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

NCT04535557 | Unknown

• 2 other identifiers: Mobocertinib EAPU1111-1257-1911
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Drug Therapy

Interventions

Mobocertinib 160 mg DRUG

Mobocertinib 160 mg, capsule, orally, once daily in 28-day treatment cycles for up to approximately 4 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

mobocertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 2, 2020
• Last Updated: September 30, 2022

Record last verified: 2022-09