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- Klinische proef NCT01953913
Afatinib (BIBW 2992) in Advanced Non-Small Cell Lung Cancer Patients With EGFR Mutation
27 juni 2019 bijgewerkt door: Boehringer Ingelheim
An Open Label, Multicentre, Single Arm Trial to Assess the Safety of Afatinib for Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
Primary objective of the trial is to evaluate the safety of afatinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR (Epidermal growth factor receptor) mutation(s) and have never been treated with an EGFR-TKI (tyrosine kinase inhibitor).
Secondary objective is to assess the time to symptomatic progression (as judged by investigator).
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
542
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Beijing, China, 100071
- 307 Hospital of PLA
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Beijing, China, 100142
- Beijing Cancer Hospital
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Beijing, China, 100853
- Chinese PLA General Hospital
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Changchun, China
- Jilin Province Cancer Hospital
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Guangzhou, China, 510080
- Guangdong Provincial People's Hospital
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Hangzhou, China, 310022
- Zhejiang Cancer Hospital
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Linyi, China, 276002
- Lin Yi Tumor Hospital
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Nanjing, China, 210000
- Jiangsu Cancer Hospital
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Shanghai, China, 200030
- Shanghai Chest Hospital
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Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
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Shanghai, China, 200433
- Shanghai Pulmonary Hospital
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Tianjin, China, 300060
- Tianjin Medical University Cancer Institute and Hospital
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Hong Kong, Hongkong
- Queen Mary Hospital
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Shatin, Hongkong
- Prince of Wales Hospital
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Bangalore, Indië, 560052
- Vikram Hospital
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Bengaluru, Indië, 560027
- HCG Hospital
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Calicut, Indië, 673002
- P VS Hospital Pvt Ltd
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Chennai, Indië, 600031
- V S Hospital
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Delhi, Indië, 110092
- Max Super Speciality Hospital, Delhi
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Hyderabad, Indië, 500004
- Global Hospitals
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Hyderabad, Indië, 500034
- Basavatarakam Indo - American Cancer Hospital & Research Ins
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Jaipur, Indië, 302004
- SEAROC Cancer Centre
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Kolkata,West Bengal, Indië, 700053
- B. P. Poddar Hospital & Medial Research Ltd
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Madurai, Indië, 625 020
- Asirvatham Multispeciality Hospital
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Maharashtra, Indië, 422 004
- Curie Manavata Cancer Centre
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Maharashtra, Indië, 422005
- Shatabdi Superspeciality Hospital
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Mumbai, Indië, 400010
- Prince Aly Khan Hospital
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Pune, Indië, 411001
- Ruby Hall Clinic
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Singapore, Singapore, 169610
- National Cancer Centre
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Kaohsiung, Taiwan, 824
- E-Da Hospital
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Tainan, Taiwan, 704
- NCKUH
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Taipei, Taiwan, 11490
- Tri-Service General Hospital
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Taoyuan County, Taiwan, 333
- Chang-Gung Memorial Hospital, Linkou
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion criteria:
- locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC)
- presence of Epidermal Growth Factor Receptor (EGFR) mutations in tumor biopsy
- male or female patients age 18 years or older (For India only, male or female patients age >=18 years and <=75 years)
adequate organ function, defined as all of the following:
- Absolute Neutrophil Count (ANC) > 1500/mm3. (ANC >1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
- Platelet count >75,000/mm3
- Serum creatinine < 1.5 times of the upper limit of normal
- Total Bilirubin < 1.5 times upper limit of (institutional) normal (Patients with Gilbert's syndrome total bilirubin must be <4 times institutional upper limit of normal).
- Aspartate Amino Transferase (AST) and Alanine Amino Transferase (ALT) < three times the upper limit of (institutional) normal (ULN) (if related to liver metastases < five times ULN). 5) Eastern Cooperative Oncology Group (ECOG) score between 0 - 2 6) written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law.
Exclusion criteria:
- prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
- use of anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and / or gonadorelin analogues for treatment of prostate cancer permitted)
radiotherapy within 4 weeks prior to drug administration except as follows:
- palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
- single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
- major surgery within 4 weeks from day 1 of first dose of afatinib. At least 7 days should have elapsed since minor surgical procedure including placement of an access device or fine needle aspiration and at least 14 days for diagnostic or palliative video-assisted thoracoscopic surgery (VATS).
- known hypersensitivity to afatinib or any of its excipients
- history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) classification of >3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to starting trial treatment.
- Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use medically acceptable method of contraception during the trial entry and for at least 4 weeks after treatment has ended. Adequate methods of contraception and Women of Child-Bearing Potential. Perimenopausal women must be amenorrhoeic for at least 24 months to be considered for non-childbearing potential.
childbearing potential (see Section 4.2.3) who:
- are nursing or
- are pregnant or
- are not using an acceptable method of birth control, or do not plan to continue using this method throughout the trial and/or do not agree to submit to pregnancy testing required by this protocol
- history of or co-existing condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of safety for the trial drug
- previous or concomitant malignancies at other sites, except effectively treated nonmelanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
- requiring treatment with any of the prohibited concomitant medications listed, that cannot be stopped for the duration of trial participation
- known pre-existing interstitial lung disease
- presence of poorly controlled gastrointestinal disorders that could affect the absorption of the trial drug (e.g. Crohn's disease, ulcerative colitis, malabsorption, or CTC grade =2 diarrhoea of any aetiology) based on investigator assessment.
- Known active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier.
- meningeal carcinomatosis
- symptomatic brain metastases (patients with brain metastases, who were previously treated, are eligible provided they have asymptomatic brain metastasis for at least 4 weeks on stable doses of medication)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Afatinib
Patient will receive afatinib once daily
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Patient will receive afatinib once daily
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Participants With Serious Adverse Events (SAEs)
Tijdsspanne: From first drug administration up to 28 days after last drug administration, up to 1624 days.
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Percentage of participants with serious adverse events (SAEs).
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From first drug administration up to 28 days after last drug administration, up to 1624 days.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Time to Symptomatic Progression (TTSP)
Tijdsspanne: From first drug administration until date of first documented clinically significant symptomatic progression that required stopping afatinib treatment, up to 1624 days.
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Time to Symptomatic progression (TTSP) was defined as time from first administration of afatinib to date of first documented clinically significant symptomatic progression that required stopping the anti-cancer treatment according to investigator's assessment.
95% confidence intervals (CIs) for the median was calculated for TTSP using Greenwood' standard error estimate.
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From first drug administration until date of first documented clinically significant symptomatic progression that required stopping afatinib treatment, up to 1624 days.
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Percentage of Participants With Drug-related (Afatinib-related) Adverse Events
Tijdsspanne: From first drug administration up to 28 days after last drug administration, up to 1624 days.
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Percentage of participants with drug-related (afatinib-related) adverse events.
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From first drug administration up to 28 days after last drug administration, up to 1624 days.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Zhao J, Bai H, Wang X, Wang Y, Duan J, Chen H, Xue Z, Tian Y, Cseh A, Huang DC, Wu YL, Wang J. Biomarker subset analysis of a phase IIIb, open-label study of afatinib in EGFR tyrosine kinase inhibitor-naive patients with EGFRm+ non-small-cell lung cancer. Future Oncol. 2022 Apr;18(12):1485-1497. doi: 10.2217/fon-2021-0394. Epub 2022 Feb 4.
- Tu HY, Feng J, Shi M, Zhao J, Wang Y, Chang J, Wang J, Cheng Y, Zhu J, Tan EH, Li K, Zhang Y, Lee V, Yang CT, Su WC, Lam DC, Srinivasa BJ, Rajappa S, Ho CL, Lam KC, Hu Y, Bondarde SA, Liu X, Tian Y, Xue Z, Cseh A, Huang DC, Zhou C, Wu YL. A Phase IIIb Open-Label, Single-Arm Study of Afatinib in EGFR TKI-Naive Patients with EGFRm+ NSCLC: Final Analysis, with a Focus on Patients Enrolled at Sites in China. Target Oncol. 2022 Jan;17(1):1-13. doi: 10.1007/s11523-021-00859-6. Epub 2022 Jan 12.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
30 september 2013
Primaire voltooiing (Werkelijk)
6 juli 2018
Studie voltooiing (Werkelijk)
6 juli 2018
Studieregistratiedata
Eerst ingediend
25 september 2013
Eerst ingediend dat voldeed aan de QC-criteria
26 september 2013
Eerst geplaatst (Schatting)
1 oktober 2013
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 augustus 2019
Laatste update ingediend die voldeed aan QC-criteria
27 juni 2019
Laatst geverifieerd
1 juni 2019
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Longneoplasmata
- Carcinoom, niet-kleincellige long
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Proteïnekinaseremmers
- Afatinib
Andere studie-ID-nummers
- 1200.66
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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University of Alabama at BirminghamBeëindigdAnaplastisch grootcellig lymfoom | Angioimmunoblastisch T-cellymfoom | Perifere T-cellymfomen | Volwassen T-celleukemie | Volwassen T-cellymfoom | Perifeer T-cellymfoom niet gespecificeerd | T/Null Cell Systemisch Type | Cutaan t-cellymfoom met nodale / viscerale ziekteVerenigde Staten
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Masonic Cancer Center, University of MinnesotaWervingLymfoom | Folliculair lymfoom | Acute myeloïde leukemie | Multipel myeloom | Myelofibrose | Juveniele myelomonocytaire leukemie | Burkitt lymfoom | Acute lymfatische leukemie | Lymfoblastisch lymfoom | Chronische lymfatische leukemie | Lymfoplasmacytisch lymfoom | Acute leukemie | Mantelcellymfoom | Chronische myelogene... en andere voorwaardenVerenigde Staten
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Masonic Cancer Center, University of MinnesotaBeëindigdFolliculair lymfoom | Myelodysplastische syndromen | Multipel myeloom | Hodgkin lymfoom | Burkitt lymfoom | Acute lymfatische leukemie | Chronische lymfatische leukemie | Lymfoplasmacytisch lymfoom | Acute myeloïde leukemie | Mantelcellymfoom | Chronische myelogene leukemie | Prolymfatische Leukemie | Klein lymfocytisch... en andere voorwaardenVerenigde Staten
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Klinische onderzoeken op Afatinib
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Boehringer IngelheimVoltooid
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Boehringer IngelheimVoltooidNeuro-ectodermale tumoren | RhabdomyosarcoomVerenigde Staten, Spanje, Canada, Duitsland, Italië, Verenigd Koninkrijk, Australië, Oostenrijk, Denemarken, Faeröer Eilanden, Frankrijk, Nederland
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Boehringer IngelheimGoedgekeurd voor marketing
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Boehringer IngelheimVoltooid
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Boehringer IngelheimNiet meer beschikbaar
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Boehringer IngelheimVoltooidCarcinoom, niet-kleincellige longKorea, republiek van
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Boehringer IngelheimVoltooid