NCT01555710

Study of Palifosfamide-tris in Combination With Carboplatin and Etoposide in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer (The MATISSE Study)

A Multi-center, Open-Label, Adaptive, Randomized Study of Palifosfamide-tris, a Novel DNA Crosslinker, in Combination With Carboplatin and Etoposide (PaCE) Chemotherapy Versus Carboplatin and Etoposide (CE) Alone in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer. The MATISSE Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 548 (estimated)
• Sponsor: Alaunos Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multinational, multicenter, randomized controlled, open-label, adaptive study to evaluate the efficacy of PaCE chemotherapy in chemotherapy naive subjects with extensive-stage SCLC. Eligible subjects will be stratified according to age, gender, and Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio to receive either PaCE or CE chemotherapy. The study design uses an adaptive group sequential approach with sample size re-estimation at the interim analysis. Secondary efficacy endpoints include ORR, PFS, duration of response and changes in QOL and disease-related symptoms. Tumor-related endpoints will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines. The safety of study treatments will be assessed by the frequency and severity of adverse events as determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim analysis of safety data only will be performed. An independent Data Monitoring Committee (DMC) will be convened to assess the safety and efficacy of the study interventions and to monitor the overall conduct of the clinical trial.

Conditions

• Extensive-Stage Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	AUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles.
DRUG	Palifosfamide-tris	130 mg/m2/day 3 days every 21 days for a max of 6 cycles.
DRUG	Etoposide	100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.
DRUG	Carboplatin	AUC 5 mg/mL/min 1 day every 21 days for a max of 6 cycles.

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-03-15
• Last updated: 2013-05-21

Locations

79 sites across 11 countries: United States, Australia, Canada, France, Hungary, Israel, Italy, Poland, Russia, Taiwan, United Kingdom