Phase I/II Trial of Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer
Misty Shields
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).
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria 1. ≥ 18 years old at the time of informed consent. 2. Ability to provide written informed consent and HIPAA authorization. 3. Must have a histologically or cytologically confirmed transformation to small cell lung carcinoma/cancer. 4. Must have an initial diagnosis of EGFR altered (EGFR-mutated) non-small cell lung cancer and received EGFR targeted therapy (TKI) osimertinib, and does not demonstrate evidence of acquired molecular underpinnings (i.e., presence of a MET amplification \>6 copies or EGFR C797S) resulting in progression on osimertinib, aside from histologic tran…
Interventions
- DrugLurbinectedin
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.
- DrugOsimertinib
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.
Location
- Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, Indiana