RecruitingPhase 2NCT06962865

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

Sponsor

RemeGen Co., Ltd.

Enrollment

80 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug combination — RC108 plus furmonertinib — as a first treatment for people with advanced non-small cell lung cancer (NSCLC) that has two specific genetic features: an EGFR mutation (a change in a gene that drives cancer growth) and MET overexpression (a protein that can make the cancer harder to treat). RC108 is a new antibody-drug conjugate, and furmonertinib is a targeted pill. **You may be eligible if...** - You are between 18 and 75 years old - You have been confirmed by biopsy to have unresectable locally advanced or metastatic non-small cell lung cancer - Your cancer has a specific EGFR mutation (exon 19 deletion or L858R) AND MET positivity - You have not yet received systemic cancer treatment - You are in good general health (ECOG 0 or 1) with a life expectancy of at least 12 weeks **You may NOT be eligible if...** - Your cancer has spread to the brain and is actively causing symptoms - You have previously received ADC drugs or MET inhibitor treatments - You have serious gastrointestinal problems preventing medication absorption - You have active hepatitis B or C, HIV, or active tuberculosis - You have uncontrolled heart problems, severe lung disease, or active autoimmune disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRC108

RC108 in Combination With Furmonertinib

DRUGFurmonertinib Mesilate Tablets Monotherapy

Furmonertinib

Locations(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

View Full Details on ClinicalTrials.gov

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NCT06962865

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