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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 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

10

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • Coffs Harbour, New South Wales, Australia, 2450
        • North Coast Cancer Institute
      • Concord, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • Townsville Hospital
      • Southport, Queensland, Australia, 4215
        • ICON Cancer Care
      • Wolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Bedford Park, South Australia, Australia, 5043
        • Flinders Medical Centre
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Eastern Health
      • Frankston, Victoria, Australia, 3199
        • Frankston Hospital
      • Wendouree, Victoria, Australia, 3355
        • Ballarat Oncology and Haematology
  • Forente stater
    • California
      • Fresno, California, Forente stater, 93701
        • Ucsf Fresno
      • Redondo Beach, California, Forente stater, 90277
        • Torrance Memorial Medical Center
    • Florida
      • Boca Raton, Florida, Forente stater, 33486
        • Boca Raton Regional Hospital Lynn Cancer Institute
      • Deerfield Beach, Florida, Forente stater, 33442
        • University of Miami Sylvester Comprehensive Cancer Center Deerfield Beach
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96819
        • Kaiser Permanente Hawaii
    • Louisiana
      • Lafayette, Louisiana, Forente stater, 70503
        • Cancer Center of Acadiana
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
        • Mayo Clinic
    • New Jersey
      • Paramus, New Jersey, Forente stater, 07652
        • Valley Medical Group
    • New York
      • Jamaica, New York, Forente stater, 11432
        • Queens Hospital Cancer Center
    • Ohio
      • Canton, Ohio, Forente stater, 44718
        • Gabrail Cancer Center
      • Canton, Ohio, Forente stater, 44710
        • Aultman Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forente stater, 15232
        • UPMC Cancer Center Cancer
    • Utah
      • Salt Lake City, Utah, Forente 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
  • Italia
      • Benevento, Italia, 82100
        • AO G.Rummo
      • Bologna, Italia, 40138
        • Policlinico S.Orsola Malpighi
      • Cremona, Italia, 26100
        • Istituti Ospitalieri di Cremona - Oncologia
      • Lucca, Italia, 55100
        • U.O.C. Oncologia
      • Milano, Italia, 20132
        • IRCCS Ospedale S.Raffaele
      • Pavia, Italia, 27100
        • Fondazione Salvatore Maugeri
      • Rozzano MI, Italia, 20089
        • IRCCS Istituto Clinico Humanitas
      • Treviglio BG, Italia, 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Erlotinib
Andre navn:
  • Erlotinib hydroklorid
Legemiddel: Ficlatuzumab
Andre navn:
  • 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.
Legemiddel: placebo
Legemiddel: Erlotinib
Andre navn:
  • Erlotinib hydroklorid

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AVEO Pharmaceuticals, Inc.

Samarbeidspartnere

Biodesix, Inc.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. november 2014

Primær fullføring (Faktiske)

1. januar 2017

Studiet fullført (Faktiske)

1. januar 2017

Datoer for studieregistrering

Først innsendt

9. desember 2014

Først innsendt som oppfylte QC-kriteriene

12. desember 2014

Først lagt ut (Anslag)

17. desember 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AV-299-14-206

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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