IN10018 Combination Therapy in Treatment-naïve ES-SCLC
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Interventions
- Registration Number
- NCT06030258
- Lead Sponsor
- InxMed (Shanghai) Co., Ltd.
- Brief Summary
This is a multicenter, open-label, Randomized, phase Ib/II clinical study to evaluate the anti-tumor efficacy, safety, tolerability, and PK of IN10018 in combination with anti-PD-1/L1 monoclonal antibody (Tislelizumab is proposed as the combination drug) and chemotherapy (platinum and etoposide) as the first-line treatment in Extensive-stage small cell lung cancer (ES-SCLC).
- Detailed Description
This study consists of 2 parts: 1) Phase Ib-Dose Confirmation part: To assess the PK parameters, safety and recommended phase II dose (RP2D) of IN10018 in combination with anti-PD-1/L1 monoclonal antibody (Tislelizumab is proposed as the combination drug), platinum (carboplatin is proposed as the combination drug) and etoposide as the first-line treatment in ES-SCLC. 2) Phase II-Dose Expansion part: To assess the antitumor efficacy, safety and tolerability in the experimental group of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to the control group of Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group IN10018 IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC. Control group Etoposide Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC Experimental group Tislelizumab IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC. Experimental group Etoposide IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC. Control group Carboplatin Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC Experimental group Carboplatin IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC. Control group Tislelizumab Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC
- Primary Outcome Measures
Name Time Method To identify the Recommended phase II dose (RP2D) of IN10018 in combination with Tislelizumab, Carboplatin and Etoposide in first-line ES-SCLC. Up to 3 years Evaluate proportion of patients suffered with AEs defined as dose-limited toxicities (DLTs) per protocol; and RP2D will be determined per the incidence of AEs defined as DLTs.
Progress free survival (PFS) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per BICR based on RECIST 1.1 Up to 3 years Defined as the time from randomization to first documentation of disease progression or to death due to any cause, whichever comes first.
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per BICR and investigator based on RECIST 1.1. Up to 3 years Defined as the proportion of subjects with complete response (CR) or partial response (PR).
PK: AUC of IN10018 following single dose administration and at steady state Up to 3 years Area under the concentration-time curve (AUC)
Duration of objective response (DOR) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per BICR and investigator based on RECIST 1.1. Up to 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.
Number of patients with adverse event Up to 3 years The number of participants who experienced AEs is presented.
PK: Cmax of IN10018 following single dose administration and at steady state Up to 3 years Maximum concentration (Cmax)
PK: Ctrough of IN10018 following single dose administration and at steady state Up to 3 years Trough concentration (Ctrough)
PK: Tmax of IN10018 following single dose administration and at steady state Up to 3 years Time to Cmax (Tmax)
PK: Vd/F of IN10018 following single dose administration and at steady state Up to 3 years Apparent volume of distribution (Vd/F)
PFS of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per investigator based on RECIST 1.1 Up to 3 years Defined as the time from randomization to first documentation of disease progression or to death due to any cause, whichever comes first.
Disease Control Rate (DCR) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC per BICR and investigator based on RECIST 1.1 Up to 3 years Defined as the proportion of patients with CR, PR, or stable disease (SD).
PK: t1/2 of IN10018 following single dose administration and at steady state Up to 3 years Elimination half-life (t1/2)
PK: CL/F of IN10018 following single dose administration and at steady state Up to 3 years apparent clearance (CL/F)
Overall survival (OS) of IN10018 in combination with Tislelizumab, carboplatin and etoposide as compared to Tislelizumab in combination with carboplatin and etoposide in first-line ES-SCLC. Up to 3 years Defined as the time from randomization to the date of death due to any cause.
Trial Locations
- Locations (3)
Shandong Province Cancer Hospital
🇨🇳Jinan, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, China