- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00835471
2nd Line Erlotinib Treatment With (Out) Chemotherapy of Advanced Non Small Cell Lung Cancer (NSCLC) (NVALT10)
A Randomized Phase II Study of Erlotinib Compared to Single Agent Chemotherapy-erlotinib Combination in Pretreated Patients With Advanced NSCLC (NVALT10 Study)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Open randomized multicenter phase II study in patients in need of 2nd line treatment for advanced/metastatic NSCLC. Efficacy and safety of monotherapy with erlotinib will be compared with combination therapy of erlotinib and chemotherapy. In recent studies it was established that pemetrexed activity is more pronounced in non-squamous NSCLC in comparison to squamous cell carcinoma. Therefore in patients with non-squamous carcinoma pemetrexed will be used. As in second line treatment of NSCLC docetaxel is registered also for usage in patients with squamous cell carcinoma, docetaxel will be used in patients with squamous histology.
Chemotherapy will be limited to 4 courses. Erlotinib will be continued until disease progression or unacceptable toxicity.
Erlotinib as monotherapy will be administered continuously. In combination with chemotherapy, erlotinib will be given from day 2-16 of every course of 3 weeks.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Amsterdam, Holland
- VU Medisch Centrum
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Beverwijk, Holland
- Rode Kruis Ziekenhuis
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Breda, Holland
- Amphia Ziekenhuis
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Delft, Holland
- Reinier de Graaf Gasthuis
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Den Bosch, Holland
- Jeroen Bosch Ziekenhuis
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Eindhoven, Holland
- Catharina-ziekenhuis
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Groningen, Holland
- Martini Ziekenhuis
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Haarlem, Holland
- Kennemer Gasthuis
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Maastricht, Holland
- Academisch Ziekenhuis Maastricht
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Nijmegen, Holland
- Universitair Medisch Centrum Sint Radboud
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Rotterdam, Holland
- Maasstad Ziekenhuis
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Rotterdam, Holland
- Sint Franciscus Gasthuis
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The Hague, Holland
- Hagaziekenhuis
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Zwolle, Holland
- Isala Klinieken
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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:
- Histologically or cytologically confirmed NSCLC, locally advanced and metastatic disease stage IIIB and IV. Evidence of disease progression after one or two cytotoxic treatment regimens which should have included a platinum agent.
- Complete recovery from prior chemotherapy side effects to < Grade 2.
- At least one unidimensional measurable lesion meeting RECIST criteria.
- ECOG PS 0-2.
- Age > 18 years.
Adequate organ function, including:
- Adequate bone marrow reserve: ANC > 1.5 x 109/L, platelets > 100 x 109/L.
- Hepatic: bilirubin <1.5 x ULN, AP, ALT, AST < 1.5 x ULN AP, ALT, and AST <5 x ULN is acceptable if the liver has tumor involvement
- Renal: calculated creatinin clearance > 40 ml/min based on the Cockcroft-Gault formula.
- Estimated life expectancy >12 weeks.
- Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate. Female patients with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
- Signed informed consent.
- Patient compliance and geographical proximity that allow adequate follow up.
Exclusion Criteria:
- Pregnant or lactating women.
- Patients with medical risks because of non-malignant disease as well as those with active uncontrolled infection.
- Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrollment.
- Previous treatment with an EGFR-TKI, or in non-squamous histology earlier treatment with pemetrexed and in squamous earlier treatment with docetaxel.
- Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period (5 day period for long-acting agents such as piroxicam).
- Inability or unwillingness to take folic acid, vitamin B-12 supplementation or dexamethasone.
- Concomitant treatment with any other experimental drug under investigation.
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 |
---|---|
Eksperimentel: 1
Erlotinib plus docetaxel (squamous cell NSCLC) or pemetrexed (non-squamous cell NSCLC)
|
non-squamous carcinoma: pemetrexed 500 mg/m2 on Day 1 plus erlotinib 150 mg/day days 2-16, every 21 days. Pemetrexed will be given for a maximum of 4 cycles. Thereafter erlotinib will be continued continuously until disease progression. squamous carcinoma: Docetaxel 75mg/m2 on Day 1 plus erlotinib 150mg/day days 2-16, every 21 days. Docetaxel will be given for a maximum of 4 cycles. Thereafter erlotinib will be continued continuously until disease progression.
Andre navne:
|
Aktiv komparator: 2
Erlotinib
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erlotinib 150 mg/day continuously until disease progression
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Progression Free Survival (PFS)
Tidsramme: From randomisation to date of first progression or date of death, assessed up to 36 months
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to compare the PFS in the group receiving erlotinib alone versus the patients receiving erlotinib + single agent Progression free survival
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From randomisation to date of first progression or date of death, assessed up to 36 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Adverse Events
Tidsramme: From randomisation to 30 days after EoT all AEs are collected
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to compare relevant toxicity (CTC AE vs 3.0) in the group receiving erlotinib alone versus the patients receiving erlotinib + single agent
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From randomisation to 30 days after EoT all AEs are collected
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Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Joachim G. Aerts, MD PhD, Amphia Ziekenhuis, Breda, The Netherlands
- Studieleder: Henk E. Coderington, MD, HagaZiekenhuis, the Hague, The Netherlands
Publikationer og nyttige links
Generelle publikationer
- De Ruysscher D, Dingemans AC, Praag J, Belderbos J, Tissing-Tan C, Herder J, Haitjema T, Ubbels F, Lagerwaard F, El Sharouni SY, Stigt JA, Smit E, van Tinteren H, van der Noort V, Groen HJM. Prophylactic Cranial Irradiation Versus Observation in Radically Treated Stage III Non-Small-Cell Lung Cancer: A Randomized Phase III NVALT-11/DLCRG-02 Study. J Clin Oncol. 2018 Aug 10;36(23):2366-2377. doi: 10.1200/JCO.2017.77.5817. Epub 2018 May 22.
- Witlox WJA, Ramaekers BLT, Groen HJM, Dingemans AM, Praag J, Belderbos J, van der Noort V, van Tinteren H, Joore MA, De Ruysscher DKM. Factors determining the effect of prophylactic cranial irradiation (PCI) in patients with stage-III nonsmall cell lung cancer: exploratory subgroup analyses of the NVALT-11/DLCRG-02 phase-III study. Acta Oncol. 2019 Oct;58(10):1528-1531. doi: 10.1080/0284186X.2019.1629016. Epub 2019 Jul 1. No abstract available.
- Witlox WJA, Ramaekers BLT, Joore MA, Dingemans AC, Praag J, Belderbos J, Tissing-Tan C, Herder G, Haitjema T, Ubbels JF, Lagerwaard J, El Sharouni SY, Stigt JA, Smit EF, van Tinteren H, van der Noort V, Groen HJM, De Ruysscher DKM. Health-related quality of life after prophylactic cranial irradiation for stage III non-small cell lung cancer patients: Results from the NVALT-11/DLCRG-02 phase III study. Radiother Oncol. 2020 Mar;144:65-71. doi: 10.1016/j.radonc.2019.10.016. Epub 2019 Nov 14.
- Aerts JG, Codrington H, Lankheet NA, Burgers S, Biesma B, Dingemans AM, Vincent AD, Dalesio O, Groen HJ, Smit EF; NVALT Study Group. A randomized phase II study comparing erlotinib versus erlotinib with alternating chemotherapy in relapsed non-small-cell lung cancer patients: the NVALT-10 study. Ann Oncol. 2013 Nov;24(11):2860-5. doi: 10.1093/annonc/mdt341. Epub 2013 Aug 28.
Hjælpsomme links
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 (Faktiske)
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
- Molekylære mekanismer for farmakologisk virkning
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Proteinkinasehæmmere
- Folinsyreantagonister
- Docetaxel
- Erlotinib hydrochlorid
- Pemetrexed
Andre undersøgelses-id-numre
- NVALT10
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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