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

ConditionLung Cancer (NSCLC)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Hospital-based

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Observation

    Other intervention

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

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Observation1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival

The overall survival time of the patients enrolled.

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

Progression Free Survival

The time of disease 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 outcomes

1

Objective Response Rate

Overall response rate

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

Disease control rate

Disease control rate

Time frame
From 2nd line treatment initiation, assessed up to 24 months
3

Immune-related adverse events

Immune-related adverse events

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: