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NCT05994131

IN10018 Combination Therapy in Advanced EGFR Mutation-positive NSCLC

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

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Record History

All 3 versions: 2 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 32 words Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Primary completion date changed from estimate of Jul 31, 2026 to Sep 20, 2025
    • Study completion pushed from Jul 31, 2026 to Dec 31, 2026
    • Secondary endpoints: details revised at 5 of 12 entries
    • Site details revised
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Recommended phase II dose (RP2D) of IN10018 in combination with third-generation EGFR-TKI in subjects with advanced EGFR mutation-positive NSCLC.
Timeframe: 3 years
ORR of IN10018 in combination with third-generation EGFR-TKI in subjects with advanced EGFR mutation-positive NSCLC.
Timeframe: 3 years
Tumor Shrinkage Rate (TSR) of IN10018 in combination with third-generation EGFR-TKI in cohort 3 of advanced treatment-naive EGFR mutation-positive NSCLC.
Timeframe: 3 years

Secondary (12)

PFS of IN10018 in combination with third-generation EGFR-TKI in advanced EGFR mutation-positive NSCLC.
DOR of IN10018 in combination with third-generation EGFR-TKI in advanced EGFR mutation-positive NSCLC.
DCR of IN10018 in combination with third-generation EGFR-TKI in advanced EGFR mutation-positive NSCLC.
OS of IN10018 in combination with third-generation EGFR-TKI in advanced EGFR mutation-positive NSCLC.
Number of patients with adverse event
Show 7 moreShow less
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 Group in cohort 1, cohort 2, and cohort 3Experimental

IN10018+Furmonertinib

Control Group in cohort 3Active comparator

Furmonertinib

Drugs: IN10018, Furmonertinib

Sites

1 site in 1 country

  • Shanghai Pulmonary HospitalShanghai, China