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Erlotinib as Neoadjuvant Treatment in Patients With Stage ⅢA N2 NSCLC With Activating EGFR Mutation. (ML25444)

11. september 2017 opdateret af: Baohui Han

A Single Arm, One Center, Phase Ⅱ Study of Erlotinib as Neoadjuvent Treatment in Patients With Endobronchial Ultrasound Confirmed Stage ⅢA N2 NSCLC With EGFR Mutation in Exon 19 or 21

This is a single arm, one center, phaseⅡ study evaluating efficacy and safety of erlotinib as neoadjuvent treatment in patients with EBUS confirmed stage ⅢA N2 NSCLC with activating EGFR mutation in exon 19 or 21.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Screening phase:

Patients clinically diagnosed as stage ⅢA N2 lung caner by CT technique will be pathologically proven as NSCLC with N2 by EBUS. The pathology specimen will be detected EGFR mutation by DNA sequencing. The patients with EGFR mutation in exon 19 or 21 will be enrolled in this study.

Neoadjuvant treatment phase:

Patient will receive erlotinib 150mg/day. Treatment will be scheduled to continue for a total of 8 weeks or disease progression or unacceptable toxicities.

Surgery treatment phase:

Tumor response will be evaluated with CT scan after 8 weeks of induction treatment. The patients with responsive disease considered to be technique resectable will undergo resection.

Post-surgery phase:

It is the discretion of the investigator whether the patient is a candidate for post-operative treatment which is considered to be in the best interest of the patients. It is recommended that patients with positive margins or residual tumor after surgery should receive radiation therapy. Patients after surgery will receive long-term follow-up including chest CT scan every 3 months for up to 2 years.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

25

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Shanghai
      • Shanghai, Shanghai, Kina, 200030
        • Shanghai Chest Hospital

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

Inclusion Criteria:

Written informed consent provided. Males or females aged ≥18 years. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.

Stage IIIA N2 NSCLC according to the pathological evidence of endobronchial ultrasound(EBUS).

The biopsy specimen shows EGFR mutation in exon 19 or 21 by DNA sequencing. Measurable disease must be characterized according to RECIST criteria: measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥20cm with conventional techniques (PE, CT, XR, MRI) or as ≥ 10cm with spiral scan.

ECOG performance status 0-1. Life expectancy ≥12 weeks.

Female subjects should not be pregnant or breast-feeding.

Exclusion Criteria:

The biopsy specimen shows EGFR wildtype in exon 19 or 21 by DNA sequencing. Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).

Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).

Known hypersensitivity to Tarceva or any of its recipients.

Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the subject at high risk for treatment-related complications.

Sexually active males and females(of childbearing potential) unwilling to practice contraception during the study.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Erlotinib
Single-arm
Medicin: erlotinib
erlotinib 150mg/d continuously for 56 days
Andre navne:
  • Tarceva

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
radical resection rate
Tidsramme: operation after effective neoadjuvant treatment of tarceva for 56 days
To evaluate radical resection rate of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21.
operation after effective neoadjuvant treatment of tarceva for 56 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pathological Complete Remission
Tidsramme: operation after effective neoadjuvant treatment of tarceva for 56 days
To evaluate Pathological Complete Remission (pCR) rate of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21.
operation after effective neoadjuvant treatment of tarceva for 56 days
Objective Response Rate
Tidsramme: Objective Response Rate measured by RECIST criteria in ITT population treated by erlotinib
To evaluate Objective Response Rate (ORR) of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21.
Objective Response Rate measured by RECIST criteria in ITT population treated by erlotinib
disease free survival
Tidsramme: From surgery to disease relapse or death
To evaluate disease free survival(DFS) of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21.
From surgery to disease relapse or death
overall survival
Tidsramme: From study treatment to death due to any cause
To evaluate overall survival(OS) of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21.
From study treatment to death due to any cause
quality of life
Tidsramme: During study treatment period
To evaluate quality of life(QOL) of Tarceva as neoadjuvant treatment in patient with EBUS confirmed stage ⅢA N2 NSCLC with EGFR mutation in exon 19 or 21.
During study treatment period
safety profile
Tidsramme: For all the patient accepted study treatment
To evaluate the safety profile using NCI CTC AE(version 4.0)
For all the patient accepted study treatment
explorative biomarkers
Tidsramme: During study conduction period
To evalutate the relationship between biomarker and Tarceva neoadjuvent treatment efficacy (TBD).
During study conduction period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Baohui Han

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

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 (Faktiske)

2. marts 2011

Primær færdiggørelse (Faktiske)

30. juni 2016

Studieafslutning (Faktiske)

30. oktober 2016

Datoer for studieregistrering

Først indsendt

7. oktober 2010

Først indsendt, der opfyldte QC-kriterier

7. oktober 2010

Først opslået (Skøn)

8. oktober 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. september 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2017

Sidst verificeret

1. september 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ML25444

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 .

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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