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New treatment option for Non-Small Cell Lung Cancer
Official title 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
ClinicalTrials.gov ID: NCT06962865
What this study is testing
What is RC108?
RC108 is an investigational medicine, being studied as a potential treatment for non-small cell lung cancer.
Also referred to as RC108 For Injection；.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- 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;
You likely can't join if
- people 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...
- people 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;
See the full eligibility criteria
- 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...
- 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 people of childbearing potential or male people 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...
- people 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...
- people 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;
- people 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 people;
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Binzhou, China
- Changchun, China
- Changsha, China
- Changzhou, China
- Chengdu, China
- Chongqing, China
- Fuzhou, China
- Ganzhou, China
- Guangzhou, China
- Guilin, China
- Hangzhou, China
- Harbin, China
- Hefei, China
- Jinan, China
- Lanzhou, China
- Linyi, China
- Shenyang, China
- Shijiazhuang, China
- Taiyuan, China
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Binzhou, China; Changchun, China; Changsha, China; Changzhou, China; Chengdu, China and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.