A Phase Ⅱ Study Assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins Mutation Patients With Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC)

NCT06015503 | Recruiting Phase 2

• 1 other identifier: PLB1004-II-01
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

It is a phase Ⅱ,open-label, single-line, Multiple cohorts, Multicenter study assessing the Safety and Efficacy of PLB1004 in EGFR ex20ins mutation patients with Advanced and Metastatic Non-small Cell Lung Cancer(NSCLC).

Conditions

Non-Small-Cell Lung Cancer

Keywords

Non-Small-Cell Lung Cancer; EGFR; NSCLC; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• objective Response Rate (ORR)

  To evaluate the Objective Response Rate（ORR）which is defined by IRC as the proportion of subjects with confirmed best overall response of complete response or partial response per RECIST v 1.1.

  3 years

Secondary Outcomes (18)

• objective Response Rate (ORR)

  3 years

• Disease Control Rate ( DCR)

  3 years

• Duration of Response (DOR)

  3 years

• Progression-Free Survival (PFS)

  3 years

• Overall Survival (OS)

  3 years

Study Arms (1)

PLB1004

EXPERIMENTAL

PLB1004 given alone as monotherapy

Drug: PLB1004

Interventions

PLB1004 DRUG

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

PLB1004

Eligibility Criteria

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

You may qualify if:

• Ability to understand and willingness to sign a written informed consent document.
• Aged at least 18 years old.
• Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\~IV).
• According to the prior treatments having received for advanced disease (platinum containing or/and immunotherapy containing systemic therapy, not more than three lines), participants were divided into two cohorts。
• Participants with EGFR ex20ins mutation.
• ECOG performance status 0 to 1.
• Life expectancy is not less than 12 weeks.
• At least one measurable lesion as defined by RECISTV1.1.
• Participants must have specific organ and bone marrow function.

You may not qualify if:

• Having the anticancer therapy prior to the first dose of PLB1004 as follows:
• Any monoclonal antibodies targeting EGFR/HER2/VEGFR within 4 weeks.
• Any cytotoxic drugs or other anticancer drugs from a previous treatment regimen within 14 days.
• Any anticancer herbal medicine within 7 days
• Major surgery within 4 weeks prior to starting PLB1004 or who have not recovered from side effects of such procedure except for the biopsy of Thoracoscopy and the clinical test of Mediastinoscopy could ≤ 7 days prior to starting PLB1004..
• Radiotherapy to lung fields and whole-brain fields ≤4 weeks prior to starting PLB1004. For all other anatomic sites, radiotherapy ≤2 weeks prior to starting PLB1004 or patients who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions is not included.
• Any anti-EGFR TKI for the EGFR ex20ins mutation.
• Any third-generation anti-EGFR TKI during the treatment having achieved a best overall response of the partial response or complete response.
• Had not recovered from the adverse events and comorbidities caused by prior Systemic chemotherapy ,surgery ,radiotherapy to ≤ Grade 1（except for hair loss and permanent radiotherapy damage ）,the neurological toxicity caused by platinum could ≤ Grade 2.
• Patients receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least 1 week prior to the start of treatment with PLB1004 and for the duration of the study:
• Strong inhibitors of CYP3A4
• Strong inducers of CYP3A4
• metformin a MATE transporter substrate
• Patients with spinal cord compression ,brain membrane metastasis and symptomatic central nervous system (CNS), who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study manage CNS symptoms.
• Patients with uncontrolled and symptomatic pleural effusions, peritoneal effusions and pericardial effusions within 4 weeks prior to the start of treatment with PLB1004.

Sponsors & Collaborators

• Avistone Biotechnology Co., Ltd.: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, 510080, 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

Study Officials

• Yilong Wu, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weizhe Xue

CONTACT

+86-010-84148931; xueweizhe@avistonebio.com

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: August 18, 2023
• First Posted: August 29, 2023
• Study Start: July 21, 2023
• Primary Completion: March 6, 2025
• Study Completion: October 30, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)