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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07596524
Enrollment
300
Registered
2026-05-19
Start date
2026-07-01
Completion date
2027-06-30
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer (NSCLC)

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.

Interventions

OTHERObservation

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

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall SurvivalTime from 2nd line treatment initiation to patient death from any cause, assessed up to 60 monthsThe overall survival time of the patients enrolled.
Progression Free SurvivalTime 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 monthsThe time of disease progression free survival.

Secondary

MeasureTime frameDescription
Objective Response RateFrom 2nd line treatment initiation, assessed up to 24 monthsOverall response rate
Disease control rateFrom 2nd line treatment initiation, assessed up to 24 monthsDisease control rate
Immune-related adverse eventsFrom 2nd line treatment initiation and before 3rd line treatment, assessed up to 24 monthsImmune-related adverse events

Countries

China

Contacts

CONTACTJianchun Duan, M.D.
duanjianchun79@163.com+8610-87788029
PRINCIPAL_INVESTIGATORJianchun Duan, M.D.

Cancer Hospirtal Chinese Academy of Medical Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026