 4. For previously locally advanced or recurrent metastatic disease not treated with systemic antitumor therapy; 5. Carring 1 of 2 common EGFR mutations clearly associated with EGFR-TKI sensitivity (i.e., exon 19 deletion or L858R) and MET positivity; 6. Ability to provide at least 6 sections of tumor tissue specimens for staining and testing; 7. ECOG PS score 0 or 1; 8. At least one measurable lesion according to RECIST v1.1 criteria; 9. Expected survival ≥ 12 weeks; 10. Adequate bone marrow and organ function; 11. Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose, during which time the female subject is not breastfeeding and the male subject avoids sperm donation. Exclusion Criteria: 1. Subjects with the presence of meningeal metastases, spinal cord compression, or active brain metastases; 2. Received ADC or MET inhibitors; 3. Suffering from refractory nausea and vomiting, chronic gastrointestinal disorders, inability to swallow pharmaceutical preparations, or previous major bowel resection that may prevent adequate absorption, distribution, metabolism, or excretion of oral medications; 4. Subjects with uncontrolled tumor-related pain; 5. Use of an investigational drug or major surgery within 4 weeks before the first dose; 6. Received any live vaccine within 28 days prior to the first dose or plan to be vaccinated during the study; 7. Subjects with uncontrolled or severe cardiovascular disease; 8. Presence of clinically uncontrollable third interstitial effusion; 9. Presence of severe lung disease, including but not limited to active tuberculosis, interstitial lung disease requiring treatment, radiation pneumonitis, etc. 10. Toxicity due to prior antineoplastic therapy has not recovered to National Cancer Institute Commonly Used Criteria Terminology for Generic Adverse Events, Version 5.0, Grade 0-1; 11. Persistent grade ≥2 sensory or motor neuropathy; 12. Active infections requiring systemic IV antibiotic therapy within 7 days before the first dose, allowing routine antimicrobial prophylaxis; 13. Positive test result for Human Immunodeficiency Virus (HIV) or history of Acquired Immune Deficiency Syndrome (AIDS); 14. Active hepatitis B or HCV-positive subjects; 15. Received systemic corticosteroid therapy with \>10 mg/day prednisone or other immunosuppressive medications within 2 weeks before randomization; 16. Other malignant tumor within 5 years before signed the informed consent form; 17. Known hypersensitivity or delayed hypersensitivity to RC108, certain components of Furmonertinib or similar drugs or any contraindication to the drug; 18. Poor compliance and unable to complete the study procedures as assessed by investigator;

Primary outcome measure(s)

  • Objective Response Rate (ORR) — 24 months
    Investigator-assessed ORR

Trial sites (34)

FacilityCityRegionStatus
Beijing Chest Hospital,Capital Medical Unniversity Beijing China Recruiting
The Fifth Medical Center of Chinese People's Liberation Army General Hospital Beijing China Recruiting
Binzhou Medical University Hospital Binzhou China Recruiting
Jilin Cancer Hospital Changchun China Recruiting
The Second Xiangya Hospital Of Central South University Changsha China Recruiting
Changzhou Cancer Hospital Changzhou China Recruiting
Sichuan Cancer Hospital Chengdu China Recruiting
West China hospitial of SiChuan University Chengdu China Recruiting
Chongqing University Cancer Hospitai Chongqing China Recruiting
Fujian Cancer Hospital Fuzhou China Recruiting
Ganzhou cancer Hospitial Ganzhou China Recruiting
Affiliated Cancer Hospital of Guangzhou Medical University Guangzhou China Recruiting
The First Affiliated Hospital of Wenzhou Medical University Guilin China Recruiting
The Second Affiliated Hospital of Guilin Medical University Guilin China Recruiting
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University Hangzhou China Recruiting
Harbin Medical University Cancer Hospital Harbin China Recruiting
Anhui Provincial cancer hospital Hefei China Recruiting
The First hospitial of Anhui Medicine University Hefei China Recruiting
Jinan Central Hospital Jinan China Recruiting
Shandong Cancer Hospital Jinan China Recruiting
The First hospitial of Lanzhou University Lanzhou China Recruiting
Linyi People's Hospital Linyi China Recruiting
THE FIRST HOSPITAI OF CHINA MEDICAL UNIVERSITY,No. 155, Nanjing North Street, Heping District, Shenyang City, Liaoning Province Shenyang China Recruiting
The Fourth Hospital of Hebei Medical University Shijiazhuang China Recruiting
Shanxi Cancer Hospital Taiyuan China Recruiting
Taizhou hospitial of Zhejiang province Taizhou China Recruiting
Tianjin Chest Hospital Tianjin China Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan China Recruiting
Xiangyang Central Hospital Xiangyang China Recruiting
The Second People's Hospital of Yibin City Yibin China Recruiting
Yiyang Central Hospital Yiyang China Recruiting
Yueyang Central Hospital Yueyang China Recruiting
Yunnan Cancer Hospital Yunnan China Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06962865 on ClinicalTrials.gov ↗ ← All trials in China