LB-100, Carboplatin, Etoposide, and Atezolizumab for the Treatment of Untreated Extensive-Stage Small Cell Lung Cancer

Description

PRIMARY OBJECTIVE:

I. To determine the recommended phase II dose (RP2D) of protein phosphatase 2A inhibitor LB-100 (LB-100) when given in combination with standard carboplatin/etoposide/atezolizumab in treatment naive patients with extensive-stage small cell lung cancer (ED-SCLC).

SECONDARY OBJECTIVES:

I. To assess objective response rate (ORR). II. To assess progression-free survival (PFS). III. To assess overall survival (OS). IV. To assess duration of overall response (DOR). V. To assess safety and adverse events (AEs).

EXPLORATORY OBJECTIVES:

I. The pharmacokinetics (PK) of LB-100 and etoposide. II. The biomarkers relevant to LB-100 and the disease state as well as their correlation to clinical outcomes.

OUTLINE: This is a dose-escalation study of LB-100.

INDUCTION: Patients receive LB-100 intravenously (IV) over 15 minutes on days 1 and 3, atezolizumab IV over 30-60 minutes on day 1, carboplatin IV over 30-60 minutes on day 1, and etoposide IV over 60 minutes on days 1-3. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: After completion of induction therapy, patients receive LB-100 IV over 15 minutes on days 1 and 3 and atezolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for up to 30 days, and patients who discontinue study treatment without disease progression are followed every 6-8 weeks thereafter.