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

September 28, 2022 updated by: Millennium Pharmaceuticals, Inc.

An Expanded Access Protocol for Mobocertinib in Refractory Non-Small Cell Lung Cancer Patients With EGFR exon20 Insertion Mutations

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.

Study Overview

Status

Approved for marketing

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Millennium Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 28, 2020

First Submitted That Met QC Criteria

August 28, 2020

First Posted (Actual)

September 2, 2020

Study Record Updates

Last Update Posted (Actual)

September 30, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mobocertinib EAP
  • U1111-1257-1911 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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