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Experimental group for Small Cell Lung Cancer

Phase 1 & 2
Recruiting
Led By Jun Zhao
Research Sponsored by InxMed (Shanghai) Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

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).

Eligible Conditions
  • Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
To identify the Recommended phase II dose (RP2D) of IN10018 in combination with Tislelizumab, Carboplatin and Etoposide in first-line ES-SCLC.
Secondary study objectives
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
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.
Number of patients with adverse event
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental groupExperimental Treatment4 Interventions
IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC.
Group II: Control groupActive Control3 Interventions
Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2960
IN10018
2020
Completed Phase 1
~40
Tislelizumab
2018
Completed Phase 3
~4560
Carboplatin
2014
Completed Phase 3
~6120

Find a Location

Who is running the clinical trial?

InxMed (Shanghai) Co., Ltd.Lead Sponsor
10 Previous Clinical Trials
1,195 Total Patients Enrolled
Jun ZhaoPrincipal InvestigatorPeking University Cancer Hospital & Institute
4 Previous Clinical Trials
612 Total Patients Enrolled
~34 spots leftby Jan 2025
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