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


Approved for marketing
Carcinoma, Non-Small-Cell Lung

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

Eligibility Criteria

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 (

Eligibility Gender
Eligibility Age
Minimum: 18 Years

Medical Director
Study Director
Millennium Pharmaceuticals, Inc.

Millennium Pharmaceuticals, Inc.
NCT Number
Drug Therapy
MeSH Terms
Carcinoma, Non-Small-Cell Lung