Non-Small Cell Lung Cancer
Conditions
Brief 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
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
Interventions
DRUGRC108
RC108 in Combination With Furmonertinib
DRUGFurmonertinib Mesilate Tablets Monotherapy
Furmonertinib
Sponsors
RemeGen Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 24 months | Investigator-assessed ORR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | 24 months | Investigator-assessed DCR |
| Duration of Response (DoR) | 24 months | Investigator-assessed DoR |
| Overall survival (OS) | 45 months | Investigator-assessed OS |
| Progression-free survival (PFS) | 24 months | Investigator-assessed PFS |
| Incidence of RC108 anti-drug antibody (ADA) | 24 months | Incidence, occurrence time and ADA titer of positive RC108 ADA and neutralizing antibodies |
| Pharmacokinetic profile of RC108 | 24 months | Peak and trough concentrations of RC108 total antibody (TAb), conjugated antibody (ADC), free MMAE |
| Number of participants with adverse events (AEs) | 24 months | 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. |
Countries
China
Contacts
Primary ContactHeping Liu
Outcome results
None listed