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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|ClinicalTrials.gov Identifier: NCT04535557|
Expanded Access Status : Available
First Posted : September 2, 2020
Last Update Posted : September 2, 2020
|Condition or disease||Intervention/treatment|
|Carcinoma, Non-Small-Cell Lung||Drug: Mobocertinib 160 mg|
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|
|Official Title:||An Expanded Access Protocol for Mobocertinib in Refractory Non-Small Cell Lung Cancer Patients With EGFR exon20 Insertion Mutations|
- Drug: Mobocertinib 160 mg
Mobocertinib 160 mg, capsule, orally, once daily in 28-day treatment cycles for up to approximately 4 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04535557
|Contact: Takeda Study Registration Call Centeremail@example.com|
|Study Director:||Medical Director||Millennium Pharmaceuticals, Inc.|