Zorifertinib With Osimertinib for NSCLC With Meningeal Progression

Sponsor
Alpha Biopharma (Jiangsu) Co., Ltd.
Study ID
NCT07361705
Phase
PHASE1
Status
Recruiting
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Conditions

  • Patients With Advanced Non-small Cell Lung Cancer With Meningeal Progression After Osimertinib Treatment

Eligibility Criteria

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

Interventions

  • Zorifertinib and Osimertinib Combination Therapy — DRUG
    Zorifertinib is an oral tablet (50 mg or 100 mg). Osimertinib is an oral tablet (80 mg). In this Phase 1 study, all participants will receive the combination. Osimertinib is given at a fixed dose of 80 mg once daily. Zorifertinib is given twice daily, with dose levels under evaluation (starting at 100 mg BID, potentially escalating to 150 mg BID, 200 mg BID, or higher). Dose escalation follows a "3+3" design based on dose-limiting toxicity (DLT) assessment in the first 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or meeting other discontinuation criteria.

Study Details

This is a clinical trial that aims to test Zorifertinib when used together with a known drug, Osimertinib. The goal is to learn if this combination is safe and works for people with advanced Non-Small Cell Lung Cancer (NSCLC) whose cancer has spread to the membranes surrounding the brain and spinal cord (a condition called leptomeningeal metastases) after being treated with Osimertinib.

Key Dates

First listed
Jan 23, 2026
Start date
Jan 31, 2026
Status verified
Jun 2026
Primary completion
Apr 23, 2028
Completion
Sep 15, 2028

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Zorifertinib + Osimertinib (Dose Escalation)
    All enrolled participants will receive the investigational combination therapy of Zorifertinib and Osimertinib. This is a Phase 1 study consisting of a dose escalation part (Part A) and a dose expansion part (Part B). In Part A, Zorifertinib dose will be escalated (starting at 100 mg twice daily) alongside a fixed dose of Osimertinib (80 mg once daily) using a "3+3" design to determine the recommended dose. In Part B, additional participants will receive the combination at the recommended dose to further evaluate safety, efficacy, and pharmacokinetics. Treatment continues until disease progression, unacceptable toxicity, or meeting other discontinuation criteria.

Primary Outcome Measure

Determination of Recommended Dose Based on Incidence of Dose-Limiting Toxicities (DLTs) [ Time Frame: During the first 21 days of continuous administration for each participant in the dose-escalation phase. ]

Central Contacts