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Oleclumab (MEDI9447) EGFRm NSCLC Novel Combination Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03381274
Recruitment Status : Active, not recruiting
First Posted : December 21, 2017
Last Update Posted : May 17, 2021
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE December 18, 2017
First Posted Date  ICMJE December 21, 2017
Last Update Posted Date May 17, 2021
Actual Study Start Date  ICMJE May 8, 2018
Estimated Primary Completion Date May 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2017)
  • Incidence of Adverse Events as a measure of safety [ Time Frame: Screening through 90 days after last dose of investigational product ]
    The primary endpoint is safety as assessed by the presence of adverse events and serious adverse events
  • Objective response rate as a measure of anti tumor activity in dose expansion phase [ Time Frame: During treatment through study completion, about 2 years after the last subject dosed ]
    The primary endpoint in dose expansion phase includes efficacy assessed by objective response
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2017)
  • Duration of Response (DoR) [ Time Frame: During treatment through study completion, about 2 years after the last subject dosed ]
    The duration from the first documentation of objective response (OR) to the first documented disease progression or death due to any cause, whichever occurs first
  • Disease Control (DC) [ Time Frame: During treatment through study completion, about 2 years after the last subject dosed ]
    Defined as complete response (CR), partial response (PR) or stable disease (SD)
  • Progression Free Survival (PFS) [ Time Frame: During treatment through study completion, about 2 years after the last subject dosed ]
    From the start of treatment with investigational product until the first documentation of disease progression or death due to any cause, whichever occurs first.
  • Overall Survival (OS) [ Time Frame: During treatment through study completion, about 2 years after the last subject dosed ]
    From the start of treatment with investigational product until death due to any cause
  • Objective Response by T790M status [ Time Frame: During treatment through study completion, about 2 years after the last subject dosed ]
    Defined as best overall response of confirmed CR or confirmed PR according to RECIST version 1.1
  • Disease Control by T790M status [ Time Frame: During treatment through study completion, about 2 years after the last subject dosed ]
    Defined as CR, PR or SD
  • Serum MEDI9447 concentration levels [ Time Frame: During treatment through 90 days after last dose of investigational product ]
    Pharmacokinetic
  • Serum Osimertinib concentration levels [ Time Frame: During treatment through 90 days after last dose of investigational product ]
    Pharmacokinetic
  • Serum AZD4635 concentration levels [ Time Frame: During treatment through 90 days after last dose of investigational product ]
    Pharmacokinetic
  • Development of detectable anti-drug antibody(ADA) to MEDI9447 [ Time Frame: During treatment through 90 days after last dose of investigational product ]
    Immunogenicity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oleclumab (MEDI9447) EGFRm NSCLC Novel Combination Study
Official Title  ICMJE A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects With Previously Treated Advanced EGFRm NSCLC
Brief Summary The objective of this study is to investigate the safety, tolerability and antitumor activity of novel combination therapies administered in subjects with advanced EGFRm NSCLC
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Biological: MEDI9447
    Subjects will receive MEDI9447 in combination with osimertinib or AZD4635 until disease progression
  • Drug: Osimertinib
    Subjects will receive osimertinib in combination with MEDI9447 until disease progression
  • Drug: AZD4635
    Subjects will receive AZD4635 in combination with MEDI9447 until disease progression
Study Arms  ICMJE
  • Experimental: Arm A
    MEDI9447 and osimertinib
    Interventions:
    • Biological: MEDI9447
    • Drug: Osimertinib
  • Experimental: Arm B
    MEDI9447 and AZD4635
    Interventions:
    • Biological: MEDI9447
    • Drug: AZD4635
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 10, 2021)
43
Original Estimated Enrollment  ICMJE
 (submitted: December 18, 2017)
98
Estimated Study Completion Date  ICMJE May 24, 2021
Estimated Primary Completion Date May 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18
  2. ECOG Performance Status of 0 or 1
  3. Weight ≥ 35 kg
  4. Diagnosed with histologically or cytologically confirmed locally advanced/metastatic NSCLC with EGFR mutation

    • For Arm A: must have received 1 prior line of therapy with an EGFR TKI and confirmed T790M negative
    • For Arm B: must have received at least 2 but not more than 4 prior lines of therapy.

Exclusion Criteria:

  1. Receipt of an EGFR TKI within 14 days of the first dose of study treatment.
  2. Receipt of any conventional or investigational anticancer therapy not otherwise specified within 21 days of the planned first dose.
  3. Prior receipt of any investigational immunotherapy. Subjects may have received agents that have local health authority approval for the disease indication
  4. Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed
  5. Subjects with a history of venous thrombosis within the past 3 months
  6. Subjects with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 6 months
  7. Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment
  8. Other invasive malignancy within 2 years.
  9. Untreated CNS metastatic disease, leptomeningeal disease, or cord compression
  10. Current or prior use of immunosuppressive medication within 14 days prior to the first dose

Additional Exclusion Criteria for Arm A

  1. Concurrent treatment (or inability to stop therapy) with medications or herbal supplements known to be potent inducers of CYP3A4
  2. Subject has a history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.
  3. Subject requires continuous supplemental oxygen for any reason.

Additional Exclusion Criteria for Arm B

  1. Herbal preparations/medications are not allowed throughout the study
  2. History of seizures excluding those that occurred due to previously untreated CNS metastasis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 101 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03381274
Other Study ID Numbers  ICMJE D6070C00004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: 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.
Access Criteria: 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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Responsible Party MedImmune LLC
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MedImmune LLC MedImmune LLC
PRS Account MedImmune LLC
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP