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

22 mars 2022 mis à jour par: 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

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

56

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Corée, République de
      • Seoul, Corée, République de, 05505
        • Research Site
      • Seoul, Corée, République de, 03080
        • Research Site
  • Japon
      • Chuo-ku, Japon, 104-0045
        • Research Site
      • Matsuyama-shi, Japon, 791-0280
        • Research Site
  • États-Unis
    • Florida
      • Tampa, Florida, États-Unis, 33612
        • Research Site
    • Texas
      • Houston, Texas, États-Unis, 77030
        • Research Site
    • Washington
      • Seattle, Washington, États-Unis, 98109
        • Research Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 130 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Escalation
MEDI4736 will be combined with gefitinib to assess safety and tolerability
Médicament: Gefitinib
Gefitinib QD
Médicament: MEDI4736
MEDI4736 IV Q2W
Expérimental: Expansion Arm
MEDI4736 will be combined with gefitinib
Médicament: Gefitinib
Gefitinib QD
Médicament: MEDI4736
MEDI4736 IV Q2W

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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.
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
To obtain a preliminary assessment of the anti-tumour activity of gefitinib in combination with MEDI4736 by evaluation of tumour response
Délai: 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)
Délai: 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
Délai: 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.
Délai: 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
Délai: 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).

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

MedImmune LLC

Collaborateurs

AstraZeneca

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

24 mars 2014

Achèvement primaire (Réel)

9 mars 2021

Achèvement de l'étude (Réel)

9 mars 2021

Dates d'inscription aux études

Première soumission

7 mars 2014

Première soumission répondant aux critères de contrôle qualité

12 mars 2014

Première publication (Estimation)

14 mars 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 avril 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 mars 2022

Dernière vérification

1 mars 2022

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • D791PC00001

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

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.

Critères d'accès au partage IPD

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.

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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