Lurbinectedin with Osimertinib for Transformed Small Cell Lung Cancer

This study is looking at the safety and effectiveness of combining two drugs, lurbinectedin and osimertinib, for a rare type of cancer called transformed small cell lung cancer (SCLC). This cancer starts as non-small cell lung cancer with a specific genetic change (EGFR mutation) and then changes into SCLC. To join, you must be at least 18 years old and have this specific type of cancer. The study will look at how well participants tolerate the drugs and if there are any serious side effects. The goal is to find the best dose of these drugs when given together. The study plans to enroll 16 participants.

Study design
This is an open-label, Phase I/II study, meaning you and your doctors will know which treatments you are receiving. It is designed to find the maximum tolerated dose of the drug combination and will enroll 16 participants.
What's involved
You will receive lurbinectedin every 21 days and osimertinib daily. Treatment will continue until your disease progresses or you experience side effects that are too difficult to manage.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for safety is measured within 30 days after your last dose of study treatment.

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NCT07153055

Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Misty Shields
~16 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:LurbinectedinOsimertinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Grade 3 or dose-limiting toxicities
Measured over Within 30 days after your last dose of study treatment.
Small Cell Lung Cancer ( SCLC )
Transformed Small Cell Lung Cancer
1 sites across 1 states
Indiana1
  • Misty D Shields, MD, PhD · PRINCIPAL_INVESTIGATOR · Indiana University Melvin and Bren Simon Comprehensive Cancer Center

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  • Grade 3 or dose-limiting toxicitiesWithin 30 days after your last dose of study treatment.

    The number of incidences of grade 3 or dose-limiting toxicities of the combination of lurbinectedin with osimertinib assessed using NCI CTCAE v5.0 criteria.