NCT07336732
Recruiting
Phase 2
An Open-label, Randomized, Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Harboring Atypical EGFR Mutations Who Have Not Received Prior Systematic Therapy
Avistone Biotechnology Co., Ltd.1 site in 1 country40 target enrollmentStarted: March 11, 2026Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Avistone Biotechnology Co., Ltd.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Overview
Brief Summary
This study is an open-label, randomized, multicenter phase II/III clinical trial designed to evaluate the efficacy, safety, and tolerability of Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy in previously untreated participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR atypical mutations. The study comprises two stages: phase II (dose-exploration stage) and phase III (pivotal study stage)
Detailed Description
This a three-stage study consist a Screening Phase (Day -28 to -1), a Treatment Phase (until treatment discontinuation), and a Follow-up Phase (including end of treatment visit (EOT),end of study visit(EOS), safety follow-up and survival follow-up).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years at the time of ICF signing.
- •Histologically or cytologically confirmed, unresectable locally advanced (Stage IIIB or IIIC) or metastatic (Stage IV) non-squamous non-small cell lung cancer (NSCLC).
- •Confirmed EGFR atypical mutation.
- •No prior systemic therapy for locally advanced or metastatic NSCLC.
- •At least one measurable lesion as defined by RECIST v1.
- •Life expectancy≥12 weeks.
- •Adequate organ function confirmed within 7 days prior to the first dose of study treatment
- •Female participants must use adequate contraceptive measures during study participation and for 90 days after the last dose of study treatment and must not be breastfeeding; female subjects not of childbearing potential must meet at least one of the following criteria at screening: Postmenopausal status; Documentation of irreversible surgical sterilization.
- •Non-sterilized males: Abstinence or contraception use; No sperm donation.
- •Willing and able to provide signed ICF and to comply with all requirements and restrictions listed in the ICF and this study protocol.
Exclusion Criteria
- •Presence of specific genetic alterations for which approved targeted therapies are available.
- •Recent participation (within 28 days) in another interventional clinical trial.
- •Major surgery within 28 days prior to study entry or planned during the study period.
- •Recent use of anti-tumor traditional proprietary medicine or local anti-tumor therapy.
- •Need for specific concomitant medications (e.g., metformin) that cannot be paused during the study.
- •History of another active malignancy within the past 5 years (except for specific cured cancers).
- •Toxicities from prior therapy have not recovered to acceptable levels.
- •Presence of symptomatic or uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression.
- •Symptomatic and uncontrolled third-space fluid accumulations (e.g., pleural effusion, ascites).
- •Severe cardiovascular/cerebrovascular disease or risk factors (e.g., heart failure, history of myocardial infarction, QT prolongation, uncontrolled hypertension, etc.).
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time Frame: Up to 3 years
In phase II，Incidence of Treatment-Emergent Adverse Events (TEAEs)
RP3D
Time Frame: Up to 3 years
In phase II, choose the RP3D per gained safety and efficacy data
RP3D or recommended phase 3 treatment regimen
Time Frame: Up to 3 years
In phase II, choose the RP3D per gained safety and efficacy data
Secondary Outcomes
- Duration of Response(DOR)(up to 3 years)
- Objective Response Rate (ORR)(Up to 3 years)
- Disease Control Rate(DCR)(up to 3 years)
- Progression-Free Survival(PFS)(up to 3 years)
- 6-month Progression-Free Survival Rate(up to 3 years)
- 6-month Overall Survival Rate(up to 3 years)
- Assess the PK characteristics of Andamertinib(On cycle1of day 1and cycle3of day1, samples were collected within 2 hours prior to dosing and 4 hours post-dosing,On Day 1of Cycle 2, Cycle 5, Cycle 7, and all subsequent odd-numbered cycles collected within 2hours prior to dosing(each cycle is 21days))
Investigators
Study Sites (1)
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