T790M Mutation Positive 2nd Line STandard of cAre Registry (T-STAR)
6. juli 2015 opdateret af: AstraZeneca
T-STAR - T790M Mutation Positive 2nd Line STandard of cAre Registry
The aim of the study is to collect real world information on patients with locally advanced or metastatic non small cell lung cancer (NSCLC) who progressed after first line treatment with an approved Tyrosine-Kinase Inhibitor (TKI), who are known to be T790M positive and have been prescribed second line platinum-based chemotherapy (Pemetrexed + Cisplatin /Carboplatin).
Studieoversigt
Status
Trukket tilbage
Betingelser
Detaljeret beskrivelse
The study is an observational prospective cohort study that plans to enroll approximately 200 patients worldwide. There are Epidermal Growth Factor Receptor (EGFR) mutations known to be associated with EGFR-targeted TKI sensitivity ( Ex19Del, L858R, L861Q, and G719X). Further tests on biopsied tissue or cytology at progression after treatment with an approved EGFR targeted TKI are used to determine positivity to T790M mutation. Primary objectives of the study are :
- To estimate overall survival
- To estimate disease progression (as assessed and defined by physician)
- To estimate time on treatment by line of therapy
- To describe time to subsequent therapies (or death)
- To describe healthcare resource utilization patterns
- To capture patient reported symptoms, functioning, and health-related quality of life (HRQoL) data using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30) and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 13 items (EORTC QLQ-LC13)
- To describe the use of pemetrexed + cisplatin/carboplatin as the 2nd line treatment
- To describe treatment patterns for 3rd line treatment and beyond
Undersøgelsestype
Observationel
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Barnaul, Den Russiske Føderation
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Saint Petersburg, Den Russiske Føderation
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Saint- Petersburg, Den Russiske Føderation
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Kentucky
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Kentucky, Kentucky, Forenede Stater
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Maryland
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Maryland, Maryland, Forenede Stater
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Pennsylvania
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Langhorne, Pennsylvania, Forenede Stater
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Boulogne Billancourt, Frankrig
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Bretagne, Frankrig
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La Chaussee-Saint-Victor, Frankrig
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Lille, Frankrig
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Pontoise, Frankrig
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Rhone-Alpes, Frankrig
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Saint Quentin, Frankrig
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Groningen, Holland
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Catania, Italien
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Ferrara, Italien
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Messina, Italien
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Modena, Italien
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Napoli, Italien
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Padova, Italien
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Parma, Italien
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Perugia, Italien
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Rome, Italien
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Torino, Italien
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Beijing, Kina
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Changsha, Kina
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Guangzhou, Kina
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Jiangsu, Kina
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Jilin, Kina
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Shanghai, Kina
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Shanghai Ruijin Hospital, Kina
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Sichuan Cancer Hospital, Kina
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Xian, Kina
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Alicante, Spanien
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Badalona, Spanien
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Barcelona, Spanien
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La Coruna, Spanien
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Leon, Spanien
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Lugo, Spanien
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Madrid, Spanien
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Ourense, Spanien
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Pamplona, Spanien
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Santander, Spanien
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Sevilla, Spanien
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Valencia, Spanien
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Vizcaya, Spanien
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LinKou, Taiwan
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Taichung, Taiwan
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Taipei, Taiwan
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Esslingen, Tyskland
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with confirmed EGFRm+, T790M mutation positive, locally advanced or metastatic NSCLC who have been prescribed pemetrexed + cisplatin/carboplatin in accordance with clinical practice after 1st line treatment with approved EGFR-targeted TKI will be selected from approximately 100 sites across 17 countries worldwide.
Beskrivelse
Inclusion Criteria:
- Provision of signed and dated written informed consent prior to any study specific procedure.
- Patients with histologically- or cytologically-documented NSCLC who present with Stage IIIB/ Stage IV disease.
- Evidence of radiological disease progression following 1st line treatment for advanced/metastatic NSCLC with an approved EGFR-targeted TKI monotherapy without any additional concurrent NSCLC treatment. Chemotherapy received in the adjuvant setting is permitted.
- Patients prescribed platinum based doublet chemotherapy (pemetrexed + cisplatin/carboplatin) for 2nd line treatment of NSCLC. Treatment must have been selected by physician as part of routine standard of care, prior to confirming eligibility for the study. Patient must be enrolled into the study within two cycles of beginning treatment. Treatment must be given in accordance with local prescribing information.
- Confirmation prior to enrolment into the study that the tumour harbours the following EGFR mutations known to be associated with EGFR-targeted TKI sensitivity: Ex19Del, L858R, L861Q, and G719X.
- Patients must have had confirmation that tumour is T790M mutation positive from a biopsy or cytology sample taken after confirmed disease progression on 1st line treatment with an approved EGFR-targeted TKI.
- WHO performance status 0-1 with no deterioration over the previous 2 weeks and a minimum life expectancy of 12 weeks.
Exclusion Criteria:
Treatment with any of the following:
- Prior treatment with more than one line of treatment for advanced NSCLC.
- Major surgery (excluding placement of vascular access) within 4 weeks prior to enrolment.
- Palliative radiotherapy with a limited field of radiation within 1 week prior to enrolment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation which must be completed within 4 weeks prior to enrolment.
- Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to enrolment.
- Patients who are known to be entering an alternative interventional clinical study at the time of enrolment into this study will be excluded. However, inclusion in this study does not preclude participation in any other clinical study after enrolment. Patients who participate in clinical studies after enrolment into this study will be followed to the extent possible as permitted by the sponsor of that clinical study.
- Involvement in the planning and conduct of the study (applies to AstraZeneca staff or staff at the site).
- Judgment by the physician that the patient should not participate in the study if the patient is unlikely to comply with procedures, restrictions, and requirements.
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 |
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NSCLC T790M positive
NSCLC patients who have had 1st line treatment with an approved EGFR targeted TKI, who are known to be T790M mutation positive and who have been prescribed platinum based doublet chemotherapy (pemetrexed + cisplatin/carboplatin) as a 2nd line treatment as part of their standard care.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Overall Survival
Tidsramme: 24 months from last subject in
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This will be assessed as the time from the start date of 2nd line chemotherapy until death due to any cause or censoring (at end of 24 months).To assess efficacy of permetrexed + cisplatinum/carboplatin as the 2nd line of treatment of NSCLC.
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24 months from last subject in
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Respons på terapi som vurderet af lægen
Tidsramme: 24 måneder fra sidste emne i
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Dette vil blive vurderet som tiden fra start af 2. liniebehandling til datoen for sygdomsprogression eller død (af enhver årsag i fravær af progression).
At vurdere effektiviteten af 2. linje behandling og videre.
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24 måneder fra sidste emne i
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Tid til behandling efter terapilinje og mellem behandlinger
Tidsramme: 24 måneder fra sidste emne i
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Dette vil blive vurderet som tiden fra startdatoen for behandlingslinjen til slutdatoen for behandlingslinjen eller dødsdatoen.
At beskrive behandlingsmønstre for 2. linje og videre.
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24 måneder fra sidste emne i
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Tid til symptomforværring
Tidsramme: 24 måneder fra sidste emne i
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For hvert af symptomerne i EORTC QLQ-LC13 og EORTC QLQ-C30, Tid fra inklusion indtil datoen for første klinisk betydningsfulde symptomforværring eller død af en hvilken som helst årsag i fravær af en klinisk meningsfuld symptomforværring.
At vurdere virkningen af 2. og efterfølgende behandlingslinjer på patienters sygdomsrelaterede symptomer og sundhedsrelaterede livskvalitet.
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24 måneder fra sidste emne i
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Symptomforbedringsrate
Tidsramme: 24 måneder fra sidste emne i
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Dette vil blive vurderet som antallet af patienter med to på hinanden følgende vurderinger, som viste en klinisk meningsfuld forbedring af dette symptom fra baseline.
At vurdere virkningen af 2. og efterfølgende behandlingslinjer på patienters sygdomsrelaterede symptomer og sundhedsrelaterede livskvalitet.
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24 måneder fra sidste emne i
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Admission of planned/unplanned hospitalizations, emergency department visits and outpatient/physician visits
Tidsramme: 24 months from last subject in
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This will be assessed as the number and Time from the dates of admission and exit of attendance.
To describe Healthcare resource utilization for 2nd line treatment and beyond.
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24 months from last subject in
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Duration of Response as defined by the physician
Tidsramme: 24 months from last subject in
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This will be assessed as the time from the date of complete or partial response until the first date of recurrence or progression.
To assess the efficacy of 2nd line treatment and beyond.
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24 months from last subject in
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Progression Free Survival
Tidsramme: 24 months from last subject in
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This will be assessed as the time from start of 2nd line therapy until the date of disease progression or death by any cause.
This will be done to assess efficacy of pemetrexed + cisplatin/carboplatin as the 2nd line treatment of NSCLC.
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24 months from last subject in
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
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
1. juni 2015
Primær færdiggørelse (Forventet)
1. juni 2018
Studieafslutning (Forventet)
1. juni 2018
Datoer for studieregistrering
Først indsendt
29. januar 2015
Først indsendt, der opfyldte QC-kriterier
17. februar 2015
Først opslået (Skøn)
23. februar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. juli 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. juli 2015
Sidst verificeret
1. juli 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D5160R00001
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .