Real World Study in Locally Advanced or Metastatic NSCLC Patients, Progressed From First-line EGFR-TKI Therapy

NCT ID: NCT04207775

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-30

Study Completion Date

2023-09-01

Brief Summary

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To estimate parameters associated with treatment patterns and related clinical outcomes.Including physician reported PFS and OS.

Detailed Description

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The objectives of this study are to assess molecular testing, treatment patterns, and associated clinical outcomes among patients with epidermal growth factor receptor (EGFR) mutation-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed from first-line EGFR-TKI (tyrosine kinase inhibitor) therapy. This study is descriptive in nature and does not attempt to test any specific a priori hypotheses

Conditions

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Locally Advanced or Metastatic NSCLC

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NSCLC

Patients with confirmed EGFR mutation-positive, locally advanced or metastatic NSCLC, who have progressed from first line EGFR-TKI therapy who will receive different treatment

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Male or female patients with age ≥18 years old
2. Histologically or cytologically confirmed locally advanced or metastatic NSCLC patients
3. Patients with prior confirmed EGFR mutation-positive, who have progressed from first line EGFR-TKI\*
4. Provision of written informed consent by the patient should be within 6 weeks of the date of progression from first line EGFR-TKI treatment \*Note:

1. First-line EGFR-TKI is monotherapy;
2. EGFR-TKI has been launched in China includes first-generation, second-generation or third-generation EGFR-TKI, but not including the original chemical compound
3. Exclude the Chinese traditional medicine that is being used to treat lung cancer
4. Progression was determined according to Recist1.1 criteria.

Exclusion Criteria

1. Involvement in the planning and/or conduct of the other intervention study
2. Previous enrolment in the present study
3. Pregnancy or breast-feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Weimin Li, Doctor

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

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Research Site

Beijing, , China

Site Status

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Changsha, , China

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Chengdu, , China

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Chengdu, , China

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Guangzhou, , China

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Guangzhou, , China

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Hangzhou, , China

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Harbin, , China

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Hohhot, , China

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Qingdao, , China

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Shenyang, , China

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Suzhou, , China

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Taizhou, , China

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Xi'an, , China

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Xi'an, , China

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Zhuji, , China

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Countries

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China

References

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Tian P, Wu L, Zhou C, Tan J, Wang K, Luo F, Liu Y, Guo Y, Li Y, Liu Z, Gong Y, Wang Y, Xian J, Li W. Molecular testing, treatment patterns, and outcomes in EGFR-mutated non-small cell lung cancer: the PISCES study. Future Oncol. 2025 Aug;21(19):2537-2547. doi: 10.1080/14796694.2025.2529094. Epub 2025 Jul 28.

Reference Type DERIVED
PMID: 40717496 (View on PubMed)

Other Identifiers

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D5160R00031

Identifier Type: -

Identifier Source: org_study_id

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