Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07596524

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Hospirtal, Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

observation

Other

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

Primary outcomes

  1. Overall Survival

    Time frame: Time from 2nd line treatment initiation to patient death from any cause, assessed up to 60 months

    The overall survival time of the patients enrolled.

  2. 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

    The time of disease progression free survival.

Secondary outcomes

  1. Objective Response Rate

    Time frame: From 2nd line treatment initiation, assessed up to 24 months

    Overall response rate

  2. Disease control rate

    Time frame: From 2nd line treatment initiation, assessed up to 24 months

    Disease control rate

  3. Immune-related adverse events

    Time frame: From 2nd line treatment initiation and before 3rd line treatment, assessed up to 24 months

    Immune-related adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Jianchun Duan, M.D.

CONTACT

[email protected]

+8610-87788029

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 19, 2026
Registry last updated
May 19, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.