NCT07153055

Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer

Phase I/II Trial of Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Misty Shields · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, Phase I/II trial is studying the safety and effectiveness of an experimental drug combination, lurbinectedin with osimertinib, against a rare type of cancer known as transformed small cell lung cancer (SCLC).

Detailed description

This is an open label prospective multicenter Phase Ib/II trial utilizing a Bayesian Optimal Interval (BOIN) dose-finding design to identify the maximum tolerated dose (MTD) based on DLTs of lurbinectedin and osimertinib. DLT period is 21 days beginning on C1D1. Once the MTD has been identified, 10 subjects total will be enrolled in a Phase II expansion. This number includes the 3 initial subjects in the corresponding MTD group. Subjects will receive a combination of lurbinectedin every 21 days and osimertinib daily, until progression or unacceptable toxicities.

Conditions

• Small Cell Lung Cancer ( SCLC )
• Transformed Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Lurbinectedin	Two lurbinectedin does of 3.2 mg/m2 or 2.6 mg/m2. The initial starting dose is 3.2 mg/m2. Patients will receive lurbinectedin, until disease progression or unacceptable toxicity, once every 21 days.
DRUG	Osimertinib	Two osimertinib does of 80 mg or 40 mg orally once daily, as assigned by the dose de-escalation cohort for each 21 day cycle.

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-04-01
• Completion: 2029-10-01
• First posted: 2025-09-03
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study