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An Expanded Access Protocol for Mobocertinib in Refractory Non-small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Exon20 Insertion Mutations

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Mobocertinib 160 mg
Sponsored by
Millennium Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Carcinoma, Non-Small-Cell Lung focused on measuring Drug Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  1. Have histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic NSCLC
  2. Have a documented EGFR in-frame exon 20 insertion mutations
  3. . Must have received at least 1 prior line of therapy for locally advanced or metastatic disease
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  5. Normal QT interval on screening electrocardiogram (ECG), defined as QT interval corrected Fridericia (QTcF) of less than or equal to (<=) 450 milliseconds (ms) in males or <=470 ms in females

Exclusion Criteria:

  1. Received small-molecule anticancer therapy (including cytotoxic chemotherapy and investigational agents) <=14 days prior to first dose of mobocertinib (except for reversible EGFR tyrosine kinase inhibitors (TKIs) [that is, erlotinib or gefitinib], which are allowed up to 7 days prior to the first dose of mobocertinib)
  2. Received radiotherapy <=14 days prior to the first dose of mobocertinib or has not recovered from radiotherapy-related toxicities. Palliative radiation administered outside the chest and brain, stereotactic radiosurgery (SRS), and stereotactic body radiotherapy are allowed up to 7 days prior to the first dose
  3. Have known active brain metastases. Brain metastases are allowed if they have been treated with surgery and/or radiation
  4. Have current spinal cord compression or leptomeningeal disease

  5. Have significant, uncontrolled, or active cardiovascular disease, including, but not restricted to:

    • Myocardial infarction (MI);
    • Unstable angina;
    • Congestive heart failure (CHF);
    • Clinically significant arrhythmia;
    • Ventricular arrhythmia; or
    • Cerebrovascular accident;
    • Transient ischemic attack.
    • Cardiac ejection fraction less than (<) 50 percent (%) by echocardiogram or multigated acquisition (MUGA) scan.
  6. Have prolonged QTcF interval, or being treated with medications known to be associated with the development of Torsades de Pointes
  7. Have presence of diarrhea that can be related to anti-tumoral treatment (including EGFR TKI, immune therapy, chemotherapy, and investigational therapies)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 28, 2020
    Last Updated
    September 28, 2022
    Sponsor
    Millennium Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04535557
    Brief Title
    An Expanded Access Protocol for Mobocertinib in Refractory Non-small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Exon20 Insertion Mutations
    Official Title
    An Expanded Access Protocol for Mobocertinib in Refractory Non-Small Cell Lung Cancer Patients With EGFR exon20 Insertion Mutations
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Approved for marketing
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Millennium Pharmaceuticals, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to provide expanded compassionate use access to mobocertinib, in participants with locally advanced or metastatic NSCLC harboring EGFR in-frame exon 20 insertion mutations and who have received at least 1 prior line of therapy for locally advanced or metastatic disease.
    Detailed Description
    The drug being tested in this study is called mobocertinib. Mobocertinib is being tested to treat people who have NSCLC with EGFR exon-20 insertion mutations who have failed the current standard of care (SOC) have no approved treatment therapies. Participants will be treated with mobocertinib until they experience progressive disease (PD) that requires an alternate therapy in the opinion of the physician, intolerable toxicity, or another discontinuation criterion. Treatment may be continued after PD if, in the opinion of the physician, the participant continues to experience clinical benefit. The study will enroll approximately 100 participants. Enrollment will be based on unsolicited participant requests. All participants will be assigned to receive- • Mobocertinib 160 milligram (mg) Dose interruptions or reductions (first dose reduction- 120 mg and second dose reduction- 80 mg) will be implemented for participants who experience treatment-related adverse events (TEAEs), based on the clinical judgment of the investigator. This multi-center trial will be conducted in the United States. The overall time to participate in this expanded access study is 4 months. The follow-up period for survival begins at the end of treatment (up to 30 days past last dose) and continues until participant discontinues.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma, Non-Small-Cell Lung
    Keywords
    Drug Therapy

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Mobocertinib 160 mg
    Intervention Description
    Mobocertinib 160 mg, capsule, orally, once daily in 28-day treatment cycles for up to approximately 4 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Have histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic NSCLC Have a documented EGFR in-frame exon 20 insertion mutations . Must have received at least 1 prior line of therapy for locally advanced or metastatic disease Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2 Normal QT interval on screening electrocardiogram (ECG), defined as QT interval corrected Fridericia (QTcF) of less than or equal to (<=) 450 milliseconds (ms) in males or <=470 ms in females Exclusion Criteria: Received small-molecule anticancer therapy (including cytotoxic chemotherapy and investigational agents) <=14 days prior to first dose of mobocertinib (except for reversible EGFR tyrosine kinase inhibitors (TKIs) [that is, erlotinib or gefitinib], which are allowed up to 7 days prior to the first dose of mobocertinib) Received radiotherapy <=14 days prior to the first dose of mobocertinib or has not recovered from radiotherapy-related toxicities. Palliative radiation administered outside the chest and brain, stereotactic radiosurgery (SRS), and stereotactic body radiotherapy are allowed up to 7 days prior to the first dose Have known active brain metastases. Brain metastases are allowed if they have been treated with surgery and/or radiation Have current spinal cord compression or leptomeningeal disease Have significant, uncontrolled, or active cardiovascular disease, including, but not restricted to: Myocardial infarction (MI); Unstable angina; Congestive heart failure (CHF); Clinically significant arrhythmia; Ventricular arrhythmia; or Cerebrovascular accident; Transient ischemic attack. Cardiac ejection fraction less than (<) 50 percent (%) by echocardiogram or multigated acquisition (MUGA) scan. Have prolonged QTcF interval, or being treated with medications known to be associated with the development of Torsades de Pointes Have presence of diarrhea that can be related to anti-tumoral treatment (including EGFR TKI, immune therapy, chemotherapy, and investigational therapies)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Millennium Pharmaceuticals, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    An Expanded Access Protocol for Mobocertinib in Refractory Non-small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Exon20 Insertion Mutations

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