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A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression

24 marca 2015 zaktualizowane przez: Hoffmann-La Roche

A Multi-centre, Open-label, Phase IV, Interventional Study to Evaluate the Efficacy of Erlotinib (Tarceva®) Following 4 Cycles of Platinum-based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Not Experienced Disease Progression or Unacceptable Toxicity During Chemotherapy

This open-label, single-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer who have completed 4 cycles of standard platinum-based chemotherapy without progression. Patients will receive Tarceva at a dose of 150 mg orally daily until disease progression or unacceptable toxicity occurs.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

51

Faza

  • Faza 4

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Indie
      • Bangalore, Indie, 560027
      • Chennai, Indie, 600035
      • Delhi, Indie, 110085
      • Hyderabad, Indie, 500 034
      • Jaipur, Indie, 302 017
      • Kolkata, Indie, 700026
      • Nasik, Indie, 422005

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Adult patients ≥ 18 years of age.
  • Histologically documented non-small cell lung cancer (NSCLC).
  • Locally advanced or recurrent (Stage IIIB) or metastatic (Stage IV) disease.
  • Completion of 4 cycles of an acceptable, standard, platinum-based chemotherapy doublet without progression.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • Patients of reproductive potential must agree to use effective contraception.

Exclusion Criteria:

  • Prior exposure to agents directed at the human epidermal growth factor receptor (HER) axis (eg, gefitinib, cetuximab, trastuzumab).
  • Prior treatment with any monoclonal antibody therapy.
  • Any other malignancies within the previous 5 years, except for adequately treated carcinoma in situ of the cervix or squamous cell skin cancer.
  • Clinically significant cardiovascular, hepatic, renal, or metabolic disease or active infection
  • Pre-existing interstitial lung disease.
  • Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
  • Pregnant or lactating women.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Erlotinib
Participants received erlotinib 150 mg orally once a day for 48 weeks.
Lek: Erlotinib
Erlotinib was supplied as tablets.
Inne nazwy:
  • Tarcewa

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percentage of Participants With Progression-free Survival at Week 52
Ramy czasowe: From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).
A participant had progression-free survival if they did not have disease progression and were alive. Tumor assessments were done by magnetic resonance imaging according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.
From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Progression-free Survival (PFS)
Ramy czasowe: From the date of enrolment until the end of the study (up to 2 years, 6 months).
PFS was defined as the time from the date of enrolment to the date of disease progression (PD) or death, whichever occurred first. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions (TL), taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-TLs. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as TLs at Baseline. TLs should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all TLs will be calculated and reported as the Baseline sum longest diameter.
From the date of enrolment until the end of the study (up to 2 years, 6 months).
Overall Survival
Ramy czasowe: From the date of enrolment until the end of the study (up to 2 years, 6 months).
Overall survival was defined as the time from the date of enrolment to the date of death from any cause.
From the date of enrolment until the end of the study (up to 2 years, 6 months).
Percentage of Participants With a Complete Response (CR) or a Partial Response (PR)
Ramy czasowe: From the date of enrolment until the end of the study (up to 2 years, 6 months).
A CR was defined as the disappearance of all target lesions. A PR was defined as at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the Baseline sum longest diameter. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. All other lesions (or sites of disease) should be identified as non-target lesions. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.
From the date of enrolment until the end of the study (up to 2 years, 6 months).
Percentage of Participants With Disease Control
Ramy czasowe: From the date of enrolment until the end of the study (up to 2 years, 6 months).
A participant with disease control was defined as a participant with either a complete response (CR), a partial response (PR), or stable disease (SD), as determined using RECIST v1.1. A CR was defined as the disappearance of all target lesions (TL). A PR was defined as at least a 30% decrease in the sum of the longest diameter of TLs taking as reference the Baseline sum longest diameter (SLD). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the unequivocal progression of existing non-TLs. A SLD for all TLs will be calculated and reported as the Baseline SLD. Tumor assessments were done by magnetic resonance imaging according to RECIST v1.1.
From the date of enrolment until the end of the study (up to 2 years, 6 months).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Hoffmann-La Roche

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 marca 2011

Zakończenie podstawowe (Rzeczywisty)

1 września 2013

Ukończenie studiów (Rzeczywisty)

1 września 2013

Daty rejestracji na studia

Pierwszy przesłany

28 października 2010

Pierwszy przesłany, który spełnia kryteria kontroli jakości

28 października 2010

Pierwszy wysłany (Oszacować)

29 października 2010

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

30 marca 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

24 marca 2015

Ostatnia weryfikacja

1 marca 2015

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ML25478

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