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Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

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

NCT07336732•Avistone Biotechnology Co., Ltd.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years at the time of ICF signing.
•2. Histologically or cytologically confirmed, unresectable locally advanced (Stage IIIB or IIIC) or metastatic (Stage IV) non-squamous non-small cell lung cancer (NSCLC).
•3. Confirmed EGFR atypical mutation.
•4. No prior systemic therapy for locally advanced or metastatic NSCLC.
•5. At least one measurable lesion as defined by RECIST v1.1.
•6. ECOG PS ≤1.
•7. Life expectancy≥12 weeks.
•8. Adequate organ function confirmed within 7 days prior to the first dose of study treatment
•9. 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.
•10. Non-sterilized males: Abstinence or contraception use; No sperm donation.
+1 more criteria

Exclusion Criteria

•1. Presence of specific genetic alterations for which approved targeted therapies are available.
•2. Recent participation (within 28 days) in another interventional clinical trial.
•3. Major surgery within 28 days prior to study entry or planned during the study period.
•4. Recent use of anti-tumor traditional proprietary medicine or local anti-tumor therapy.
•5. Need for specific concomitant medications (e.g., metformin) that cannot be paused during the study.
•6. History of another active malignancy within the past 5 years (except for specific cured cancers).
•7. Toxicities from prior therapy have not recovered to acceptable levels.
•8. Presence of symptomatic or uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression.
•9. Symptomatic and uncontrolled third-space fluid accumulations (e.g., pleural effusion, ascites).
•10. Severe cardiovascular/cerebrovascular disease or risk factors (e.g., heart failure, history of myocardial infarction, QT prolongation, uncontrolled hypertension, etc.).
+9 more criteria

Locations (1)

Sun Yat-Sen University Cancer Center

Guangzhou, China

Key Dates

Start Date

March 11, 2026

Primary Completion Date

November 1, 2026

Completion Date

January 1, 2029

Last Updated

March 20, 2026

Enrollment

ESTIMATED participants

Conditions

Non-Small-Cell Lung Cancer

Interventions

PLB1004

DRUG

Contacts

Haimeng Li

CONTACT

+86 17610831060 lihaimeng@pearlbio.cn

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NCT05568212

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RECRUITINGPHASE2

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NCT06574347

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RECRUITINGPHASE2/PHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Andamertinib With or Without Platinum-doublet Chemotherapy Versus Platinum-doublet Chemotherapy in Patients With NSCLC Harboring Atypical EGFR Mutations

Inclusion Criteria

Exclusion Criteria

Randomized Trial Comparing Standard of Care Versus Immune- Based Combination in Relapsed Stage III Non-small-cell Lung Cancer (NSCLC) Pretreated With Chemoradiotherapy and Durvalumab

Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.

Hippocampal-Sparing Prophylactic Cranial Irradiation in Pathologically Nodal Positive Non-Small-Cell Lung Cancer

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