A Phase Ib/II Clinical Trial to Evaluate the Anti-tumor Efficacy, Safety, Tolerability, and Pharmacokinetics of IN10018 Combined With Anti-PD-1/L1 Antibody and Chemotherapy as First-line Treatment in Extensive-stage Small Cell Lung Cancer
Overview
- Phase
- Phase 1
- Intervention
- IN10018
- Conditions
- Small Cell Lung Cancer Extensive Stage
- Sponsor
- InxMed (Shanghai) Co., Ltd.
- Enrollment
- 120
- Locations
- 3
- Primary Endpoint
- To identify the Recommended phase II dose (RP2D) of IN10018 in combination with Tislelizumab, Carboplatin and Etoposide in first-line ES-SCLC.
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Experimental group
IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC.
Intervention: IN10018
Experimental group
IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC.
Intervention: Tislelizumab
Experimental group
IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC.
Intervention: Carboplatin
Experimental group
IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC.
Intervention: Etoposide
Control group
Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC
Intervention: Tislelizumab
Control group
Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC
Intervention: Carboplatin
Control group
Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC
Intervention: Etoposide
Outcomes
Primary Outcomes
To identify the Recommended phase II dose (RP2D) of IN10018 in combination with Tislelizumab, Carboplatin and Etoposide in first-line ES-SCLC.
Time Frame: 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
Time Frame: 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 Outcomes
- 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)
- PK: AUC of IN10018 following single dose administration and at steady state(Up to 3 years)
- 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)
- Number of patients with adverse event(Up to 3 years)
- PK: Cmax of IN10018 following single dose administration and at steady state(Up to 3 years)
- PK: Ctrough of IN10018 following single dose administration and at steady state(Up to 3 years)
- PK: Tmax of IN10018 following single dose administration and at steady state(Up to 3 years)
- PK: Vd/F of IN10018 following single dose administration and at steady state(Up to 3 years)
- 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)
- 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)
- PK: t1/2 of IN10018 following single dose administration and at steady state(Up to 3 years)
- PK: CL/F of IN10018 following single dose administration and at steady state(Up to 3 years)
- 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)