Actively Recruiting
Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT05821933
RC108 Combine With Furmonertinib With/Without Toripalimab in Patients With EGFR-mutated NSCLC
Led by RemeGen Co., Ltd. · Updated on 2024-04-10
106
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
an open, single-arm, multicenter phase Ib/II study
CONDITIONS
Official Title
RC108 Combine With Furmonertinib With/Without Toripalimab in Patients With EGFR-mutated NSCLC
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age between 18 and 75 years old
- Expected survival of at least 12 weeks
- ECOG performance status of 0 or 1
- Female subjects must be surgically sterile, postmenopausal, or use contraception during and 6 months after treatment; negative pregnancy test required; not breastfeeding
- Male subjects must be surgically sterile or use contraception during and 6 months after treatment
- Able to understand and comply with trial and follow-up procedures
- Adequate bone marrow function: hemoglobin 9 g/dL, ANC 1.5 �d7 10^9/L, platelet count 100 �d7 10^9/L
- Adequate liver function according to clinical trial center standards
- Adequate kidney function: serum creatinine 1.5 �d7 ULN or creatinine clearance 60 mL/min
- Heart function: NYHA class less than 3, LVEF 50%, QTc interval 450 ms
- Locally advanced or metastatic NSCLC confirmed by histology or cytology
- At least one EGFR-sensitive mutation including exon 19 deletion, L858R, T790M, G719X, S768I, or L871Q (including exon 20 insertion mutation)
- Previous approved first/second/third-generation EGFR-TKI treatment with radiological progression
- Allowed prior systemic treatments such as chemotherapy and anti-angiogenic agents
- Provide tumor tissue sample with MET expression of 1+, 2+, or 3+
- Agree to provide tumor or blood samples for EGFR T790M detection
- Provide recent tumor tissue sample for PD-L1 expression testing
- At least one measurable lesion by RECIST 1.1 criteria
You will not qualify if you...
- Use of investigational drugs within 4 weeks before study dosing
- Major surgery within 4 weeks before study dosing without full recovery
- Live vaccine within 4 weeks before dosing or planned vaccination during study (except novel inactivated coronavirus vaccine)
- Arterial or venous thrombotic event within 6 months before dosing
- Clinically significant QT prolongation or arrhythmias increasing QT risk
- Preexisting or ongoing interstitial lung disease or drug-induced lung disease requiring steroids
- Uncontrollable symptomatic third interstitial fluid such as pleural, peritoneal, or pericardial effusion
- Systemic diseases not stably controlled including diabetes, hypertension, pulmonary fibrosis, liver cirrhosis
- Psychiatric or substance abuse disorders affecting compliance
- Active infections needing systemic treatment
- Active tuberculosis suspicion or presence
- Positive HIV, active hepatitis B or C infection
- Use of strong CYP3A4 inhibitors within 7 days or inducers within 21 days before first dose
- Other diseases or abnormalities making study participation inappropriate or high risk
- Pregnant or breastfeeding women or those planning to have children
- Poor compliance or other factors making participation unsuitable
- Known small cell lung cancer transformation or small cell component
- Brain metastases or cancerous meningitis, unless stable brain metastases meeting criteria
- Other malignancies within 5 years except certain effectively treated tumors
- Known hypersensitivity to study drugs or similar compounds
- Prior drugs targeting HGF and/or MET pathways
- Prior PD-1/L1 inhibitor use for certain study cohorts
- Recent chemotherapy, radiotherapy, immunotherapy, targeted therapy within 4 weeks or 5 half-lives
- Hormonal therapy within 2 weeks before dosing
- Palliative radiotherapy for bone metastases within 2 weeks before dosing
- Antitumor herbal therapy within 2 weeks before dosing
- Unrecovered toxicity from prior antitumor therapy except alopecia, hyperpigmentation, or long-term radiotherapy toxicity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
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Research Team
J
Jianmin Fang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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