NCT05598528

Brief Summary

Lung cancer is currently the world's largest malignant tumor for cancer-related deaths with non-small cell lung cancer (NSCLC) accounting for 80%-85%. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), especially the 3rd-generation EGFR-TKIs have demonstrated strong antitumor effects in EGFR-positive patients. However, approximately 20% of EGFR-positive were primarily resistant to 3rd generation EGFR-TKIs, i.e., clinical non-response or disease progression in the short term. This study aimed to clarify the molecular indicators that predict the benefits of 3-rd EGFR-TKIs as first-line therapy in NSCLCpatients with EGFR-positive. Further, to clarify their primary drug resistance mechanisms, which is of great significance for the treatment and clinical decision-making of NSCLC disease.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Sep 2021Dec 2026

Study Start

First participant enrolled

September 28, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

4.3 years

First QC Date

October 25, 2022

Last Update Submit

November 27, 2024

Conditions

Lung Cancer, Non-small CellEGFR Gene MutationEGFR-TKI Resistant MutationPrimary ResistanceCirculating Tumor DNA

Outcome Measures

Primary Outcomes (3)

  • Objective Response Rate (ORR)

    The proportion of patients with a complete response or partial response to treatment according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    2 years

  • Progression-free survival (PFS)

    Time from the beginning of treatment to the first disease progression (PD) in patients with advanced NSCLC

    3 years

  • Differences in genomic profiles of tumor tissues and ctDNA clearance of third-generation EGFR-TKIs sensitive and primary drug-resistant NSCLC.

    The patients who don't achieve partial response or progress within 6 months are defined as the primary resistant group. The genomic profiles and ctDNA clearance detected by Next-generation gene sequencing will be compared between the primary drug-resistant group and sensitive-drug group.

    3 years

Secondary Outcomes (2)

  • Overall survival (OS)

    5 years

  • Disease Control Rate (DCR)

    3 years

Other Outcomes (1)

  • The correlation between tumor microenvironment signature and efficacy of 3rd EGFR-TKIs

    3 years

Study Arms (1)

EGFR-positive lung patients recieving 3rd generation EGFR-TKIs as first-line therapy

Stage III-IV EGFR-positive lung patients receiving 3rd generation EGFR-TKIs (Osimertinib 80mg/Qd or Almonertinib 110mg/Qd or Furmonertinib 80mg/Qd) as first-line therapy.

Other: Genomic profiles detectionOther: circulating tumor DNA detection

Interventions

Genomic profiles detectionOTHER

The Paraffin-embedded tumor tissue at diagnosis is collected and assessed by Next- generation gene sequencing

EGFR-positive lung patients recieving 3rd generation EGFR-TKIs as first-line therapy
circulating tumor DNA detectionOTHER

The Plasma at diagnosis and at 1-month treatment are collected and assessed by Next-generation gene sequencing

EGFR-positive lung patients recieving 3rd generation EGFR-TKIs as first-line therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stage IIIB-IV EGFR-positive lung patients receiving 3rd generation EGFR-TKIs (Osimertinib 80mg/Qd or Almonertinib 110mg/Qd or Furmonertinib 80mg/Qd) as first-line therapy.

You may qualify if:

  • Age \>18 years;
  • Histological or cytopathological diagnosed NSCLC;
  • According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is unresectable IIIB-IV or recurrence and metastasis after surgery;
  • At least one measurable lesion can be evaluated according to the Response Evaluation Criteria In Solid Tumours v1.1 (RECIST1.1) criteria;
  • Positive EGFR mutation confirmed by tissue or cytology (pleural fluid, cerebrospinal fluid, etc.);
  • Use of third-generation EGFR-TKIs approved by the NMPA for NSCLC as first-line therapy;
  • Cooperate with the provision of clinicopathological data, imaging data, sample collection, and follow-up required for the research process, and agree to use the test data for subsequent research and product development;
  • Agree to participate in this study and sign an informed consent form.

You may not qualify if:

  • Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form;
  • Pregnant and lactating women;
  • Other malignant neoplastic diseases within 3 years;
  • Patients who have undergone other clinical drug trials;
  • Received systemic anti-tumor therapy within 2 years;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, The Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. The paraffin embeds tumor tissue at diognosis 2. Peripheral venous blood

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 25, 2022

First Posted

October 28, 2022

Study Start

September 28, 2021

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

December 2, 2024

Record last verified: 2024-11

Locations

CN(1)