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Active, Not Recruiting

NCT Number: NCT06494241

Small/Middle Tier Cities and County Lung Cancer Quality Improvement Project (QIP) Study

To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP; To evaluate the treatment pattern in metastatic NSCLC patients after QIP.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Diseases Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Anning, China

Loading trial locations.

About this study

The primary objective of this study is to assess the implementation of standardized diagnosis and treatment practice in oncology departments of Small/Middle tier cities and County hospitals, after standardized education and implementation of lung cancer clinical practice guidelines for oncology physicians.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years, at the time of signing the informed consent.
  • ECOG performance status 0-2.
  • Newly pathologic diagnosed metastatic NSCLC (clinical stage IV) or recurrent metastatic NSCLC.

Exclusion criteria

  • Be participating in other intervention clinical trials.
  • Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
  • Previous enrolment in the other QIP study.

Treatment and study plan

Primary outcomes

  1. To evaluate the molecular testing pattern in metastatic NSCLC patients after QIP

    Time frame: Approximately 1 month after last patient in

    Molecular testing-rate for the first-line treatment: Defined as the number of participants received molecular testing for the first-line treatment divided by total participants.

  2. To evaluate the treatment pattern in metastatic NSCLC patients after QIP

    Time frame: Approximately 1 month after last patient in

    TKIs first-line treatment rate: Defined as TKIs first-line treatment rate in AGA positive participants.

Secondary outcomes

  1. To evaluate the clinical outcomes in metastatic NSCLC patients after QIP

    Time frame: Follow up approximately 24 months after last patient in

    Progression Free Survival (PFS): Defined as the time from beginning of first-line treatment to disease progression or death for any cause, whichever occurs first.

  2. To evaluate the treatment pattern in metastatic NSCLC patients after QIP

    Time frame: Approximately 1 month after last patient in

    1st/2nd/3rd generation EGFR-TKIs first-line treatment rate: Defined 1st/2nd/3rd generation EGFR-TKIs first-line treatment rate in EGFR positive participants.

  3. To evaluate the treatment pattern in metastatic NSCLC patients after QIP

    Time frame: Approximately 1 month after last patient in

    Immunotherapy first-line treatment rate: Defined as PD-1 or PD-L1 inhibitors first-line treatment rate in AGA negative participants.

  4. To evaluate the clinical outcomes in metastatic NSCLC patients after QIP

    Time frame: Follow up approximately 24 months after last patient in

    Response rate: Defined as the percentage of participants with the disease first-line treatment response by investigator assessment as recorded in CRF.

  5. To evaluate the clinical outcomes in metastatic NSCLC patients after QIP

    Time frame: Follow up approximately 24 months after last patient in

    Disease control rate: Defined as the percentage of participants with the disease first-line treatment control by investigator assessment as recorded in CRF

  6. To evaluate the clinical outcomes in metastatic NSCLC patients after QIP

    Time frame: Follow up approximately 24 months after last patient in

    Duration of Response: Defined as the time from first-line treatment response to disease progression or death in participants who achieve responding by investigator assessment as recorded in CRF.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Multi-Center Study to Evaluate the Guideline Education of Oncology Departments in Small/Middle Tier Cities and County Hospitals for Diagnosis and Treatment Improvement in Patients With Metastatic Non-small Cell Lung Cancer

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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