Brief Summary
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.
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.
Brief Title
Study of Palifosfamide-tris in Combination With Carboplatin and Etoposide in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer (The MATISSE Study)
Completion Date
Completion Date Type
Actual
Conditions
EXTENSIVE-STAGE SMALL CELL LUNG CANCER
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
* 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
Exclusion Criteria:
* 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.
Inclusion Criteria
Inclusion Criteria:
* 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01555710
Org Class
Industry
Org Full Name
Alaunos Therapeutics
Org Study Id
IPM3002
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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
Primary Outcomes
Outcome Measure
Overall Survival (OS)
Outcome Time Frame
Assessed every 12 weeks for survival until 1 year following completion of enrollment
Secondary Outcomes
Outcome Time Frame
Assessed every 6 weeks for 22 weeks, then every 12 weeks until progressive disease, initiation of alternate anticancer therapy, or 1 year following the last patient enrolled (whichever is soonest)
Outcome Measure
Progression Free Survival (PFS)
Outcome Time Frame
Assessed every 3 weeks for 22 weeks, then every 12 weeks until 1 year following the last patient enrolled
Outcome Measure
Quality of Life (QOL) as Assessed by the EuroQol 5-Dimension 3-Level Questionnaire (EQ-5D-3L) and the European Organisation for Research and Treatment of Cancer (EORTC) Lung Cancer Module (QLQ-LC13)
Outcome Time Frame
Assessed every 6 weeks for 22 weeks, then every 12 weeks until a partial or complete response is confirmed
Outcome Measure
Objective Response Rate (ORR)
Outcome Time Frame
Time from the date of first objective response (partial or complete response), with subsequent confirmation, until the date of disease progression or the occurrence of death
Outcome Measure
Response Duration
Outcome Time Frame
22 weeks
Outcome Measure
Safety Parameters (Adverse Events and Number of Findings: Physical Examinations, Electrocardiograms [ECGs], Vital Signs, and Clinical Laboratory Results) Using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) 4.03
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Bilal Piperdi
Investigator Email
bpiperdi@montefiore.org
Investigator Phone
BPIPERDI
Categories Mesh Debug
Lung & Chest Cancers --- CARCINOMA, BRONCHOGENIC
Lung & Chest Cancers --- BRONCHIAL NEOPLASMS
Lung & Chest Cancers --- LUNG NEOPLASMS
Lung & Chest Cancers --- RESPIRATORY TRACT NEOPLASMS
Lung & Chest Cancers --- THORACIC NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
COVID-19 --- LUNG DISEASES
Lung --- LUNG DISEASES
Asthma and Other Respiratory Diseases --- RESPIRATORY TRACT DISEASES
COVID-19 --- RESPIRATORY TRACT DISEASES
Lung --- RESPIRATORY TRACT DISEASES
MeSH Terms
SMALL CELL LUNG CARCINOMA
CARCINOMA, BRONCHOGENIC
BRONCHIAL NEOPLASMS
LUNG NEOPLASMS
RESPIRATORY TRACT NEOPLASMS
THORACIC NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
LUNG DISEASES
RESPIRATORY TRACT DISEASES
CARBOPLATIN
ISOPHOSPHAMIDE MUSTARD
ETOPOSIDE
COORDINATION COMPLEXES
ORGANIC CHEMICALS
PODOPHYLLOTOXIN
TETRAHYDRONAPHTHALENES
NAPHTHALENES
POLYCYCLIC AROMATIC HYDROCARBONS
HYDROCARBONS, AROMATIC
HYDROCARBONS, CYCLIC
HYDROCARBONS
POLYCYCLIC COMPOUNDS
GLUCOSIDES
GLYCOSIDES
CARBOHYDRATES