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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

RecruitingPhase 2Ages 18 Years - 75 YearsAllRemeGen Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Voluntarily participate in the study and signed the ICF; 2. Male or female, aged 18-75 years; 3. 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; 4. For previously locally advanced or recurrent metastatic disease not treated with systemic antitumor therapy; 5. Carring 1 of 2 common EGFR mutations clearly associated with EGFR-TKI sensitivity (i.e., exon 19 deletion or L858R) and MET positivity; 6. Ability to provide at least 6 sections of tumor tissue specimens for staining and testing; 7. ECOG PS score 0 or 1; 8. At least one measurable lesion according to RECIST v1.1 criteria; 9. Expected survival ≥ 12 weeks; 10. Adequate bone marrow and organ function; 11. 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. Exclusion Criteria: 1. Subjects with the presence of meningeal metastases, spinal cord compression, or active brain metastases; 2. Received ADC or MET inhibitors; 3. 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; 4. Subjects with uncontrolled tumor-related pain; 5. Use of an investigational drug or major surgery within 4 weeks before the first dose; 6. Received any live vaccine within 28 days prior to the first dose or plan to be vaccinated during the study; 7. Subjects with uncontrolled or severe cardiovascular disease; 8. Presence of clinically uncontrollable third interstitial effusion; 9. Presence of severe lung disease, including but not limited to active tuberculosis, interstitial lung disease requiring treatment, radiation pneumonitis, etc. 10. 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; 11. Persistent grade ≥2 sensory or motor neuropathy; 12. Active infections requiring systemic IV antibiotic therapy within 7 days before the first dose, allowing routine antimicrobial prophylaxis; 13. Positive test result for Human Immunodeficiency Virus (HIV) or history of Acquired Immune Deficiency Syndrome (AIDS); 14. Active hepatitis B or HCV-positive subjects; 15. Received systemic corticosteroid therapy with \>10 mg/day prednisone or other immunosuppressive medications within 2 weeks before randomization; 16. Other malignant tumor within 5 years before signed the informed consent form; 17. Known hypersensitivity or delayed hypersensitivity to RC108, certain components of Furmonertinib or similar drugs or any contraindication to the drug; 18. Poor compliance and unable to complete the study procedures as assessed by investigator;
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What it tests

  • RC108
  • Furmonertinib Mesilate Tablets Monotherapy
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Where

34 sites
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

…and 26 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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