Clinical trial · Expanded Access
An Expanded Access Protocol for Mobocertinib in Refractory Non-small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Exon20 Insertion Mutations
An Expanded Access Protocol for Mobocertinib in Refractory Non-Small Cell Lung Cancer Patients With EGFR exon20 Insertion Mutations
NCT04535557CI-TRIAL-00061158approved for marketingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mobocertinib 160 mg | Drug | Mobocertinib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.