Analysis of Different Second Line Treatment in Advanced NSCLC Patients Progressing After 1st Line Immune Checkpoint Inhibitor Therapy
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
1 other identifier
observational
300
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2026
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2026
CompletedFirst Posted
Study publicly available on registry
May 19, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
Study Completion
Last participant's last visit for all outcomes
June 30, 2027
May 19, 2026
May 1, 2026
6 months
May 12, 2026
May 18, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Overall Survival
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
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 Outcomes (3)
Objective Response Rate
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
From 2nd line treatment initiation and before 3rd line treatment, assessed up to 24 months
Study Arms (1)
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.
Interventions
The patients' second-line treatment received and the follow-up observations were retrospectively collected.
Eligibility Criteria
Hospital-based
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Cancer Hospirtal, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Cancer Hospirtal, Chinese Academy of Medical Sciences, Shenzhen
Shenzhen, Guangdong, 518116, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013, China
Biospecimen
Biopsy specimen of the lesion
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianchun Duan, M.D.
Cancer Hospirtal Chinese Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician
Study Record Dates
First Submitted
May 12, 2026
First Posted
May 19, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
May 19, 2026
Record last verified: 2026-05