Andamertinib as First-line Treatment for NSCLC With EGFR PACC or EGFR L861Q Mutation

NCT ID: NCT07336732

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2029-01-31

Brief Summary

This study is an open-label, multicenter phase IIclinical trial designed to evaluate the efficacy, safety, and tolerability of Andamertinib (phase II) in previously untreated participants with locally advanced or metastatic non-squamous NSCLC harboring EGFR PACC mutations or EGFR L861Q mutations.

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).

Conditions

Non-Small-Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PLB1004 given alone as monotherapy

PLB1004 is a capsule in the form of 80mg and 40mg

Group Type: EXPERIMENTAL

PLB1004

Intervention Type: DRUG

PLB1004 is a capsule in the form of 80mg and 40mg

Interventions

PLB1004

PLB1004 is a capsule in the form of 80mg and 40mg

Intervention Type: DRUG

Eligibility Criteria

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 presence of EGFR PACC mutation or EGFR L861Q 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.

11. 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

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.).

11. History or presence of interstitial lung disease, or drug/radiation-related pneumonitis.

12. Active autoimmune or inflammatory diseases.

13. Active, uncontrolled infection (including HBV, HCV, HIV, syphilis, tuberculosis, etc.).

14. Gastrointestinal disorders or surgery affecting drug ingestion or absorption.

15. Active keratitis or ulcerative keratitis.

16. History of hypersensitivity to the study drug, its analogs, or chemotherapy drugs (pemetrexed/platinum agents).

17. Recent administration (within 30 days) of a live attenuated vaccine.

18. Psychiatric disorders or substance abuse potentially affecting compliance.

19. Any other condition deemed by the investigator as unsuitable for study participation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avistone Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PLB1004-II/III-01

Identifier Type: -

Identifier Source: org_study_id