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

Not Applicable

Not yet recruiting

• Conditions: Small Cell Lung Cancer ( SCLC ); Transformed Small Cell Lung Cancer
• Interventions: Drug: Lurbinectedin; Drug: Osimertinib

• Registration Number: NCT07153055
• Lead Sponsor: Misty Shields

Brief 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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-26
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-09-03
• Last Update Posted: 2025-09-03
• Study Start: 2025-11-01
• Primary Completion: 2029-04
• Study Completion: 2029-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase I Does De-Escalation	Lurbinectedin	3.2 mg/m2 or 2.6 mg/m2 dose of lurbinectedin with 80 mg or 40 mg daily dose of osimertinib. This will occur day 1 of each 21 day cycle.
Phase I Does De-Escalation	Osimertinib	3.2 mg/m2 or 2.6 mg/m2 dose of lurbinectedin with 80 mg or 40 mg daily dose of osimertinib. This will occur day 1 of each 21 day cycle.
Phase II Dose Expansion	Lurbinectedin	3.2 mg/m2 or 2.6 mg/m2 dose of lurbinectedin with 80 mg or 40 mg daily dose of osimertinib. This will occur day 1 of each 21 day cycle.
Phase II Dose Expansion	Osimertinib	3.2 mg/m2 or 2.6 mg/m2 dose of lurbinectedin with 80 mg or 40 mg daily dose of osimertinib. This will occur day 1 of each 21 day cycle.

Primary Outcome Measures

Name	Time	Method
Grade 3 or dose-limiting toxicities	Within 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.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Within 30 days after your last dose of study treatment.	The average length of time of progression-free survival (PFS) of the combination of lurbinectedin with osimertinib.

Trial Locations

Locations (1)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center; 🇺🇸 Indianapolis, Indiana, United States