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MEDI4736 (Anti PD-L1) Combined With Gefitinib in Subjects With Non-Small Cell Lung Cancer(NSCLC).

22 mars 2022 uppdaterad av: MedImmune LLC

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Gefitinib in Combination With MEDI4736 (Anti PD-L1) in Subjects With Non-Small Cell Lung Cancer(NSCLC)

This a Phase I, Open-Label, Multicentre Study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of gefitinib in combination with MEDI4736 (anti PD-L1) in Subjects with Non-small cell lung cancer (NSCLC). The study consists of two phases: Escalation phase and an expansion phase to be conducted in locally advanced or metastatic NSCLC subjects

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

In Escalation phase: MEDI4736 and gefitinib in NSCLC subjects In Expansion phase: Subjects with EGFR mutation positive locally advanced or metastatic NSCLC will be enrolled in expansion arms. Initiation of expansion arms with the recommended dose of MEDI4736 in combination with gefitinib will be based on an adequate safety and tolerability profile of the combination from the escalation phase.

Studietyp

Interventionell

Inskrivning (Faktisk)

56

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Florida
      • Tampa, Florida, Förenta staterna, 33612
        • Research Site
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • Research Site
    • Washington
      • Seattle, Washington, Förenta staterna, 98109
        • Research Site
  • Japan
      • Chuo-ku, Japan, 104-0045
        • Research Site
      • Matsuyama-shi, Japan, 791-0280
        • Research Site
  • Korea, Republiken av
      • Seoul, Korea, Republiken av, 05505
        • Research Site
      • Seoul, Korea, Republiken av, 03080
        • Research Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 130 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Key Inclusion Criteria:

  1. Provision of signed and dated, written informed consent
  2. Male or female aged 18 years and older.
  3. Subjects must have a. In the escalation phase, locally advanced or metastatic NSCLC subjects who have either failed to respond or relapsed following any line of standard treatment, were unable to tolerate, or were not eligible for standard treatment b. In the expansion phase, histologically or cytologically confirmed locally advanced or metastatic NSCLC that is EGFR mutation positive, naïve to EGFR TKI therapy, and sensitive to EGFR TKIs therapy
  4. a.For Escalation Phase: At least one lesion (measurable and/or non-measurable) b.For Expansion Phase: At least one measurable lesion.

  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

    • For Japan Escalation - the same as the global escalation I/E criteria except patients must be EGFR mutation positive

Key Exclusion Criteria:

  1. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
  2. Any investigational agent, chemotherapy, immunotherapy, biologic, hormonal within 28 days of the first dose of study treatment
  3. Inadequate bone marrow reserve or organ function

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Escalation
MEDI4736 will be combined with gefitinib to assess safety and tolerability
Läkemedel: Gefitinib
Gefitinib QD
Läkemedel: MEDI4736
MEDI4736 IV Q2W
Experimentell: Expansion Arm
MEDI4736 will be combined with gefitinib
Läkemedel: Gefitinib
Gefitinib QD
Läkemedel: MEDI4736
MEDI4736 IV Q2W

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Escalation Phase: safety and tolerability: AEs, laboratory data, vital signs, ECG changes and Echo. Expansion Phase: safety and tolerability of the recommended dose for MEDI4736; AEs, laboratory data, vital signs, ECG changes and Echo.
Tidsram: From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
AEs: Type, incidence, severity, seriousness and relationship to study medications of adverse events (AE) (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]; Safety Labs: Blood and urine samples for determination of clinical chemistry, hematology, coagulation, thyroid function tests and urinalysis will be taken at the visits; any laboratory abnormalities, and including dose-limiting toxicities (DLTs), ECG measurements and Creatinine Clearance
From first dose of study treatment until 90 days after the last dose, assessed up to 32 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To obtain a preliminary assessment of the anti-tumour activity of gefitinib in combination with MEDI4736 by evaluation of tumour response
Tidsram: From baseline assessment to disease progression, assessed up to 30 months
At each visit subjects will be programmatically assigned a RECIST visit response of CR, PR, SD or PD depending on the status of their disease compared to baseline and previous assessments; Objective response rate: the percentage of subjects who have at least one visit response of CR or PR prior to any evidence of progression . Disease control rate: the percentage of subjects who have at least one visit response of CR or PR or SD prior to any evidence of progression. Progression Free Survival (PFS) : the time from start of study treatment to the first documentation of objective disease progression (PD) or death from any cause.
From baseline assessment to disease progression, assessed up to 30 months
To determine the immunogenicity of MEDI4736 in combination with gefitinib: anti-drug antibodies (ADAs)
Tidsram: From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
Assessed by evaluating the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs). The impact of ADAs on overall MEDI4736 PK will also be evaluated.
From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
To determine the pharmacokinetics of MEDI4736
Tidsram: From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
Individual MEDI4736 concentrations will be tabulated by dose cohort along with descriptive statistics. Noncompartmental PK data analysis will be performed
From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
To assess MEDI4736 pharmacodynamics in subjects receiving MEDI4736 in combination with gefitinib.
Tidsram: From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
PD-L1 levels before and after treatment with MEDI4736 will be measured to evaluate its association with response to treatment with MEDI4736 and clinical outcome
From first dose of study treatment until 90 days after the last dose, assessed up to 32 months
To determine overall survival (OS) in expansion Arm 1 and Arm 1a patients
Tidsram: From final safety follow-up visit after last dose until 1 year after the final patient discontinues investigational product (initial Medi4736).
Survival information may be obtained via telephone contact with the patient, patients family or by checking the patients notes, hospital records, contacting the patients general practitioner or public death registry, where it is possible to do so under applicable local laws.
From final safety follow-up visit after last dose until 1 year after the final patient discontinues investigational product (initial Medi4736).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

MedImmune LLC

Samarbetspartners

AstraZeneca

Utredare

  • Huvudutredare: Sang-We Kim, MD, Asan Medical Center
  • Huvudutredare: Laura Chow, MD, University of Washington
  • Huvudutredare: Ben Creelan, MD, Moffit Cancer Center
  • Huvudutredare: Don Gibbons, MD, M.D. Anderson Cancer Center
  • Huvudutredare: Shinitaro Kanda, MD, National Cancer Center
  • Huvudutredare: Naoyuki Nogami, Shikoku Cancer Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 mars 2014

Primärt slutförande (Faktisk)

9 mars 2021

Avslutad studie (Faktisk)

9 mars 2021

Studieregistreringsdatum

Först inskickad

7 mars 2014

Först inskickad som uppfyllde QC-kriterierna

12 mars 2014

Första postat (Uppskatta)

14 mars 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 april 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 mars 2022

Senast verifierad

1 mars 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • D791PC00001

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Tidsram för IPD-delning

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Kriterier för IPD Sharing Access

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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