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

18. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Hospital-based

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andet: Observation
The patients' second-line treatment received and the follow-up observations were retrospectively collected.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Response Rate
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Efterforskere

  • Ledende efterforsker: Jianchun Duan, M.D., Cancer Hospirtal Chinese Academy of Medical Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

30. juni 2027

Datoer for studieregistrering

Først indsendt

12. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. maj 2026

Først opslået (Faktiske)

19. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCC-021875

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Lungekræft (NSCLC)

Kliniske forsøg med Observation

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Betingelser

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