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

Status: Recruiting
Location: See all (34) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Beijing Chest Hospital,Capital Medical Unniversity
RECRUITING
Beijing
The Fifth Medical Center of Chinese People's Liberation Army General Hospital
RECRUITING
Beijing
Binzhou Medical University Hospital
RECRUITING
Binzhou
Jilin Cancer Hospital
RECRUITING
Changchun
The Second Xiangya Hospital Of Central South University
RECRUITING
Changsha
Changzhou Cancer Hospital
RECRUITING
Changzhou
Sichuan Cancer Hospital
RECRUITING
Chengdu
West China hospitial of SiChuan University
RECRUITING
Chengdu
Chongqing University Cancer Hospitai
RECRUITING
Chongqing
Fujian Cancer Hospital
RECRUITING
Fuzhou
Ganzhou cancer Hospitial
RECRUITING
Ganzhou
Affiliated Cancer Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Guilin
The Second Affiliated Hospital of Guilin Medical University
RECRUITING
Guilin
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Anhui Provincial cancer hospital
RECRUITING
Hefei
The First hospitial of Anhui Medicine University
RECRUITING
Hefei
Jinan Central Hospital
RECRUITING
Jinan
Shandong Cancer Hospital
RECRUITING
Jinan
The First hospitial of Lanzhou University
RECRUITING
Lanzhou
Linyi People's Hospital
RECRUITING
Linyi
THE FIRST HOSPITAI OF CHINA MEDICAL UNIVERSITY,No. 155, Nanjing North Street, Heping District, Shenyang City, Liaoning Province
RECRUITING
Shenyang
The Fourth Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Shanxi Cancer Hospital
RECRUITING
Taiyuan
Taizhou hospitial of Zhejiang province
RECRUITING
Taizhou
Tianjin Chest Hospital
RECRUITING
Tianjin
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Xiangyang Central Hospital
RECRUITING
Xiangyang
The Second People's Hospital of Yibin City
RECRUITING
Yibin
Yiyang Central Hospital
RECRUITING
Yiyang
Yueyang Central Hospital
RECRUITING
Yueyang
Yunnan Cancer Hospital
RECRUITING
Yunnan
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Heping Liu
heping.liu@remegen.com
+86-010-65384976
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 80
Treatments
Experimental: Arm 1
1L, EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC
Active_comparator: Arm 2
1L, EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC
Sponsors
Leads: RemeGen Co., Ltd.

This content was sourced from clinicaltrials.gov