Trials / Recruiting
RecruitingNCT05994131
IN10018 Combination Therapy in Advanced EGFR Mutation-positive NSCLC
A Multicenter, Open-label, Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerance, Pharmacokinetics and Anti-tumor Efficacy of IN10018 Combined With Third-generation EGFR-TKI in Patients With Advanced EGFR Mutation-positive NSCLC
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- Sponsor
- InxMed (Shanghai) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This study includes 2 parts: Phase Ib-Dose Confirmation and Phase II-Dose Expansion. And 3 cohorts are set up in this study as cohort 1 to enroll subjects currently accepting third-generation EGFR-TKI (Furmonertinib is proposed) as first-line treatment, cohort 2 to enroll subjects who previously accepted third-generation EGFR-TKI treatment and 1-2 lines chemotherapy, and cohort 3 to enroll treatment-naive advanced EGFR mutation-positive NSCLC subjects. The phase Ib-dose confirmation part will be conducted in cohort 2 and aim to determine the recommended phase II dose (RP2D) of IN10018 in combination with Furmonertinib. Phase II-Dose Expansion part will be conducted in cohort 1-3 and further explore the antitumor efficacy, safety and PK of IN10018 in combination with Furmonertinib in subjects with previously-treated or naïve advanced EGFR mutation-positive NSCLC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IN10018 | orally taken once daily |
| DRUG | Furmonertinib | orally taken once daily |
Timeline
- Start date
- 2023-07-13
- Primary completion
- 2026-07-31
- Completion
- 2026-07-31
- First posted
- 2023-08-16
- Last updated
- 2025-04-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05994131. Inclusion in this directory is not an endorsement.