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A Phase 2, Study of Ficlatuzumab Plus Erlotinib vs. Placebo Plus Erlotinib in Subjects With Previously Untreated Metastatic, EGFR-mutated NSCLC and BDX004 Positive Label (FOCAL)

20. oktober 2020 opdateret af: AVEO Pharmaceuticals, Inc.

A Phase 2, Multicenter, Randomized, Double-blind Study of Ficlatuzumab Plus Erlotinib Versus Placebo Plus Erlotinib in Subjects Who Have Previously Untreated Metastatic, EGFR-mutated Non-small Cell Lung Cancer (NSCLC) and BDX004 Positive Label

Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a Phase 2 multicenter, controlled, randomized, double-blind study to evaluate the efficacy and safety of ficlatuzumab versus placebo when administered with erlotinib in subjects with previously untreated metastatic EGFR-mutated NSCLC and BDX004 Positive Label.

Prior to screening, subjects will have tested positive for a sensitizing EGFR mutation to determine eligibility for treatment with erlotinib. During screening, subject serum samples will be tested using the investigational companion diagnostic (BDX004) test. Only those subjects who have a BDX004 Positive Label will be enrolled. Subject randomization will be stratified by EGFR mutation type and smoking status (ever versus never smokers). Subjects will be designated as never smokers if they have smoked less than 100 cigarettes in their lifetime. Radiographic tumor assessment, to include CT or MRI of chest and abdomen, will be performed every 4 weeks for the first 8 cycles, and every 8 weeks thereafter, using the same imaging modality per subject. Safety assessments will be performed on an ongoing basis.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Australien
    • New South Wales
      • Camperdown, New South Wales, Australien, 2050
        • Chris O'Brien Lifehouse
      • Coffs Harbour, New South Wales, Australien, 2450
        • North Coast Cancer Institute
      • Concord, New South Wales, Australien, 2139
        • Concord Repatriation General Hospital
    • Queensland
      • Douglas, Queensland, Australien, 4814
        • Townsville Hospital
      • Southport, Queensland, Australien, 4215
        • ICON Cancer Care
      • Wolloongabba, Queensland, Australien, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Bedford Park, South Australia, Australien, 5043
        • Flinders Medical Centre
    • Victoria
      • Box Hill, Victoria, Australien, 3128
        • Eastern Health
      • Frankston, Victoria, Australien, 3199
        • Frankston Hospital
      • Wendouree, Victoria, Australien, 3355
        • Ballarat Oncology and Haematology
  • Forenede Stater
    • California
      • Fresno, California, Forenede Stater, 93701
        • Ucsf Fresno
      • Redondo Beach, California, Forenede Stater, 90277
        • Torrance Memorial Medical Center
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33486
        • Boca Raton Regional Hospital Lynn Cancer Institute
      • Deerfield Beach, Florida, Forenede Stater, 33442
        • University of Miami Sylvester Comprehensive Cancer Center Deerfield Beach
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96819
        • Kaiser Permanente Hawaii
    • Louisiana
      • Lafayette, Louisiana, Forenede Stater, 70503
        • Cancer Center of Acadiana
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic
    • New Jersey
      • Paramus, New Jersey, Forenede Stater, 07652
        • Valley Medical Group
    • New York
      • Jamaica, New York, Forenede Stater, 11432
        • Queens Hospital Cancer Center
    • Ohio
      • Canton, Ohio, Forenede Stater, 44718
        • Gabrail Cancer Center
      • Canton, Ohio, Forenede Stater, 44710
        • Aultman Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • UPMC Cancer Center Cancer
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute
  • Hong Kong
      • Pok Fu Lam, Hong Kong
        • Queen Mary Hospital
    • N.T
      • Tuen Mun, N.T, Hong Kong
        • Tuen Mun Hospital
  • Italien
      • Benevento, Italien, 82100
        • AO G.Rummo
      • Bologna, Italien, 40138
        • Policlinico S.Orsola Malpighi
      • Cremona, Italien, 26100
        • Istituti Ospitalieri di Cremona - Oncologia
      • Lucca, Italien, 55100
        • U.O.C. Oncologia
      • Milano, Italien, 20132
        • IRCCS Ospedale S.Raffaele
      • Pavia, Italien, 27100
        • Fondazione Salvatore Maugeri
      • Rozzano MI, Italien, 20089
        • IRCCS Istituto Clinico Humanitas
      • Treviglio BG, Italien, 24047
        • Ospedale Treviglio-Caravaggio
  • Korea, Republikken
      • Chungcheongbuk-do, Korea, Republikken, 362-711
        • Chungbuk National University Hospital
      • Jeonnam, Korea, Republikken, 519-763
        • Chonnam National University Hwasun Hospital
      • Seoul, Korea, Republikken, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republikken, 120-752
        • Severance Hospital, Yonsei Uni
    • Seoul
      • Guro-gu, Seoul, Korea, Republikken, 152703
        • Korea University Guro Hospital
  • Singapore
      • Central Singapore, Singapore, 308433
        • John Hopkins Singapore International Medical Center
      • Singapore, Singapore, 169610
        • National Cancer Centre
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan, 40201
        • Chung Shan Medical University
      • Tainan, Taiwan, 70403
        • National Cheng Kung University
      • Taipei, Taiwan, 11696
        • Taipei Medical University
      • Taipei City, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei City, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taoyuan City, Taiwan, 333
        • Chang Gung Medical Foundation

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

  • Histologically and/or cytologically confirmed primary diagnosis of Stage IV NSCLC (according to American Joint Committee on Cancer [AJCC] 7th edition lung cancer staging criteria).
  • Measurable disease according to RECIST v.1.1.
  • An EGFR exon 19 deletion and/or an exon 21 (L858R) substitution mutation.
  • BDX004 Positive Label.
  • Have received no prior systemic chemotherapy, immunotherapy, targeted therapy, or biologic therapy for metastatic NSCLC. Subjects may have previously been treated with postoperative adjuvant chemotherapy for early stage lung cancer or chemo radiotherapy for locally advanced disease provided this was completed at least 6 months prior to enrollment. No prior EGFR TKI therapy is allowed for any stage of NSCLC.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria
  • History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational agent or erlotinib.
  • History of known brain metastases.
  • Prior treatment with any other investigational drug or biologic agent within 5 half lives prior to randomization, or any investigational device within 2 weeks prior to randomization.
  • Any unresolved toxicity from previous radiation therapy.

  • Significant cardiovascular disease, including:

    • Echocardiogram (ECHO) or multiple gated acquisition (MUGA) showing left ventricular ejection fraction of less than 55%.
    • Cardiac failure New York Heart Association class III or IV.
    • Myocardial infarction, severe or unstable angina within 6 months prior to randomization.
    • History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation).
    • Significant thrombotic or embolic events within 3 months prior to randomization (significant thrombotic or embolic events include but are not limited to stroke or transient ischemic attack).
    • Any uncontrolled or severe cardiovascular disease.
  • History of prior malignancy within 3 years prior to randomization (except for adequately treated non-melanoma skin cancer, carcinoma in situ of the breast or cervix, superficial bladder cancer, or early stage prostate cancer, without evidence of recurrence).
  • Radiographic evidence of interstitial lung disease.

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ficlatuzumab plus erlotinib
150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with 20 mg/kg Ficlatuzumab administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
Medicin: Erlotinib
Andre navne:
  • Erlotinib hydrochlorid
Medicin: Ficlatuzumab
Andre navne:
  • Ficla
Aktiv komparator: Placebo plus erlotinib
150 mg Erlotinib orally once daily starting on Day 1 of Cycle 1 with Placebo administered intravenously once every 2 weeks on Day 1 and Day 15 of each 28 day cycle.
Medicin: placebo
Medicin: Erlotinib
Andre navne:
  • Erlotinib hydrochlorid

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression Free Survival (PFS)
Tidsramme: Approximately 24 months
Progression Free Survival is defined as the time from the date of randomization to the date of the first objective documentation of radiographic disease progression or death due to any cause, whichever occurs first.
Approximately 24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Adverse Events
Tidsramme: Approximately 24 months
To evaluate Safety and tolerability of ficlatuzumab plus erlotinib versus placebo plus erlotinib in subjects who have previously untreated metastatic EGFR-mutated NSCLC and a BDX004 Positive Label.
Approximately 24 months

Samarbejdspartnere og efterforskere

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

Sponsor

AVEO Pharmaceuticals, Inc.

Samarbejdspartnere

Biodesix, Inc.

Efterforskere

  • Studieleder: Michael N Needle, MD, AVEO Pharmaceuticals, Inc.

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)

1. november 2014

Primær færdiggørelse (Faktiske)

1. januar 2017

Studieafslutning (Faktiske)

1. januar 2017

Datoer for studieregistrering

Først indsendt

9. december 2014

Først indsendt, der opfyldte QC-kriterier

12. december 2014

Først opslået (Skøn)

17. december 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AV-299-14-206

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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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