IN10018 Combination Therapy in Advanced EGFR Mutation-positive NSCLC
- Registration Number
- NCT05994131
- Lead Sponsor
- InxMed (Shanghai) Co., Ltd.
- Brief Summary
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.
- Detailed Description
This study includes 2 parts: Phase Ib-Dose Confirmation and Phase II-Dose Expansion. And 3 cohorts are set up in this study as cohort 1 to enroll subjects currently accepting third-generation EGFR-TKI (Furmonertinib is proposed) as first-line treatment, cohort 2 to enroll subjects who previously accepted third-generation EGFR-TKI treatment and 1-2 lines chemotherapy, and cohort 3 to enroll treatment-naive advanced EGFR mutation-positive NSCLC subjects.
The phase Ib-dose confirmation part will be conducted in cohort 2 and aim to determine the recommended phase II dose (RP2D) of IN10018 in combination with Furmonertinib. Phase II-Dose Expansion part will be conducted in cohort 1-3 and further explore the antitumor efficacy, safety and PK of IN10018 in combination with Furmonertinib in subjects with previously-treated or naïve advanced EGFR mutation-positive NSCLC.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group in cohort 1, cohort 2, and cohort 3 IN10018 IN10018+Furmonertinib Experimental Group in cohort 1, cohort 2, and cohort 3 Furmonertinib IN10018+Furmonertinib Control Group in cohort 3 Furmonertinib Furmonertinib
- Primary Outcome Measures
Name Time Method Recommended phase II dose (RP2D) of IN10018 in combination with third-generation EGFR-TKI in subjects with advanced EGFR mutation-positive NSCLC. 3 years Evaluate the number of patients with dose-limited toxicities (DLTs); Determine the RP2D of IN10018 in combination with third-generation EGFR-TKI in subjects with advanced NSCLC.
ORR of IN10018 in combination with third-generation EGFR-TKI in subjects with advanced EGFR mutation-positive NSCLC. 3 years Defined as the proportion of subjects with complete response (CR) or partial response (PR)
Tumor Shrinkage Rate (TSR) of IN10018 in combination with third-generation EGFR-TKI in cohort 3 of advanced treatment-naive EGFR mutation-positive NSCLC. 3 years Defined as the percentage of subjects with the best shrinkage rate of target lesions ≥ 70% and simultaneously with a best response of partial response (PR) or complete response (CR).
- Secondary Outcome Measures
Name Time Method DCR of IN10018 in combination with third-generation EGFR-TKI in advanced EGFR mutation-positive NSCLC. 3 years Defined as the proportion of patients with CR, PR, or stable disease (SD).
PFS of IN10018 in combination with third-generation EGFR-TKI in advanced EGFR mutation-positive NSCLC. 3 years Defined as the time from the first dose of study treatment/randomization to first documentation of disease progression or to death due to any cause, whichever comes first.
Number of patients with adverse event 3 years The number of participants who experienced AEs is presented.
PK: AUC of IN10018 following single dose administration and at steady state 3 years Area under the concentration-time curve (AUC)
PK:Ctrough of IN10018 following single dose administration and at steady state 3 years Trough concentration (Ctrough)
PK:t1/2 of IN10018 following single dose administration and at steady state 3 years Elimination half-life (t1/2).
DOR of IN10018 in combination with third-generation EGFR-TKI in advanced EGFR mutation-positive NSCLC. 3 years Defined as the time from start of the first documentation of CR or PR to the first documentation of disease progression or to death due to any cause, whichever comes first.
OS of IN10018 in combination with third-generation EGFR-TKI in advanced EGFR mutation-positive NSCLC. 3 years Defined as the time from the first dose of study treatment/randomization to the date of death due to any cause.
PK: Cmax of IN10018 following single dose administration and at steady state 3 years Maximum concentration (Cmax)
PK:Tmax of IN10018 following single dose administration and at steady state 3 years Time to Cmax (Tmax)
PK:CL/F of IN10018 following single dose administration and at steady state 3 years apparent clearance (CL/F)
PK:Vd/F of IN10018 following single dose administration and at steady state 3 years Apparent volume of distribution (Vd/F)
Trial Locations
- Locations (1)
Shanghai Pulmonary Hospital
🇨🇳Shanghai, China