Actively Recruiting
IN10018 Combination Therapy in Advanced EGFR Mutation-positive NSCLC
Led by InxMed (Shanghai) Co., Ltd. · Updated on 2025-04-30
110
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label, phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and antitumor efficacy of IN10018 in combination with third-generation EGFR-TKI (Furmonertinib is the proposed) in previously-treated or naïve advanced EGFR-mutation positive NSCLC.
CONDITIONS
Official Title
IN10018 Combination Therapy in Advanced EGFR Mutation-positive NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- Male or female aged 18 years or older
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC not suitable for surgery or radiotherapy
- Documented EGFR mutations sensitive to EGFR-TKI including Ex19del or L858R; coexisting mutations like T790M allowed
- Prior treatment for cohorts: Cohort 1 on Furmonertinib as first-line; Cohort 2 failed third-generation EGFR-TKI and 1-2 lines chemotherapy; Cohort 3 treatment-naive except prior adjuvant/neoadjuvant chemotherapy finished >6 months before progression
- Measurable lesions per RECIST 1.1 at baseline
- ECOG performance status of 0 or 1
- Estimated life expectancy over 3 months
- Adequate bone marrow, liver, kidney, and coagulation function within 7 days before treatment start
You will not qualify if you...
- Major surgery or trauma within 28 days before treatment start
- Prior systemic antitumor therapy not allowed for each cohort as specified, including chemotherapy, targeted therapy, immunotherapy, biological therapy except Furmonertinib in Cohort 1
- Presence of other gene mutations like ALK, MET, HER2, RAS after progression on prior EGFR-TKI in Cohort 2
- Received EGFR-TKI treatment in Cohort 3
- Prior treatment with FAK inhibitors
- Use of potent CYP3A4 or P-gp inhibitors/inducers within 14 days before treatment or expected during study
- Radiotherapy covering more than 30% of bone marrow within 28 days before treatment
- Interstitial lung disease or active clinically significant ILD
- History of other cancers within 3 years
- Symptoms of spinal cord compression, active CNS metastases, or carcinomatous meningitis
- Severe cardiovascular or cerebrovascular disease within 6 months
- Uncontrolled pleural, pericardial effusion or ascites
- Significant hemoptysis within 1 month or expected continuous hemostasis
- Active infections poorly controlled by treatment
- Active tuberculosis
- Known allergy or intolerance to study drugs
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Pulmonary Hospital
Shanghai, China
Actively Recruiting
Research Team
B
Bohong Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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