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
A Randomized, Open, Controlled, Multicenter Phase II Clinical Study of RC108 in Combination With Furmonertinib Versus Furmonertinib for the First-Line Treatment of EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC
1 other identifier
interventional
80
1 country
34
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 nonsmall-cell-lung-cancer
Started Jun 2025
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2025
CompletedFirst Posted
Study publicly available on registry
May 8, 2025
CompletedStudy Start
First participant enrolled
June 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
July 16, 2025
April 1, 2025
11 months
April 30, 2025
July 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Objective Response Rate (ORR)
Investigator-assessed ORR
24 months
Secondary Outcomes (7)
Progression-free survival (PFS)
24 months
Disease Control Rate (DCR)
24 months
Duration of Response (DoR)
24 months
Overall survival (OS)
45 months
Number of participants with adverse events (AEs)
24 months
- +2 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTAL1L, EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC
Arm 2
ACTIVE COMPARATOR1L, EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC
Interventions
Eligibility Criteria
You may qualify if:
- Voluntarily participate in the study and signed the ICF;
- Male or female, aged 18-75 years;
- 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;
- For previously locally advanced or recurrent metastatic disease not treated with systemic antitumor therapy;
- Carring 1 of 2 common EGFR mutations clearly associated with EGFR-TKI sensitivity (i.e., exon 19 deletion or L858R) and MET positivity;
- Ability to provide at least 6 sections of tumor tissue specimens for staining and testing；
- ECOG PS score 0 or 1；
- At least one measurable lesion according to RECIST v1.1 criteria；
- Expected survival ≥ 12 weeks;
- Adequate bone marrow and organ function；
- 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.
You may not qualify if:
- Subjects with the presence of meningeal metastases, spinal cord compression, or active brain metastases；
- Received ADC or MET inhibitors；
- 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;
- Subjects with uncontrolled tumor-related pain；
- Use of an investigational drug or major surgery within 4 weeks before the first dose;
- Received any live vaccine within 28 days prior to the first dose or plan to be vaccinated during the study;
- Subjects with uncontrolled or severe cardiovascular disease;
- Presence of clinically uncontrollable third interstitial effusion;
- Presence of severe lung disease, including but not limited to active tuberculosis, interstitial lung disease requiring treatment, radiation pneumonitis, etc.
- 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;
- Persistent grade ≥2 sensory or motor neuropathy;
- Active infections requiring systemic IV antibiotic therapy within 7 days before the first dose, allowing routine antimicrobial prophylaxis;
- Positive test result for Human Immunodeficiency Virus (HIV) or history of Acquired Immune Deficiency Syndrome (AIDS);
- Active hepatitis B or HCV-positive subjects;
- Received systemic corticosteroid therapy with \>10 mg/day prednisone or other immunosuppressive medications within 2 weeks before randomization;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yongchang Zhang
Hunan Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2025
First Posted
May 8, 2025
Study Start
June 30, 2025
Primary Completion (Estimated)
May 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
July 16, 2025
Record last verified: 2025-04