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NCT06030258

IN10018 Combination Therapy in Treatment-naïve ES-SCLC

StatusActive, Not Recruiting
PhasePhase 1/2
Primary completion
Track this trial

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Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 28 words Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Primary completion date changed from estimate of Dec 24, 2025 to Nov 20, 2025
    • Study completion pushed from Dec 24, 2025 to Jan 31, 2027
    • Secondary endpoints: details revised at 3 of 13 entries
    • Site details revised at 3 of 3 sites
  2. Primary and study completion dates pushed to Dec 24, 2025v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 5, 2023 to Oct 30, 2023
    • Site details revised at 3 of 3 sites
    v3
  4. Primary endpoints revised (2)v2
  5. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

To identify the Recommended phase II dose (RP2D) of IN10018 in combination with Tislelizumab, Carboplatin and Etoposide in first-line ES-SCLC.
Timeframe: Up to 3 years
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
Timeframe: Up to 3 years

Secondary (13)

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
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.
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.
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
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.
Show 8 moreShow less
Number of patients with adverse event
PK: AUC of IN10018 following single dose administration and at steady state
PK: Cmax of IN10018 following single dose administration and at steady state
PK: Ctrough of IN10018 following single dose administration and at steady state
PK: Tmax of IN10018 following single dose administration and at steady state
PK: t1/2 of IN10018 following single dose administration and at steady state
PK: CL/F of IN10018 following single dose administration and at steady state
PK: Vd/F of IN10018 following single dose administration and at steady state

Arms and interventions

Experimental groupExperimental

IN10018 in combination with Tislelizumab, carboplatin and etoposide as the first-line treatment in ES-SCLC.

Control groupActive comparator

Tislelizumab in combination with carboplatin and etoposide as the first-line treatment in ES-SCLC

Drugs: IN10018, Tislelizumab, Carboplatin, Etoposide

Sites

3 sites in 1 country