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Not yet recruiting NCT07596524

Analysis of Different Second Line Treatment in Advanced NSCLC Patients Progressing After 1st Line Immune Checkpoint Inhibitor Therapy

— Observational Lung Cancer (NSCLC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observation.
Who it may be relevant to
Registry conditions: Lung Cancer (NSCLC). Basic parameters: from 1 year · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Analysis of Different Treatment Modalities and Clinical Outcomes in Advanced NSCLC Patients Progressing After First-Line Immune Checkpoint Inhibitor Therapy: An Observational Study Based on Real-World Data

Overview

The second-line treatment options in clinical practice for immunotherapy progress are complex. Treatment strategies need to be selected based on different progression patterns. It is difficult to simultaneously explore multiple treatment modalities through previous clinical studies. Observational studies through real-world research can efficiently convert clinical practice data into clinical treatment evidence. This study aims to observe the treatment patterns and clinical outcomes of advanced NSCLC patients who received first-line immunotherapy checkpoint inhibitor treatment after progression, in order to provide guidance for the second-line treatment options for patients with first-line immunotherapy progress.

Interventions

  • Other Observation
    The patients' second-line treatment received and the follow-up observations were retrospectively collected.

Primary outcome measures

  • Overall Survival [Time frame: Time from 2nd line treatment initiation to patient death from any cause, assessed up to 60 months]
  • Progression Free Survival [Time frame: Time from 2nd line treatment initiation to the first recorded progression event in the medical information system (radiographic report or physician assessment) or death from any cause, whichever occurs first, assessed up to 60 months]
Secondary outcome measures (3)
  • Objective Response Rate [Time frame: From 2nd line treatment initiation, assessed up to 24 months]
  • Disease control rate [Time frame: From 2nd line treatment initiation, assessed up to 24 months]
  • Immune-related adverse events [Time frame: From 2nd line treatment initiation and before 3rd line treatment, assessed up to 24 months]

Eligibility criteria

Inclusion criteria

  • Locally advanced or metastatic NSCLC that is not curable and confirmed by histological or cytological examination based on the 8th edition of AJCC staging.
  • Previously received advanced first-line treatment based on immune checkpoint inhibitor drugs.
  • Has a medical record of disease progression during the first-line treatment.
  • Complete clinical and pathological data, such as age, gender, smoking history, primary tumor location, differentiation, metastatic site, and imaging and serological review as required.

Exclusion criteria

  • First-line treatment with immune checkpoint inhibitor drugs was ≤ 2 cycles.
  • Excluding patients with incomplete key baseline and treatment information.
  • Have other potential factors that may affect the study results or result in the premature discontinuation, as determined by the investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

China · 3 centers
  • Cancer Hospirtal, Chinese Academy of Medical Sciences — Beijing
  • Cancer Hospirtal, Chinese Academy of Medical Sciences, Shenzhen — Shenzhen
  • Shanxi Provincial Cancer Hospital — Taiyuan

Identifiers

NCT: NCT07596524 · NCC-021875

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗