Study of Palifosfamide-tris in Combination With Carboplatin and Etoposide in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer (The MATISSE Study)
This is a multinational, multicenter, randomized controlled, open-label, adaptive study to evaluate the efficacy of palifosfamide-tris, carboplatin and etoposide (PaCE) chemotherapy in chemotherapy-naive subjects with extensive-stage small cell lung cancer (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 carboplatin and etoposide (CE) chemotherapy. The study design uses an adaptive group sequential approach with sample size re-estimation at the interim analysis. Secondary efficacy endpoints include objective response rate (ORR), progression-free survival (PFS), duration of response and changes in quality of life (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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 2 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 1, 2026 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Alaunos Therapeutics
- Interventions being studied
- Drug: Carboplatin; Drug: Palifosfamide-tris; Drug: Etoposide; Drug: Carboplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Documented extensive-stage small cell lung cancer.
- Patient has received no prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- Adequate bone marrow and organ function based on the results of protocol- specified laboratory tests.
- Male and female patients must agree to use a highly reliable method of birth control during study participation.
- Able to provide informed consent
- Previously untreated (non-irradiated), symptomatic brain metastases.
- Known allergy to any of the study drugs or their excipients.
- Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol, based on screening tests, physical examination and medical history (as specifically defined in the clinical protocol).
- Any malignancy other than small cell lung cancer within the last 5 years prior to randomization, with the exception of cervical carcinoma in situ, nonmelanoma skin cancer, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated with no evidence of recurrent or residual disease. (Exception: Subjects with a history of malignancy other than small cell lung cancer may be enrolled after consultation with the medical monitor provided the patient's prognosis is best defined by the extensive-stage small cell lung cancer).
- Currently pregnant or nursing.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Birmingham Hematology and Oncology Associates, LLCBirmingham, Alabama
- University of Southern CaliforniaLos Angeles, California
- Redwood Regional Oncology GroupSanta Rosa, California
- Christiana Care Health ServicesNewark, Delaware
- Baptist Cancer InstituteJacksonville, Florida
- Hematology Oncology Associates of the Treasure CoastPort Saint Lucie, Florida
- Peachtree Hematology Oncology ConsultantsAtlanta, Georgia
- Rush University Medical CenterChicago, Illinois
- Medical and Surgical Specialists, LLCGalesburg, Illinois
- Illinois Cancer SpecialistsNiles, Illinois
- Central Indiana Cancer CentersFishers, Indiana
- Goshen Center for Cancer CareGoshen, Indiana
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 1, 2026. Always confirm current availability with the study team.