Pemetrexed og bedste støttende behandling versus placebo og bedste støttende behandling ved ikke-småcellet lungekræft (NSCLC)
17. december 2014 opdateret af: Eli Lilly and Company
En fase 3, dobbeltblind, placebokontrolleret undersøgelse af vedligeholdelse Pemetrexed Plus bedste støttende behandling versus bedste støttende behandling umiddelbart efter induktionsbehandling for avanceret ikke-småcellet lungekræft
Dette studie er et randomiseret fase 3, dobbeltblindt studie af vedligeholdelses-pemetrexed plus bedste understøttende behandling versus placebo plus bedste understøttende behandling ved NSCLC.
Deltagerne skal have modtaget 1 ud af 6 induktionsregimer i 4 cyklusser og ikke have haft progressiv sygdom før randomisering (tilmelding) til dette forsøg.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
663
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New South Wales
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Bankstown, New South Wales, Australien, 2200
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Coffs Harbour, New South Wales, Australien, 2450
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Kogarah, New South Wales, Australien, 2217
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Port Macquarie, New South Wales, Australien, 2444
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Queensland
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Nambour, Queensland, Australien, 4560
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Townsville, Queensland, Australien, 4810
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South Australia
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Ashford, South Australia, Australien, 5035
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Victoria
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Frankston, Victoria, Australien, VIC 3199
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Ijui, Brasilien, 98700 000
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Sao Paulo, Brasilien, 01277-900
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Sofia, Bulgarien, 1527
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Varna, Bulgarien, 9010
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55455
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New Hampshire
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Portsmouth, New Hampshire, Forenede Stater, 03801
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38120
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Texas
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Dallas, Texas, Forenede Stater, 75204
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Wisconsin
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Marshfield, Wisconsin, Forenede Stater, 54449
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Athens, Grækenland, 11527
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Chania, Grækenland, 73300
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Amsterdam, Holland, 1105 AZ
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Ede, Holland, 6716 RP
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Zutphen, Holland, 7207 BA
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Zwolle, Holland, 80211 JW
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Banglagore, Indien, 560034
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Jaipur, Indien, 302017
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Mumbai, Indien, 400 026
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P.O Ernakulam, Indien, 682304
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Trivandrum, Indien, 695 011
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Bari, Italien, 70126
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Bologna, Italien, 40100
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Genova, Italien, 16132
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Livorno, Italien, 57128
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Messina, Italien, 98122
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Padova, Italien, 35128
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Pisa, Italien, 56100
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Rome, Italien, 00168
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Rozzano, Italien, 20089
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Ankara, Kalkun, 06100
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Izmir, Kalkun, 35100
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Beijing, Kina, 100730
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Dalian, Kina, 116023
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Guang Zhou, Kina, 510080
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Hangzhou, Kina, 310016
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Ji Nan, Kina, 250012
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Nan Jing, Kina, 210009
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Shanghai, Kina, 200025
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Seoul, Korea, Republikken, 139-706
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Zagreb, Kroatien, 10000
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Poznan, Polen, 60-569
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Warsaw, Polen, 02-781
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Cluj-Napoca, Rumænien, 3400
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Oradea, Rumænien, 3700
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Alcoi, Spanien, 03804
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Alcorcon, Spanien, 28922
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Barcelona, Spanien, 08003
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Granada, Spanien, 18014
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Mataró, Spanien, 08304
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Murcia, Spanien, 30008
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Palma De Mallorca, Spanien, 07198
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Santa Cruz De Tenerife, Spanien, 38320
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Taipei, Taiwan, 112
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Brno, Tjekkiet, 656 91
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Ostrava-Poruba, Tjekkiet, 708 52
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Prague, Tjekkiet, 128 08
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Hamburg, Tyskland, D-20246
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Hamm, Tyskland, 59071
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Hannover, Tyskland, D-30625
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Magdeburg, Tyskland, D-39120
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Ulm, Tyskland, D-89081
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Mosdos, Ungarn, 7257
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Szombathely, Ungarn, H-9700
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Vienna, Østrig, 1130
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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
Beskrivelse
Inklusionskriterier:
- Histologisk eller cytologisk diagnose af NSCLC trin IIIB (med pleural effusion og/eller positive supraclavikulære lymfeknuder) eller trin IV før induktionsterapi.
- Deltagerne skal have haft 1 af følgende induktionsterapier til behandling af trin IIIB (med pleural effusion og/eller positive supraclavikulære lymfeknuder) eller IV NSCLC: Gemcitabin plus carboplatin, paclitaxel plus carboplatin eller docetaxel plus carboplatin, gemcitabin plus cisplatin, paclitaxel cisplatin eller docetaxel plus cisplatin.
- Deltagerne skal kun have modtaget 1 kemoterapeutisk dublet, der varer præcis 4 cyklusser.
- Induktionsregimer skal være baseret på 21-dages cyklusser.
- Dokumenteret tegn på en tumorrespons med fuldstændig respons (CR), partiel respons (PR) eller stabil sygdom (SD). Tumorvurdering skal finde sted mellem cyklus 4 (dag 1) af induktionsterapi og datoen for randomisering. Dette svar skal ikke bekræftes, for at deltageren kan blive randomiseret. Positron-emissionstomografi (PET)-scanninger og ultralyd må ikke bruges til læsionsmålinger til responsbestemmelse.
Ekskluderingskriterier:
- Med undtagelse af de kemoterapier, der er anført som inklusionskriterier, vil deltagere ikke blive inkluderet, hvis de har modtaget tidligere systemisk anticancerterapi (inklusive adjuverende behandling i tidligt stadium for NSCLC) eller systemisk behandling for enhver anden cancer.
- Har modtaget behandling inden for de sidste 30 dage med et lægemiddel, der ikke har modtaget myndighedsgodkendelse for nogen indikation på tidspunktet for studiestart.
- Manglende evne til at overholde protokol eller undersøgelsesprocedurer.
- En alvorlig samtidig systemisk lidelse, der ville kompromittere deltagerens evne til at gennemføre undersøgelsen.
- En alvorlig hjertelidelse, såsom myokardieinfarkt inden for 6 måneder, angina eller hjertesygdom, som defineret af New York Heart Association Klasse III eller IV.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Pemetrexed og bedste støttende behandling
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500 milligram pr. kvadratmeter (mg/m^2), intravenøs (IV) administration, hver (q) 21. dag, indtil sygdomsprogression
Andre navne:
Behandling uden et specifikt antineoplastisk regime, givet med det formål at maksimere livskvaliteten, vurderet af den behandlende læge.
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Placebo komparator: Placebo og bedste støttende behandling
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Behandling uden et specifikt antineoplastisk regime, givet med det formål at maksimere livskvaliteten, vurderet af den behandlende læge.
IV administration, q 21 dage
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Progressionsfri overlevelsestid (PFS).
Tidsramme: Randomisering til målt PD eller død af enhver årsag (op til 41 måneder)
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PFS-tid var den forløbne tid fra datoen for randomisering til den første dato for objektiv progression af sygdom eller død af enhver årsag.
PFS blev censureret på datoen for deltagerens sidste tumorvurdering for deltagere, som ikke var kendt for at være døde eller at have PD på tidspunktet for datainddragelsesdatoen for analyse.
PD, defineret ved hjælp af responsevalueringskriterier i solide tumorer version 1.0 (RECIST v1.0), var en stigning på mindst 20 % i summen af den længste diameter (LD) af mållæsioner, idet den mindste sum LD registreret siden behandlingen startede som reference. eller fremkomsten af 1 eller flere nye læsioner.
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Randomisering til målt PD eller død af enhver årsag (op til 41 måneder)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Samlet overlevelsestid (OS).
Tidsramme: Randomisering til dødsdato uanset årsag (op til 41 måneder)
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OS-tid var den forløbne tid fra datoen for randomisering til datoen for død af en hvilken som helst årsag.
OS blev censureret på den sidste kontaktdato for deltagere, der ikke var kendt for at være døde på tidspunktet for datainkluderingsdatoen for analyse.
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Randomisering til dødsdato uanset årsag (op til 41 måneder)
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Tid til objektiv progressiv sygdom (TPD)
Tidsramme: Randomisering til målt PD (op til 41 måneder)
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TPD var den forløbne tid fra datoen for randomisering til den første dato for objektiv PD.
TPD blev censureret på datoen for deltagerens sidste tumorvurdering for deltagere, som ikke var kendt for at have PD på tidspunktet for datainddragelsesdatoen for analyse, eller som døde uden objektiv PD.
PD, defineret ved hjælp af RECIST v1.0, var mindst en stigning på 20 % i summen af LD af mållæsioner, idet den mindste sum LD registreret siden behandlingen startede eller fremkomsten af 1 eller flere nye læsioner som reference.
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Randomisering til målt PD (op til 41 måneder)
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Tid til forværring af symptomer (TWS)
Tidsramme: Randomisering til forværring af hver LCSS-vare (op til 39 måneder)
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TWS var den forløbne tid fra datoen for randomisering til den første dato for forværring [defineret som en 15-millimeter (mm) stigning fra baseline baseret på en 100-mm-skala] for hvert symptom og opsummering i Lung Cancer Symptom Scale ( LCSS).
Det deltagerrapporterede LCSS var et spørgeskema med 9 punkter.
Seks punkter var symptomspecifikke mål for lungekræft (tab af appetit, træthed, hoste, dyspnø, hæmoptyse og smerter), og 3 summeringspunkter beskrev total symptomatisk nød, interferens med aktivitetsniveau og global livskvalitet.
Deltager (pt) svar på hvert punkt blev målt ved hjælp af visuelle analoge skalaer (VAS) fra 0 (for bedste resultat) til 100 (for værste resultat).
TWS blev censureret på datoen for den sidste LCSS-vurdering for pts, der ikke var kendt for at have LCSS-forværring.
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Randomisering til forværring af hver LCSS-vare (op til 39 måneder)
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Procentdel af deltagere med en komplet respons (CR) eller delvis respons (PR) (objektiv tumorresponsrate)
Tidsramme: Baseline til målt PD (op til 41 måneder)
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Respons blev defineret ved hjælp af RECIST v1.0 kriterier.
CR blev defineret som forsvinden af alle mållæsioner.
PR blev defineret enten A) et fald på mindst 30 % i summen af LD af mållæsioner med udgangspunkt i baseline summen af LD'er eller B) fuldstændig forsvinden af mållæsioner med persistens (men ikke forværring) af 1 eller flere non-target læsioner .
I begge tilfælde kan der ikke være opstået nye læsioner.
Procentdelen af deltagere med CR eller PR=(Antal deltagere med CR eller PR)/(Antal deltagere vurderet)*100.
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Baseline til målt PD (op til 41 måneder)
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Antal deltagere med uønskede hændelser (AE'er)
Tidsramme: Baseline til studieafslutning (op til 41 måneder)
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Klinisk signifikante hændelser blev defineret som alvorlige bivirkninger (SAE'er) og andre ikke-alvorlige AE'er uanset årsagssammenhæng.
En oversigt over alvorlige og andre ikke-alvorlige bivirkninger, uanset årsagssammenhæng, findes i modulet Rapporterede bivirkninger.
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Baseline til studieafslutning (op til 41 måneder)
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Maksimal forbedring i forhold til baseline i individuelle symptomscore og livskvalitet ved brug af LCSS
Tidsramme: Baseline til og med 30 dage efter seponering af undersøgelsesbehandling (op til 39 måneder)
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Det deltagerrapporterede LCSS var et spørgeskema med 9 punkter.
Seks punkter var symptomspecifikke mål for lungekræft (tab af appetit, træthed, hoste, dyspnø, hæmoptyse og smerter), og 3 summeringspunkter beskrev total symptomatisk nød, interferens med aktivitetsniveau og global livskvalitet.
Deltagersvar på hvert punkt blev målt ved hjælp af VAS fra 0 (for bedste resultat) til 100 (for værste resultat).
Det gennemsnitlige symptombyrdeindeks (ASBI) var gennemsnittet af de 6 symptomspecifikke elementer.
Den samlede LCSS-score var gennemsnittet af de 9 elementer.
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Baseline til og med 30 dage efter seponering af undersøgelsesbehandling (op til 39 måneder)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Belani CP, Brodowicz T, Ciuleanu TE, Krzakowski M, Yang SH, Franke F, Cucevic B, Madhavan J, Santoro A, Ramlau R, Liepa AM, Visseren-Grul C, Peterson P, John WJ, Zielinski CC. Quality of life in patients with advanced non-small-cell lung cancer given maintenance treatment with pemetrexed versus placebo (H3E-MC-JMEN): results from a randomised, double-blind, phase 3 study. Lancet Oncol. 2012 Mar;13(3):292-9. doi: 10.1016/S1470-2045(11)70339-4. Epub 2012 Feb 14.
- Gridelli C, Brodowicz T, Langer CJ, Peterson P, Islam M, Guba SC, Moore P, Visseren-Grul CM, Scagliotti G. Pemetrexed therapy in elderly patients with good performance status: analysis of two phase III trials of patients with nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2012 Sep;13(5):340-6. doi: 10.1016/j.cllc.2011.12.002. Epub 2012 Jan 23.
- Ciuleanu T, Brodowicz T, Zielinski C, Kim JH, Krzakowski M, Laack E, Wu YL, Bover I, Begbie S, Tzekova V, Cucevic B, Pereira JR, Yang SH, Madhavan J, Sugarman KP, Peterson P, John WJ, Krejcy K, Belani CP. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet. 2009 Oct 24;374(9699):1432-40. doi: 10.1016/S0140-6736(09)61497-5. Epub 2009 Sep 18.
Hjælpsomme links
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. marts 2005
Primær færdiggørelse (Faktiske)
1. august 2007
Studieafslutning (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
1. februar 2005
Først indsendt, der opfyldte QC-kriterier
1. februar 2005
Først opslået (Skøn)
2. februar 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. december 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. december 2014
Sidst verificeret
1. december 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Antineoplastiske midler
- Folinsyreantagonister
- Pemetrexed
Andre undersøgelses-id-numre
- 5122
- H3E-MC-JMEN (Anden identifikator: Eli Lilly and Company)
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 .