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
NCT ID: NCT06962865
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-06-30
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
1L, EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC
RC108
RC108 in Combination With Furmonertinib
Furmonertinib Mesilate Tablets Monotherapy
Furmonertinib
Arm 2
1L, EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC
Furmonertinib Mesilate Tablets Monotherapy
Furmonertinib
Interventions
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RC108
RC108 in Combination With Furmonertinib
Furmonertinib Mesilate Tablets Monotherapy
Furmonertinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
75 Years
ALL
No
Sponsors
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RemeGen Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yongchang Zhang
Role: STUDY_DIRECTOR
Hunan Cancer Hospital
Locations
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Beijing Chest Hospital,Capital Medical Unniversity
Beijing, , China
The Fifth Medical Center of Chinese People's Liberation Army General Hospital
Beijing, , China
Binzhou Medical University Hospital
Binzhou, , China
Jilin Cancer Hospital
Changchun, , China
The Second Xiangya Hospital Of Central South University
Changsha, , China
Changzhou Cancer Hospital
Changzhou, , China
Sichuan Cancer Hospital
Chengdu, , China
West China hospitial of SiChuan University
Chengdu, , China
Chongqing University Cancer Hospitai
Chongqing, , China
Fujian Cancer Hospital
Fuzhou, , China
Ganzhou cancer Hospitial
Ganzhou, , China
Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, , China
The First Affiliated Hospital of Wenzhou Medical University
Guilin, , China
The Second Affiliated Hospital of Guilin Medical University
Guilin, , China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Anhui Provincial cancer hospital
Hefei, , China
The First hospitial of Anhui Medicine University
Hefei, , China
Jinan Central Hospital
Jinan, , China
Shandong Cancer Hospital
Jinan, , China
The First hospitial of Lanzhou University
Lanzhou, , China
Linyi People's Hospital
Linyi, , China
THE FIRST HOSPITAI OF CHINA MEDICAL UNIVERSITY,No. 155, Nanjing North Street, Heping District, Shenyang City, Liaoning Province
Shenyang, , China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, , China
Shanxi Cancer Hospital
Taiyuan, , China
Taizhou hospitial of Zhejiang province
Taizhou, , China
Tianjin Chest Hospital
Tianjin, , China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Xiangyang Central Hospital
Xiangyang, , China
The Second People's Hospital of Yibin City
Yibin, , China
Yiyang Central Hospital
Yiyang, , China
Yueyang Central Hospital
Yueyang, , China
Yunnan Cancer Hospital
Yunnan, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Yiruo Zhang
Role: primary
Meili sun
Role: primary
Xiangjiao Meng
Role: primary
Xiaoming Hou
Role: primary
Guixiang Weng
Role: primary
Dongqing Lv
Role: primary
Ruiguang Zhang
Role: primary
Tienan Yi
Role: primary
Jie Chen
Role: primary
Bing Zhang
Role: primary
Jie Weng
Role: primary
Fangling Ning
Role: primary
fang Ma
Role: primary
Tong Zhou
Role: primary
yang Wei
Role: primary
Panwen Tian
Role: primary
jing Zhang
Role: primary
Shoujun Guo
Role: primary
Bihui Li
Role: primary
yan Yu
Role: primary
Changlu Hu
Role: primary
Other Identifiers
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RC108-C006
Identifier Type: -
Identifier Source: org_study_id
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