Non-Small Cell Lung CancerPhase 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 Phase 2 study testing RC108 and Furmonertinib Mesilate Tablets Monotherapy in people with Non-Small Cell Lung Cancer, run by RemeGen Co., Ltd. at 34 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- RC108 and Furmonertinib Mesilate Tablets Monotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 34 sitesChina
- Study dates
- 30 Jun 2025to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
Show all 11Show fewer
- 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.
Who cannot join
- 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;
Show all 18Show fewer
- 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;
- Other malignant tumor within 5 years before signed the informed consent form;
- Known hypersensitivity or delayed hypersensitivity to RC108, certain components of Furmonertinib or similar drugs or any contraindication to the drug;
- Poor compliance and unable to complete the study procedures as assessed by investigator;
Trial locations and contacts
34 sites in 1 country. Contact the study team or a site near you to ask about taking part.
34 sites in 1 country
China34 sites, 34 recruiting
- Recruiting
Beijing Chest Hospital,Capital Medical Unniversity
Beijing
- Recruiting
The Fifth Medical Center of Chinese People's Liberation Army General Hospital
Beijing
- Recruiting
Binzhou Medical University Hospital
Binzhou
Fangling Ning
- Recruiting
Jilin Cancer Hospital
Changchun
- Recruiting
The Second Xiangya Hospital Of Central South University
Changsha
fang Ma
- Recruiting
Changzhou Cancer Hospital
Changzhou
Tong Zhou
- Recruiting
Sichuan Cancer Hospital
Chengdu
yang Wei
- Recruiting
West China hospitial of SiChuan University
Chengdu
Panwen Tian
- Recruiting
Chongqing University Cancer Hospitai
Chongqing
- Recruiting
Fujian Cancer Hospital
Fuzhou
jing Zhang
- Recruiting
Ganzhou cancer Hospitial
Ganzhou
Shoujun Guo
- Recruiting
Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Guilin
Bihui Li
- Recruiting
The Second Affiliated Hospital of Guilin Medical University
Guilin
- Recruiting
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou
- Recruiting
Harbin Medical University Cancer Hospital
Harbin
yan Yu
- Recruiting
Anhui Provincial cancer hospital
Hefei
Changlu Hu
- Recruiting
The First hospitial of Anhui Medicine University
Hefei
Yiruo Zhang
- Recruiting
Jinan Central Hospital
Jinan
Meili sun
- Recruiting
Shandong Cancer Hospital
Jinan
Xiangjiao Meng
- Recruiting
The First hospitial of Lanzhou University
Lanzhou
Xiaoming Hou
- Recruiting
Linyi People's Hospital
Linyi
Guixiang Weng
- Recruiting
THE FIRST HOSPITAI OF CHINA MEDICAL UNIVERSITY,No. 155, Nanjing North Street, Heping District, Shenyang City, Liaoning Province
Shenyang
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang
- Recruiting
Shanxi Cancer Hospital
Taiyuan
- Recruiting
Taizhou hospitial of Zhejiang province
Taizhou
Dongqing Lv
- Recruiting
Tianjin Chest Hospital
Tianjin
- Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Ruiguang Zhang
- Recruiting
Xiangyang Central Hospital
Xiangyang
Tienan Yi
- Recruiting
The Second People's Hospital of Yibin City
Yibin
Jie Chen
- Recruiting
Yiyang Central Hospital
Yiyang
Bing Zhang
- Recruiting
Yueyang Central Hospital
Yueyang
Jie Weng
- Recruiting
Yunnan Cancer Hospital
Yunnan
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
About this study
Official title: 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
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
Read the detailed description
Primary objective: 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 Secondary objective: Evaluate the pharmacokinetic and immunogenicity characteristics of RC108 in combination with Furmonertinib
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- RC108, Furmonertinib Mesilate Tablets Monotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC108Drug
Also called RC108 For Injection；
RC108 in Combination With Furmonertinib
Furmonertinib Mesilate Tablets MonotherapyDrug
Also called Furmonertinib
Furmonertinib
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 1L, EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC Receives: Drug: RC108; Drug: Furmonertinib Mesilate Tablets Monotherapy |
| Arm 2 | Active comparator | 1L, EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC Receives: Drug: Furmonertinib Mesilate Tablets Monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Investigator-assessed ORR
Measured: 24 months
Secondary outcomes (7)
Progression-free survival (PFS)
Investigator-assessed PFS
Measured: 24 months
Disease Control Rate (DCR)
Investigator-assessed DCR
Measured: 24 months
Duration of Response (DoR)
Investigator-assessed DoR
Measured: 24 months
Overall survival (OS)
Investigator-assessed OS
Measured: 45 months
Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Measured: 24 months
Incidence of RC108 anti-drug antibody (ADA)
Incidence, occurrence time and ADA titer of positive RC108 ADA and neutralizing antibodies
Measured: 24 months
Pharmacokinetic profile of RC108
Peak and trough concentrations of RC108 total antibody (TAb), conjugated antibody (ADC), free MMAE
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start30 Jun 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by RemeGen Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yongchang Zhang, Study director, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962865
- Sponsor's protocol ID
- RC108-C006
- Status last verified
- Apr 2025
- First submitted
- 30 Apr 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06962865
- Acronym / sponsor ID
- RC108-C006
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Primary objective: 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 Secondary objective: Evaluate the pharmacokinetic and immunogenicity characteristics of RC108 in combination with Furmonertinib
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: RC108, Drug: Furmonertinib Mesilate Tablets Monotherapy1L, EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC |
| Arm 2 | Active comparator | Drug: Furmonertinib Mesilate Tablets Monotherapy1L, EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RC108Also: RC108 For Injection；RC108 in Combination With Furmonertinib | Drug | Arm 1 |
| Furmonertinib Mesilate Tablets MonotherapyAlso: FurmonertinibFurmonertinib | Drug | Arm 1, Arm 2 |
Primary outcome
Objective Response Rate (ORR)
Time frame: 24 months
Investigator-assessed ORR
7 secondary outcomes
Progression-free survival (PFS)
Time frame: 24 months
Disease Control Rate (DCR)
Time frame: 24 months
Duration of Response (DoR)
Time frame: 24 months
Overall survival (OS)
Time frame: 45 months
Number of participants with adverse events (AEs)
Time frame: 24 months
Incidence of RC108 anti-drug antibody (ADA)
Time frame: 24 months
Pharmacokinetic profile of RC108
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yongchang Zhang study director
Hunan Cancer Hospital
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RC108 and Furmonertinib Mesilate Tablets Monotherapy in people with Non-Small Cell Lung Cancer, run by RemeGen Co., Ltd. at 34 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heping Liu (+86-010-65384976, heping.liu@remegen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.