Oleclumab (MEDI9447) EGFRm NSCLC Novel Combination Study

• Status: Active, not recruiting
• Trial end date: 2022-05-24
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to investigate the safety, tolerability and antitumor activity of novel combination therapies administered in subjects with advanced EGFRm NSCLC

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedImmune LLC
• Treatments: Osimertinib

Criteria

Inclusion Criteria:

1. Age ≥ 18

2. ECOG Performance Status of 0 or 1

3. Weight ≥ 35 kg

4. Diagnosed with histologically or cytologically confirmed locally advanced/metastatic NSCLC with EGFR mutation

• For Arm A: must have received 1 prior line of therapy with an EGFR TKI and confirmed T790M negative

• For Arm B: must have received at least 2 but not more than 4 prior lines of therapy.

Exclusion Criteria:

1. Receipt of an EGFR TKI within 14 days of the first dose of study treatment.

2. Receipt of any conventional or investigational anticancer therapy not otherwise specified within 21 days of the planned first dose.

3. Prior receipt of any investigational immunotherapy. Subjects may have received agents that have local health authority approval for the disease indication

4. Concurrent enrollment in another therapeutic clinical study. Enrollment in observational studies will be allowed

5. Subjects with a history of venous thrombosis within the past 3 months

6. Subjects with prior history of myocardial infarction, transient ischemic attack, or stroke in the last 6 months

7. Active or prior documented autoimmune or inflammatory disorders within the past 3 years prior to the start of treatment

8. Other invasive malignancy within 2 years.

9. Untreated CNS metastatic disease, leptomeningeal disease, or cord compression

10. Current or prior use of immunosuppressive medication within 14 days prior to the first dose

Additional Exclusion Criteria for Arm A

1. Concurrent treatment (or inability to stop therapy) with medications or herbal supplements known to be potent inducers of CYP3A4

2. Subject has a history of ILD, drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.

3. Subject requires continuous supplemental oxygen for any reason.

Additional Exclusion Criteria for Arm B

1. Herbal preparations/medications are not allowed throughout the study

2. History of seizures excluding those that occurred due to previously untreated CNS metastasis