Clinical Trials /

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

NCT02088112

Description:

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

Related Conditions:
  • Lung Carcinoma
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

MEDI4736 (<span class="go-doc-concept go-doc-intervention">Anti PD-L1</span>) Combined With Gefitinib in Subjects With Non-Small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span>(NSCLC)

Title

  • Brief Title: MEDI4736 (Anti PD-L1) Combined With Gefitinib in Subjects With Non-Small Cell Lung Cancer(NSCLC)
  • Official Title: 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)
  • Clinical Trial IDs

    NCT ID: NCT02088112

    ORG ID: D791PC00001

    Trial Conditions

    Patients With Non-Small Cell Lung Cancer(NSCLC)

    Trial Interventions

    Drug Synonyms Arms
    Gefitinib Escalation, Expansion Arm
    MEDI4736 Escalation, Expansion Arm

    Trial Purpose

    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

    Detailed Description

    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.

    Trial Arms

    Name Type Description Interventions
    Escalation Experimental MEDI4736 will be combined with gefitinib to assess safety and tolerability Gefitinib, MEDI4736
    Expansion Arm Experimental MEDI4736 will be combined with gefitinib Gefitinib, MEDI4736

    Eligibility Criteria

    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, nave 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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    To obtain a preliminary assessment of the anti-tumour activity of gefitinib in combination with MEDI4736 by evaluation of tumour response

    To determine the immunogenicity of MEDI4736 in combination with gefitinib: anti-drug antibodies (ADAs)

    To determine the pharmacokinetics of MEDI4736

    To assess MEDI4736 pharmacodynamics in subjects receiving MEDI4736 in combination with gefitinib.

    Trial Keywords

    NSCLC