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

Primary Purpose

Extensive-Stage Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Carboplatin
Palifosfamide-tris
Etoposide
Carboplatin
Sponsored by
Alaunos Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extensive-Stage Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented extensive-stage small cell lung cancer.
  • Patient has received no prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer.
  • 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.

Sites / Locations

  • Birmingham Hematology and Oncology Associates, LLC
  • University of Southern California
  • Redwood Regional Oncology Group
  • Christiana Care Health Services
  • Baptist Cancer Institute
  • Hematology Oncology Associates of the Treasure Coast
  • Peachtree Hematology Oncology Consultants
  • Rush University Medical Center
  • Medical and Surgical Specialists, LLC
  • Illinois Cancer Specialists
  • Central Indiana Cancer Centers
  • Goshen Center for Cancer Care
  • Indiana University
  • Horizon Oncology Center
  • Indiana University Health Ball Memorial Hospital
  • University of Kansas Hospital
  • Central Baptist Hospital
  • Medical Oncology, LLC
  • Frederick Memorial Hospital Regional Cancer Therapy Center
  • Metro Health Cancer Center
  • Saint Mary's Medical Center
  • Virginia Piper Cancer Institute
  • John Theurer Cancer Center at Hackensack University Medical Center
  • Hematology Oncology Associates of Northern New Jersey, PA, Carol G. Simon Cancer Center
  • University of New Mexico Cancer Center
  • New York Oncology Hematology, PC
  • Montefiore Medical Center
  • The Christ Hospital
  • Dayton Cancer Center, Medical Oncology Hematology Associates
  • Medical Oncology Associates Of Wyoming Valley, PC
  • Charleston Hematology Oncology Associates, PA
  • Texas Oncology-Medical City Dallas
  • Texas Oncology- Baylor, Charles A. Sammons Cancer Center
  • University of Texas Medical Branch at Galveston
  • Oncology Consultants, PA
  • Texas Oncology, PA
  • Fletcher Allen Health Care
  • Fairfax Northern Virginia Hematology-Oncology, PC
  • Swedish Medical Center
  • Wisconsin Institutes for Medical Research
  • Southern Medical Day Oncology Care Centre
  • CancerCare Manitoba
  • R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa
  • Hôpital Laval
  • Centre François Baclesse
  • Centre Hospitalier Universitaire -Hôpital Morvan
  • Centre Hospitalier Universitaire, Hopital Bretonneau
  • Hôpital du Cluzeau
  • Institut de Cancérologie de l'Ouest - René Gauducheau
  • Hôpital Saint Joseph
  • Centre Hospitalier Lyon Sud
  • Centre Paul Strauss
  • Debreceni Egyetem Orvos és Egészségtudományi Centrum
  • Mátrai Gyógyintézet
  • Rambam Medical Center
  • Hadassah Medical Organization, Ein Kerem
  • Meir Hospital Sapir Medical Center
  • Western Gallilee Medical Center
  • Rabin Medical Center Beilinson Campus
  • Istituto Nazionale per la Ricerca sul Cancro
  • Azienda Ospedaliera Ospedale Niguarda Ca' Granda
  • Presidio Ospedaliero S. Chiara
  • Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie
  • Uniwersyteckie Centrum Kliniczne
  • Wojewódzkie Centrum Onkologii
  • Specjalistyczny Szpital im. Alfreda Sokolowskiego
  • Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan
  • City Oncology Hospital # 62
  • State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
  • Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
  • State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"
  • Ivanovo Regional Oncology Centre
  • Cancer Research Center n.a. N.N. Blokhin
  • GUZ of Nizhegorodskiy region, Nizhnij Novgorod City Oncology Dispensary
  • State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"
  • Saint-Petersburg State Medical University n. a. I. P. Pavlov
  • State healthcare institution of Yaroslavl region "Regional Clinical Oncologic Hospital"
  • China Medical University Hospital
  • Wythenshawe Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Palifosfamide-tris plus Carboplatin and Etoposide

Carboplatin plus Etoposide

Arm Description

Drug: palifosfamide-tris in combination with carboplatin and etoposide palifosfamide-tris: 130 mg/m2/day 3 days every 21 days for a max of 6 cycles. carboplatin: AUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles. etoposide: 100 mg/m2/day 3 days every 21 days for a max of 6 cycles.

Drug: carboplatin in combination with etoposide carboplatin: AUC 5mg/mL/min 1 day every 21 days for a maximum of 6 cycles. etoposide: 100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.

Outcomes

Primary Outcome Measures

Overall Survival (OS)

Secondary Outcome Measures

Progression Free Survival (PFS)
Quality of Life (QOL) as assessed by EQ-5D-3L and QLQ-LC13
Objective Response Rate (ORR)
Response Duration
Safety parameters (number of adverse events as well as number of findings from physical examinations, ECGs, vital signs, and clinical laboratory results)using NCI CTCAE v. 4.03

Full Information

First Posted
March 12, 2012
Last Updated
May 20, 2013
Sponsor
Alaunos Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01555710
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)
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alaunos Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive-Stage Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
548 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Palifosfamide-tris plus Carboplatin and Etoposide
Arm Type
Experimental
Arm Description
Drug: palifosfamide-tris in combination with carboplatin and etoposide palifosfamide-tris: 130 mg/m2/day 3 days every 21 days for a max of 6 cycles. carboplatin: AUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles. etoposide: 100 mg/m2/day 3 days every 21 days for a max of 6 cycles.
Arm Title
Carboplatin plus Etoposide
Arm Type
Active Comparator
Arm Description
Drug: carboplatin in combination with etoposide carboplatin: AUC 5mg/mL/min 1 day every 21 days for a maximum of 6 cycles. etoposide: 100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
AUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Palifosfamide-tris
Intervention Description
130 mg/m2/day 3 days every 21 days for a max of 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
AUC 5 mg/mL/min 1 day every 21 days for a max of 6 cycles.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
Assessed every 12 weeks for survival until 1 year following completion of enrollment
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
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)
Title
Quality of Life (QOL) as assessed by EQ-5D-3L and QLQ-LC13
Time Frame
Assessed every 3 weeks for 22 weeks, then every 12 weeks until 1 year following the last patient enrolled
Title
Objective Response Rate (ORR)
Time Frame
Assessed every 6 weeks for 22 weeks, then every 12 weeks until a partial or complete response is confirmed
Title
Response Duration
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
Title
Safety parameters (number of adverse events as well as number of findings from physical examinations, ECGs, vital signs, and clinical laboratory results)using NCI CTCAE v. 4.03
Time Frame
22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented extensive-stage small cell lung cancer. Patient has received no prior chemotherapy, adjuvant therapy, or radiotherapy for lung cancer. 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.
Facility Information:
Facility Name
Birmingham Hematology and Oncology Associates, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Redwood Regional Oncology Group
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Baptist Cancer Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Hematology Oncology Associates of the Treasure Coast
City
Port Sant Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Peachtree Hematology Oncology Consultants
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Medical and Surgical Specialists, LLC
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois Cancer Specialists
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714-5905
Country
United States
Facility Name
Central Indiana Cancer Centers
City
Fishers
State/Province
Indiana
ZIP/Postal Code
46037
Country
United States
Facility Name
Goshen Center for Cancer Care
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Horizon Oncology Center
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Indiana University Health Ball Memorial Hospital
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
University of Kansas Hospital
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Medical Oncology, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Frederick Memorial Hospital Regional Cancer Therapy Center
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21701
Country
United States
Facility Name
Metro Health Cancer Center
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Saint Mary's Medical Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
John Theurer Cancer Center at Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Hematology Oncology Associates of Northern New Jersey, PA, Carol G. Simon Cancer Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
New York Oncology Hematology, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12110-2188
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Dayton Cancer Center, Medical Oncology Hematology Associates
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Medical Oncology Associates Of Wyoming Valley, PC
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Charleston Hematology Oncology Associates, PA
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Texas Oncology-Medical City Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230-6899
Country
United States
Facility Name
Texas Oncology- Baylor, Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas Medical Branch at Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0565
Country
United States
Facility Name
Oncology Consultants, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Texas Oncology, PA
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76310-1610
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
Fairfax Northern Virginia Hematology-Oncology, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Wisconsin Institutes for Medical Research
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Southern Medical Day Oncology Care Centre
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Hôpital Laval
City
Sainte Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Centre François Baclesse
City
Caen
State/Province
Basse-normandie
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Hospitalier Universitaire -Hôpital Morvan
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29200
Country
France
Facility Name
Centre Hospitalier Universitaire, Hopital Bretonneau
City
Tours cedex 1
State/Province
Centre
ZIP/Postal Code
97044
Country
France
Facility Name
Hôpital du Cluzeau
City
Limoges
State/Province
Limousin, Lorraine
ZIP/Postal Code
87042
Country
France
Facility Name
Institut de Cancérologie de l'Ouest - René Gauducheau
City
Saint Herblain
State/Province
Pays de La Loire
ZIP/Postal Code
44805
Country
France
Facility Name
Hôpital Saint Joseph
City
Marseille
State/Province
Provence Alpes Cote D'azur
ZIP/Postal Code
13008
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Bénité
State/Province
Rhone-alpes
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Paul Strauss
City
Strasbourg
ZIP/Postal Code
67085
Country
France
Facility Name
Debreceni Egyetem Orvos és Egészségtudományi Centrum
City
Debrecen
State/Province
Hajdu-bihar
Country
Hungary
Facility Name
Mátrai Gyógyintézet
City
Mátraháza
State/Province
Heves
Country
Hungary
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Hadassah Medical Organization, Ein Kerem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir Hospital Sapir Medical Center
City
Kfar Saba
Country
Israel
Facility Name
Western Gallilee Medical Center
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Rabin Medical Center Beilinson Campus
City
Petah Tiqwa
ZIP/Postal Code
49100
Country
Israel
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genova
Country
Italy
Facility Name
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Presidio Ospedaliero S. Chiara
City
Trento
ZIP/Postal Code
38100
Country
Italy
Facility Name
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie
City
Warszawa
State/Province
Mazowieckie
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
State/Province
Pomorskie
Country
Poland
Facility Name
Wojewódzkie Centrum Onkologii
City
Gdansk
State/Province
Pomorskie
Country
Poland
Facility Name
Specjalistyczny Szpital im. Alfreda Sokolowskiego
City
Szczecin
State/Province
Zachodniopomorskie
Country
Poland
Facility Name
Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan
City
Ufa
State/Province
Bashkortostan
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
City Oncology Hospital # 62
City
Moscow Region
State/Province
Moscow
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
City
Arkhangelsk
State/Province
Primorskiy
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
City
Kazan
State/Province
Tatarstan
Country
Russian Federation
Facility Name
State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"
City
Chelaybinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Ivanovo Regional Oncology Centre
City
Ivanovo
Country
Russian Federation
Facility Name
Cancer Research Center n.a. N.N. Blokhin
City
Moscow
Country
Russian Federation
Facility Name
GUZ of Nizhegorodskiy region, Nizhnij Novgorod City Oncology Dispensary
City
Nizhny Novgorod
ZIP/Postal Code
603081
Country
Russian Federation
Facility Name
State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"
City
Saint Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Saint-Petersburg State Medical University n. a. I. P. Pavlov
City
Saint-Petersburg
Country
Russian Federation
Facility Name
State healthcare institution of Yaroslavl region "Regional Clinical Oncologic Hospital"
City
Yaroslavl
ZIP/Postal Code
150040
Country
Russian Federation
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Wythenshawe Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M23 9LT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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