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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

Phase 2
Not yet recruiting
Conditions
Non-Small Cell Lung Cancer
Interventions
Drug: Furmonertinib Mesilate Tablets Monotherapy
Registration Number
NCT06962865
Lead Sponsor
RemeGen Co., Ltd.
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

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
80
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;

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm 1RC1081L, EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC
Arm 1Furmonertinib Mesilate Tablets Monotherapy1L, EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC
Arm 2Furmonertinib Mesilate Tablets Monotherapy1L, EGFR-Mutated Combined MET-Positive Unresectable Locally Advanced or Recurrent Metastatic NSCLC
Primary Outcome Measures
NameTimeMethod
Objective Response Rate (ORR)24 months

Investigator-assessed ORR

Secondary Outcome Measures
NameTimeMethod
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 RC10824 months

Peak and trough concentrations of RC108 total antibody (TAb), conjugated antibody (ADC), free MMAE

Progression-free survival (PFS)24 months

Investigator-assessed PFS

Duration of Response (DoR)24 months

Investigator-assessed DoR

Overall survival (OS)45 months

Investigator-assessed OS

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.

Disease Control Rate (DCR)24 months

Investigator-assessed DCR

Trial Locations

Locations (34)

Beijing Chest Hospital,Capital Medical Unniversity

🇨🇳

Beijing, China

The Fifth Medical Center of Chinese People's Liberation Army General Hospital

🇨🇳

Beijing, China

Jilin Cancer Hospital

🇨🇳

Changchun, China

Chongqing University Cancer Hospitai

🇨🇳

Chongqing, China

Affiliated Cancer Hospital of Guangzhou Medical University

🇨🇳

Guangzhou, China

The Second Affiliated Hospital of Guilin Medical University

🇨🇳

Guilin, China

THE FIRST HOSPITAI OF CHINA MEDICAL UNIVERSITY,No. 155, Nanjing North Street, Heping District, Shenyang City, Liaoning Province

🇨🇳

Shenyang, China

The Fourth Hospital of Hebei Medical University

🇨🇳

Shijiazhuang, China

Tianjin Chest Hospital

🇨🇳

Tianjin, China

Yunnan Cancer Hospital

🇨🇳

Yunnan, China

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Beijing Chest Hospital,Capital Medical Unniversity
🇨🇳Beijing, China
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