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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Misty D Shields, MD, PhD · PRINCIPAL_INVESTIGATOR · Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Who to contact
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What this trial measures
- 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.