Phase 2 Study of Onvansertib for Relapsed Small Cell Lung Cancer

This study is testing a drug called onvansertib for people with small cell lung cancer (SCLC) that has come back or didn't respond to chemotherapy. Onvansertib works by blocking an enzyme (a type of protein) called PLK-1, which is often found in high levels in cancer cells. The study aims to see how well onvansertib shrinks tumors (Objective Response Rate) over a period of up to 42 months. You might be able to join if you are 18 or older, have SCLC that can be measured, and have received no more than two previous treatments. The study plans to enroll 37 participants, but the current recruitment status is unclear.

Study design
This is a single-arm, two-stage Phase 2 study. It will enroll up to 37 participants to test onvansertib.
What's involved
You would take onvansertib orally for 14 days, followed by 7 days off, in 21-day cycles. Treatment continues until your disease gets worse or side effects become too much.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well the treatment works for up to 42 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05450965

Study of PLK1 Inhibitor, Onvansertib, in Relapsed Small Cell Lung Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Maryland, Baltimore
~37 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:Onvansertib

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate (ORR)
Measured over Up to 42 months (cohort)
Small-cell Lung Cancer
Small Cell Lung Carcinoma
2 sites across 2 states
Maryland1
Pennsylvania1
  • Taofeek Owonikoko, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Maryland, Baltimore

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  • Objective Response Rate (ORR)Up to 42 months (cohort)

    The proportion of patients having either a complete response (CR) or partial response (PR) (as best response), per RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. For non-target lesions, CR is the disappearance of all non-target lesions and normalization of tumor marker level. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.