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

NCT07336732 | Recruiting Phase 2

• 1 other identifier: PLB1004-II/III-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Conditions

Non-Small-Cell Lung Cancer

Keywords

Non-Small-Cell Lung Cance; EGFR; PACC; L861Q; Lung Cancer; EGFR ex20ins

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).

  In phase II，Incidence of Treatment-Emergent Adverse Events (TEAEs)

  Up to 3 years

• RP3D or recommended phase 3 treatment regimen

  In phase II, choose the RP3D per gained safety and efficacy data

  Up to 3 years

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  Up to 3 years

• Duration of Response(DOR)

  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

Study Arms (1)

Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy

EXPERIMENTAL

PLB1004, oral, QD Platinum-based chemotherapy， injection, once every 21-day

Drug: PLB1004

Interventions

PLB1004 DRUG

Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy

Andamertinib with or without platinum-based chemothsrapy versus platinum-based chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 v1.1.
• ECOG PS ≤1.
• 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.

You may not qualify if:

• 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.).
• History or presence of interstitial lung disease, or drug/radiation-related pneumonitis.
• Active autoimmune or inflammatory diseases.
• Active, uncontrolled infection (including HBV, HCV, HIV, syphilis, tuberculosis, etc.).
• Gastrointestinal disorders or surgery affecting drug ingestion or absorption.
• Active keratitis or ulcerative keratitis.

Sponsors & Collaborators

• Avistone Biotechnology Co., Ltd.: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Haimeng Li

CONTACT

+86 17610831060; lihaimeng@pearlbio.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 13, 2026
• Study Start: March 11, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

CN (1)