Low recruitment

This a Phase 1 study designed to determine the maximum tolerated dose (MTD) and toxicity of attenuated Measles virus (MV-NIS) combined with Atezolizumab in patients with recurrent and metastatic NSCLC.

Phase 1, dose escalation study of the combination of intra-tumoral MV-NIS and systemic atezolizumab in patients with recurrent and metastatic NSCLC. After the dose escalation phase of the trial, a dose expansion cohort was planned to further investigate safety, clinical and immune responses at the MTD. A standard 3+3 design was to be used for the dose escalation part of the study. Starting at dose level 1, three patients were to be treated per dose level. MV-NIS was to be administered once intra-tumorally (IT) on Day 1 of treatment in 3 escalating dose cohorts, starting at dose level 1 x 10e8

Key Inclusion Criteria:

• Diagnosis of metastatic lung cancer, with histologic confirmation of the primary NSCLC histology and with at least one lesion amenable for intra-tumoral injection of MV-NIS.
• Patient meets the FDA-approved indication for Atezolizumab treatment in NSCLC.
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
• Ability to provide informed consent.
• Adequate hematological, liver and kidney function.
• Must be willing to implement contraception throughout study and for the 8 weeks following last study drug administration.

Key Exclusion Criteria:

• Any of the following prior therapy: Chemotherapy ≤ 3 weeks prior to registration. Biologic therapy ≤ 4 weeks prior to registration. Radiation therapy ≤ 3 weeks prior to registration
• Other concurrent investigational therapy (utilized for a non-FDA-approved indication and in the context of a research investigation).
• Pregnant women.
• Nursing women.
• Men or women of childbearing potential who are unwilling to employ adequate contraception during treatment and 8 weeks following the completion of study drug treatment.
• Allergy to measles vaccine or history of severe reaction to prior measles vaccination.
• History of organ transplantation.

A maximum of 21 patients were planned for this study, 2 patients were treated prior to the closure of the study. The study was closed for administrative reasons.

AE data was collected from when the patient was enrolled in the study starting from the day of informed consent until 30 days after the last dose of study drug or the patient withdraws from the study. Event reporting occurred over a total period of 3 months (23August 2017-09Nov2017), the duration of the study.

Study was closed prematurely due to administrative reasons.