IN10018 Combination Therapy in Advanced EGFR Mutation-positive NSCLC

Sponsor
InxMed (Shanghai) Co., Ltd.
Study ID
NCT05994131
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IN10018 — DRUG
    orally taken once daily
  • Furmonertinib — DRUG
    orally taken once daily

Study Details

This is a multicenter, open-label, phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetics and antitumor efficacy of IN10018 in combination with third-generation EGFR-TKI (Furmonertinib is the proposed) in previously-treated or naïve advanced EGFR-mutation positive NSCLC.

Key Dates

Start date
Jul 13, 2023
Status verified
Apr 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Group in cohort 1, cohort 2, and cohort 3
    IN10018+Furmonertinib
  • Active Comparator: Control Group in cohort 3
    Furmonertinib

Primary Outcome Measure

Recommended phase II dose (RP2D) of IN10018 in combination with third-generation EGFR-TKI in subjects with advanced EGFR mutation-positive NSCLC. [ Time Frame: 3 years ]

Central Contacts

Related Studies