A Study of Prexasertib (LY2606368) in Participants With Extensive Stage Disease Small Cell Lung Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Small Cell Lung Cancer

Treatments: Drug: Prexasertib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02735980

16015

2015-005069-21 (EudraCT Number)

I4D-MC-JTJH (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of prexasertib when given to participants with extensive stage disease small cell lung cancer (ED-SCLC). The study will evaluate how the body processes the drug and how the drug affects the body. The study will also evaluate the association between tumor response and the participant's perceived quality of life.

Enrollment: 133 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have ED-SCLC and have received a prior platinum-based regimen
• Participants in Cohort 1 and in the addendum must have had an objective response to prior platinum-based therapy with subsequent progression ≥90 days after the last dose of platinum
• Participants in Cohort 2 must have either not had an objective response to prior platinum based therapy or had progression <90 days after the last dose of platinum
• Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group scale

Exclusion criteria

• Have received more than 2 prior therapies for ED-SCLC (including immunotherapy, targeted therapies, or chemotherapy)
• Have symptomatic central nervous system (CNS) malignancy or metastasis. Asymptomatic participants with treated CNS metastases are eligible for this study if they are not currently receiving corticosteroids to treat CNS metastases
• Have previously completed or withdrawn from this study or any other study investigating prexasertib or a checkpoint kinase I (CHK1) inhibitor or have shown hypersensitivity to any of the components of the prexasertib formulation
• Have a serious cardiac condition

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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133 participants in 3 patient groups

Prexasertib (Platinum Sensitive Disease)

Experimental group

Description:

105 mg/m\^2 Intravenous (IV) prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had platinum-sensitive disease (has prior platinum based therapy with subsequent progression greater or less than 90 days after last dose of platinum based therapy).

Treatment:

Drug: Prexasertib

Prexasertib (Platinum Resistant Disease)

Experimental group

Description:

105 mg/m\^2 IV prexasertib administered of every 14 days with extensive stage disease small cell lung cancer (ED-SCLC) who had resistant/refractory disease (did not have an objective response to platinum-based therapy or had progression greater than 90 days after the last dose of platinum).

Treatment:

Drug: Prexasertib

Prexasertib Exploratory Addendum (Platinum Sensitive Disease)

Experimental group

Description:

40 mg/m\^2 IV prexasertib Day 1, 2, and Day 3 of a 14 day cycle in participants with ED-SCLC platinum sensitive disease.

Treatment:

Drug: Prexasertib