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

May 18, 2026 updated by: JIANCHUN DUAN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Cancer Hospirtal, Chinese Academy of Medical Sciences
        • Contact:
    • Guangdong
      • Shenzhen, Guangdong, China, 518116
        • Cancer Hospirtal, Chinese Academy of Medical Sciences, Shenzhen
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Provincial Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hospital-based

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observation
Patients with advanced NSCLC who have received standard first-line immune checkpoint inhibitor therapy and have experienced disease progression. Retrospective case screening and collection were conducted, and follow-up observations were carried out.
Other: Observation
The patients' second-line treatment received and the follow-up observations were retrospectively collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
The time of disease progression free survival.
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

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: From 2nd line treatment initiation, assessed up to 24 months
Overall response rate
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
Disease control rate
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
Immune-related adverse events
From 2nd line treatment initiation and before 3rd line treatment, assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Investigators

  • Principal Investigator: Jianchun Duan, M.D., Cancer Hospirtal Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 18, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC-021875

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Whether IPD will be provided will be determined by the results of subsequent clinical trials. At present, it is impossible to determine.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer (NSCLC)

Clinical Trials on Observation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe