A Survival Observational Study in Patients With Advanced IIIB-IV Squamous Cell Lung Cancer Receiving PD-1 Combination With Chemotherapy
A Survival Observational Study in Patients With Advanced IIIB-IV Squamous Cell Lung Cancer Receiving PD-1 Combination With Chemotherapy (RESPONSE)
This is a multi-center, open-label, non-interventional, retrospective registry study, with no pre-set statistical assumptions and will not intervene subject's clinical treatment or clinical management.
In the study, the clinical data of the subjects will be retrospectively collected from the electronic health records (EHR) of each research center. The clinical information will be based on the actual medical records of the cases. After the retrospective study time (June 30, 2020), patients will be followed for one-year and two-year survival. Clinical treatment and management will be based on local clinical practices and regulations. This study will record the actual diagnosis and treatment, and will not interfere with any clinical decision.
After subject-out, patients will be followed for one-year and two-year survivals, thus the follow-up consent will be exempted. All patients receiving PD-1 monoclonal antibody in combination with chemotherapy will be visited during the entire study period. At the end of study, investigator will check up on the conditions of patients who withdraw from the study.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
-
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Guangdong
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Guangzhou, Guangdong, Kina, 510080
- Guangdong Provincial People's Hospital
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Men and woman, aged over 18
- Cytology or histologically confirmed squamous cell lung cancer
- Advanced squamous cell lung cancer, Stage IIIb to IV according to AJCC staging (version 8)
- Patients receiving approved PD-1 mAb in combination with chemotherapy according to their condition
- Patients receiving PD-1 mAb in combination with chemotherapy for at least one cycle (21 days)
- Have imaging results with measurable tumor 2 weeks before receiving PD-1 mAb in combination with chemotherapy
- Able to understand and comply with the requirements of the consent and voluntarily participate in the study
Exclusion Criteria:
- Patients participating in other clinical studies
- Severe medical data missing
- Unable to understand the purpose of the study or not agree with the requirement of the study
- Malignancies other than squamous cell lung cancer, history of malignancies
- Unsuitable for the study according to investigator
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Treatment
Patients diagnosed with primary stage IIIB-IV squamous cell lung cancer and treated in 92 medical centers between 01 September 2019 and 30 June 2020 will be targeted for study inclusion.
|
Nivolumab or Pembrolizumab
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
objektiv svarprocent
Tidsramme: 2 år
|
2 år
|
|
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2 års overlevelsesrate
Tidsramme: 2 år
|
2 år
|
|
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median progressionsfri overlevelse
Tidsramme: 2 år
|
2 år
|
|
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disease control rate
Tidsramme: 2 years
|
free survival
|
2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
incidence of adverse reactions
Tidsramme: 2 years
|
Safety of the combination of PD-1 and chemotherapy
|
2 years
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CTONG1904
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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