- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00874419
Erlotinib Versus Gemcitabine/Carboplatin in Chemo-naive Stage IIIB/IV Non-Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Exon 19 or 21 Mutation (ML20981)
A Randomized, Open-label, Multi-center Phase III Study of Erlotinib Versus Gemcitabine/Carboplatin in Chemo-naive Stage IIIB/IV Non-Small Cell Lung Cancer Patients With EGFR Exon 19 or 21 Mutation (Optimal)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Primary Outcome Measures:
Progression-free survival(PFS) Secondary Outcome Measures: Overall response rate(ORR), overall survival(OS), quality of life(QOL),etc.
Estimated Enrollment: 160 Study Start Date: August 2008 Estimated Study Completion Date: August 2010
The patients will be randomized into the following two arms:
Arm A: erlotinib 150mg once per day up to disease progression or intolerable toxicity.
Arm B: Gemcitabine (1000mg/m2, IV,d1 and d8) plus Carboplatin (AUC=5, IV d1) repeated every 3 weeks up to 4 cycles.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Shanghai, Kina, 200433
- Medical Department, Shanghai Pulmonary Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Stage IIIB (cytological confirmed with malignant pleural effusion or pericardial effusion) or histopathological or cytological confirmed stage IV NSCLC or relapsed after complete resection .
- EGFR exon19 deletions or exon 21 L858R mutation by the DNA direct PCR sequencing using fresh tumor sample or paraffin embed tumor sample.
- Measurable lesions as defined by RECIST criteria .
- Palliative radiotherapy allowed if it was finished 3 weeks after the first drug administration, but the target lesions should not be included in the radiotherapy field.
- Patients with operation are allowed if the operation is 4 weeks before the first drug administration
- Men or women of at least 18 years of age.
- ECOG Performance status of 0 to 2.
- Estimated life expectancy of at least 12 weeks.
- Patient compliance and geographic proximity that allow adequate follow-up.
Adequate organ function tested 7 days before the first drug administration:
hemoglobin ≥9 g/dL,absolute neutrophil count (ANC) ≥1.5*109/L, platelets ≥100 *109/L,bilirubin ≤1.5ULN, alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 upper limited number(ULN) (AP, AST, ALT ≤5ULN is acceptable if liver has tumor involvement).INR≤1.5, APTT in the normal range( 1.2DLN-1.2ULN),creatinine ≤1.5ULN.
- Informed consent from the patient.
Exclusion Criteria:
- Have received systemic anti-cancer therapy, including Cytotoxic drugs, targeted therapy, experimental treatment, adjuvant or neo-adjuvant therapy(except the disease relapse 6 months after the final drug)
- Wild type EGFR.
- Uncontrolled pericardial or pleural effusions prior to study entry.
- History of cardiovascular disease: Congestive Heart Failure > grade II in NYHA. Unstable angina patients (have angina symptoms in rest) or a new occurrence of angina (began in the last 3 months) or myocardial infarction happens in the last 6 months
- Brain metastasis (controlled brain metastasis and steroid free need is excluded).
- HIV infection
- Active infection, >grade 2 in Common Terminology Criteria for Adverse Events(CTCAE) version 3.
- A history of operation or serious traumatic 3 weeks before the first drug administration
- Patient with other malignant tumor except NSCLC 5 years previous to study entry. Excluding cervical carcinoma in situ, cured basal cell carcinoma, bladder epithelial tumor [including Ta and Tis]
- Mixed with small cell lung cancer
- Unable to swallow drugs.
- Malabsorption
- Pregnant or child breast feeding women
- Childbearing patients will not use a reliable method of contraception before the study entry, during process of the study and within 30 days after discontinuation of the study. Reliable contraceptive methods will be determined by principal investigator or a designated officer.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: erlotinib
Arm 1 receive erlotinib 150 mg oral, once a day until progression or unacceptable toxicity
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erlotinib 150 mg oral, once a day
Andre navne:
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Aktiv komparator: gemcitabine/carboplatin
gemcitabine 1000mg/m2 on d1,8 with carboplatin AUC=5 on d1 intravenously, every 3 weeks, up to 4 cycles
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gemcitabine 1000mg/m2 on d1,8 with carboplatin AUC=5 on d1 intravenously, every 3 weeks, up to 4 cycles
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Progressionsfri overlevelse
Tidsramme: 12 måneder
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12 måneder
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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OS
Tidsramme: 24 months
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24 months
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ORR
Tidsramme: 24 months
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24 months
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Time to Progression
Tidsramme: 24 months
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24 months
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lung cancer symptoms and health-related quality of life (HRQoL)
Tidsramme: 24 months
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24 months
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explore the biological markers (tumor tissue)
Tidsramme: 24 months
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24 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Caicun Zhou, MD & PhD, Tongji University
Publikationer og nyttige links
Generelle publikationer
- Zhou C, Wu YL, Chen G, Feng J, Liu XQ, Wang C, Zhang S, Wang J, Zhou S, Ren S, Lu S, Zhang L, Hu C, Hu C, Luo Y, Chen L, Ye M, Huang J, Zhi X, Zhang Y, Xiu Q, Ma J, Zhang L, You C. Final overall survival results from a randomised, phase III study of erlotinib versus chemotherapy as first-line treatment of EGFR mutation-positive advanced non-small-cell lung cancer (OPTIMAL, CTONG-0802). Ann Oncol. 2015 Sep;26(9):1877-1883. doi: 10.1093/annonc/mdv276. Epub 2015 Jul 3.
- Zhou C, Wu YL, Chen G, Feng J, Liu XQ, Wang C, Zhang S, Wang J, Zhou S, Ren S, Lu S, Zhang L, Hu C, Hu C, Luo Y, Chen L, Ye M, Huang J, Zhi X, Zhang Y, Xiu Q, Ma J, Zhang L, You C. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2011 Aug;12(8):735-42. doi: 10.1016/S1470-2045(11)70184-X. Epub 2011 Jul 23.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Proteinkinasehæmmere
- Gemcitabin
- Carboplatin
- Erlotinib hydrochlorid
Andre undersøgelses-id-numre
- ML20981
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 .
Kliniske forsøg med Ikke-småcellet lungekræft
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AHS Cancer Control AlbertaCross Cancer InstituteAfsluttetOmfattende Stage Small Cel Lung CancerCanada
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Universitaire Ziekenhuizen KU LeuvenUkendtLymfom | Hodgkin lymfom | Non-Hodgkin lymfom (follikulært, diffust B-cel lymfom, PTLD og Mantle Cel lymfom)Belgien
Kliniske forsøg med erlotinib
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National Cancer Institute (NCI)University of Chicago; City of Hope Medical Center; University of Southern... og andre samarbejdspartnereAfsluttet
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PfizerAfsluttetKarcinom, ikke-småcellet lungeForenede Stater
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Fox Chase Cancer CenterMillennium Pharmaceuticals, Inc.AfsluttetIkke-småcellet lungekræft Metastatisk | Ikke-småcellet lungekræft tilbagevendendeForenede Stater
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M.D. Anderson Cancer CenterAfsluttetAvancerede kræftformerForenede Stater
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Grupo de Investigación Clínica en Oncología RadioterapiaAfsluttetPlanocellulært karcinom i hoved og halsSpanien
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University of ChicagoNational Cancer Institute (NCI)AfsluttetMalignt peritoneal mesotheliomForenede Stater
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Merck Sharp & Dohme LLCAfsluttet
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National Cancer Institute (NCI)AfsluttetCervikal planocellulært karcinom | Tilbagevendende livmoderhalskræftForenede Stater
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National Cancer Institute (NCI)AfsluttetStadie IIIB Ikke-småcellet lungekræft | Tilbagevendende ikke-småcellet lungekræft | Stadie IV Ikke-småcellet lungekræftForenede Stater
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National Cancer Institute (NCI)AfsluttetAdenocarcinom i den gastroøsofageale forbindelse | Planocellulært karcinom i spiserøret | Adenocarcinom i spiserøret | Tilbagevendende kræft i spiserøret | Stadium IV Spiserørskræft | Stadie III SpiserørskræftForenede Stater