Oleclumab (MEDI9447) Epidermal Growth Factor Receptor Mutant (EGFRm) Non-small Cell Lung Cancer (NSCLC) Novel Combination Study
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- NCT03381274
- Lead Sponsor
- MedImmune LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Age = 18<br><br> 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1<br><br> 3. Weight = 35 kg<br><br> 4. Diagnosed with histologically or cytologically confirmed locally advanced/metastatic<br> NSCLC with EGFRm<br><br> - For Arm A (Oleclumab + Osimertinib arms): must have received 1 prior line of<br> therapy with an EGFR tyrosine kinase inhibitor (TKI) and confirmed T790M<br> negative<br><br> - For Arm B (Oleclumab + AZD4635 arms): must have received at least 2 but not<br> more than 4 prior lines of therapy.<br><br>Exclusion Criteria:<br><br> 1. Receipt of an EGFR TKI within 14 days of the first dose of study treatment<br><br> 2. Receipt of any conventional or investigational anticancer therapy not otherwise<br> specified within 21 days of the planned first dose<br><br> 3. Prior receipt of any investigational immunotherapy. Participants may have received<br> agents that have local health authority approval for the disease indication<br><br> 4. Concurrent enrollment in another therapeutic clinical study. Enrollment in<br> observational studies will be allowed.<br><br> 5. Participants with a history of venous thrombosis within the past 3 months<br><br> 6. Participants with prior history of myocardial infarction, transient ischemic attack,<br> or stroke in the last 6 months<br><br> 7. Active or prior documented autoimmune or inflammatory disorders within the past 3<br> years prior to the start of treatment<br><br> 8. Other invasive malignancy within 2 years<br><br> 9. Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease,<br> or cord compression<br><br> 10. Current or prior use of immunosuppressive medication within 14 days prior to the<br> first dose<br><br>Additional Exclusion Criteria for Arm A<br><br> 1. Concurrent treatment (or inability to stop therapy) with medications or herbal<br> supplements known to be potent inducers of cytochrome P (CYP) 3A4<br><br> 2. Participants has a history of interstitial lung disease (ILD), drug-induced ILD,<br> radiation pneumonitis that required steroid treatment, or any evidence of clinically<br> active ILD<br><br> 3. Participants requires continuous supplemental oxygen for any reason<br><br>Additional Exclusion Criteria for Arm B<br><br> 1. Herbal preparations/medications are not allowed throughout the study<br><br> 2. History of seizures excluding those that occurred due to previously untreated CNS<br> metastasis
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Dose-limiting Toxicities (DLTs) in Part 1;Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Parts 1 and 2;Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Parts 1 and 2;Number of Participants With Abnormal Vital Signs and Physical Examination Reported as TEAEs in Parts 1 and 2;Number of Participants With Notable QTc Interval in Parts 1 and 2;Percentage of Participants With Objective Response (OR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in Part 2
- Secondary Outcome Measures
Name Time Method