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Neoadjuvant Afatinib in Early Stage Non Small Cell Lung Cancer. (REMNANT)

21. januar 2016 opdateret af: European Organisation for Research and Treatment of Cancer - EORTC

Resectable EGFR Mutant NSCLC With (or Without) Afatinib as Neoadjuvant Treatment; REMNANT an Exploratory Study of the EORTC Lung Cancer Group

This is a multicenter, randomized, 1:1, non-comparative phase II trial. Patients with early stage NSCLC will be randomized between ARM A: neoadjuvant afatinib followed by surgery and ARM B: immediate surgery with curative intent.

Studieoversigt

Status

Suspenderet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a multicenter, prospective, open-label, randomized, non-comparative, two-arm phase II trial aiming to evaluate afatinib treatment in pre-operative setting in patients with EGFR mutated NSCLC.

After signing of the informed consent, patients will be registered and screened for eligibility and upon confirmation of all eligibility criteria, patients will be randomized 1:1 to:

  • Arm A: once daily afatinib at a dose of 40 mg for 8 weeks followed by surgery with curative intent (anatomical resection and systematic lymph node dissection).
  • Arm B: immediate surgery with curative intent (anatomical resection and systematic lymph node dissection).

Response evaluation in the pre-operative arm will be performed through CT scans at baseline, 4 and 8 weeks.

The first 5 patients enrolled in arm A will be part of a safety run-in to check that afatinib treatment doesn't delay surgery.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

38

Fase

  • Fase 2

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 til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Histological or cytological diagnosis of NSCLC;

  • Patients considered operable and with resectable tumor with curative intent (anatomical resection and systematic lymph node dissection) based on evaluation by a thoracic multi-disciplinary team composed of at least a thoracic surgeon, oncologist and radiologist;
  • Stage I-III (T1a-3, N0-1, M0 according to UICC version 7) NSCLC by local staging criteria potentially treatable by radical (curative) surgery. Patients with T1 tumor at baseline will be limited to 20%;
  • Radiologically measurable disease according to RECIST criteria 1.1; assessed by chest and upper abdomen CT scan within 2 weeks (+1 week) prior to registration); brain CT scan or MRI according to local practice;
  • No prior treatment for NSCLC is allowed;
  • Adequate tissue in terms of quality and quantity for EGFR local testing.

Exclusion Criteria:

  • no adequate bone marrow function within 2 weeks prior to randomization
  • no adequate liver function. Patients with Gilbert's syndrome total bilirubin must be below 4 times institutional upper limit of normal; within 2 weeks prior to randomization
  • no adequate renal function within 2 weeks prior to randomization
  • known positivity to human immunodeficiency virus (HIV), hepatitis B or hepatitis C;
  • known history of allergic reactions attributed to compounds of similar chemical or biological composition;
  • history of a hematologic or primary solid tumor malignancy, unless no evidence of that disease for 5 years, except pT1-2 prostatic cancer Gleason score < 6, superficial bladder cancer, non melanoma skin cancer or carcinoma in situ of the cervix;

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Neo adjuvant afatinib
once daily afatinib at a dose of 40 mg for 8 weeks followed by surgery with curative intent (anatomical resection and systematic lymph node dissection).
Medicin: Afatinib
once daily afatinib at a dose of 40 mg for 8 weeks
Procedure: Immediate surgery
anatomical resection and systematic lymph node dissection
Aktiv komparator: Immediate surgery
immediate surgery with curative intent (anatomical resection and systematic lymph node dissection).
Procedure: Immediate surgery
anatomical resection and systematic lymph node dissection

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Decrease in cT-stage
Tidsramme: 8 weeks
decrease in cT-stage descriptor measured according to RECIST 1.1
8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Response Rate
Tidsramme: 8 weeks
proportion of patients whose response is either complete response (CR) or partial response (PR) using RECIST 1.1;
8 weeks
Change in surgical treatment intent and technique
Tidsramme: 8 weeks
8 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Efterforskere

  • Ledende efterforsker: Sanjay Popat, PhD, Royal Marsden NHS Foundation Trust

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

1. januar 2016

Primær færdiggørelse (Forventet)

1. september 2018

Studieafslutning (Forventet)

1. januar 2021

Datoer for studieregistrering

Først indsendt

10. juni 2015

Først indsendt, der opfyldte QC-kriterier

11. juni 2015

Først opslået (Skøn)

12. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EORTC-08115

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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