Extensive-Stage Small Cell Lung CancerPhase 3NCT01555710
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 Phase 3 study testing Carboplatin, Palifosfamide-tris and Etoposide in people with Extensive-Stage Small Cell Lung Cancer, run by Alaunos Therapeutics at 79 sites in 11 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extensive-Stage Small Cell Lung Cancer
- What is being tested?
- Carboplatin, Palifosfamide-tris and Etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 79 sitesin 11 countries
- Study dates
- 8 Jun 2012to 2 Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
79 sites in 11 countries.
79 sites in 11 countries
United States40 sites
New York Oncology Hematology, PC
Albany, New York, 12110-2188
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
Peachtree Hematology Oncology Consultants
Atlanta, Georgia, 30318
Medical Oncology, LLC
Baton Rouge, Louisiana, 70809
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, 35205
Fletcher Allen Health Care
Burlington, Vermont, 05405
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, 29403
Rush University Medical Center
Chicago, Illinois, 60612
The Christ Hospital
Cincinnati, Ohio, 45219
Texas Oncology-Medical City Dallas
Dallas, Texas, 75230-6899
Texas Oncology- Baylor, Charles A. Sammons Cancer Center
Dallas, Texas, 75246
Dayton Cancer Center, Medical Oncology Hematology Associates
Dayton, Ohio, 45429
Saint Mary's Medical Center
Duluth, Minnesota, 55805
Fairfax Northern Virginia Hematology-Oncology, PC
Fairfax, Virginia, 22031
Central Indiana Cancer Centers
Fishers, Indiana, 46037
Frederick Memorial Hospital Regional Cancer Therapy Center
Frederick, Maryland, 21701
Medical and Surgical Specialists, LLC
Galesburg, Illinois, 61401
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555-0565
Goshen Center for Cancer Care
Goshen, Indiana, 46526
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Oncology Consultants, PA
Houston, Texas, 77024
Indiana University
Indianapolis, Indiana, 46202
Baptist Cancer Institute
Jacksonville, Florida, 32207
Medical Oncology Associates Of Wyoming Valley, PC
Kingston, Pennsylvania, 18704
Horizon Oncology Center
Lafayette, Indiana, 47905
Central Baptist Hospital
Lexington, Kentucky, 40503
University of Southern California
Los Angeles, California, 90033
Wisconsin Institutes for Medical Research
Madison, Wisconsin, 53705
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407
Hematology Oncology Associates of Northern New Jersey, PA, Carol G. Simon Cancer Center
Morristown, New Jersey, 07962
Indiana University Health Ball Memorial Hospital
Muncie, Indiana, 47303
Christiana Care Health Services
Newark, Delaware, 19713
Illinois Cancer Specialists
Niles, Illinois, 60714-5905
University of Kansas Hospital
Overland Park, Kansas, 66210
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
Redwood Regional Oncology Group
Santa Rosa, California, 95403
Swedish Medical Center
Seattle, Washington, 98104
Montefiore Medical Center
The Bronx, New York, 10461
Texas Oncology, PA
Wichita Falls, Texas, 76310-1610
Metro Health Cancer Center
Wyoming, Michigan, 49519
Russia11 sites
State Institution of Healthcare "Arkhangelsk Regional Clinical Oncology Dispensary"
Arkhangelsk, Primorskiy (Maritime) Kray, 163045
State Budget Institution of Healthcare "Chelyabinsk Regional Clinical Oncology Dispensary"
Chelaybinsk, 454087
Ivanovo Regional Oncology Centre
Ivanovo
Republican Clinical Oncologic Dispensary of Ministry of health of Republic Tatarstan
Kazan', Tatarstan Republic
Cancer Research Center n.a. N.N. Blokhin
Moscow
City Oncology Hospital # 62
Moscow Region, Moscow, 143423
GUZ of Nizhegorodskiy region, Nizhnij Novgorod City Oncology Dispensary
Nizhny Novgorod, 603081
State Educational Institution "S.M. Kirov Military Medical Academy of Ministry of Defense of Russia"
Saint Petersburg, 194044
Saint-Petersburg State Medical University n. a. I. P. Pavlov
Saint Petersburg
Republic Clinical Oncology Dispensary of the Ministry of Healthcare of Republic of Bashkortostan
Ufa, Bashkortostan Republic, 450054
State healthcare institution of Yaroslavl region "Regional Clinical Oncologic Hospital"
Yaroslavl, 150040
France8 sites
Centre Hospitalier Universitaire -Hôpital Morvan
Brest, Brittany Region, 29200
Centre François Baclesse
Caen, Basse-normandie, 14076
Hôpital du Cluzeau
Limoges, Limousin, Lorraine, 87042
Hôpital Saint Joseph
Marseille, Provence-Alpes-Côte d'Azur Region, 13008
Centre Hospitalier Lyon Sud
Pierre Bénité, Auvergne-Rhône-Alpes, 69495
Institut de Cancérologie de l'Ouest - René Gauducheau
Saint-Herblain, Pays de la Loire Region, 44805
Centre Paul Strauss
Strasbourg, 67085
Centre Hospitalier Universitaire, Hopital Bretonneau
Tours, Centre-Val de Loire, 97044
Israel5 sites
Rambam Medical Center
Haifa
Hadassah Medical Organization, Ein Kerem
Jerusalem, 91120
Meir Hospital Sapir Medical Center
Kfar Saba
Western Gallilee Medical Center
Nahariya, 22100
Rabin Medical Center Beilinson Campus
Petah Tikva, 49100
Poland4 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship
Wojewódzkie Centrum Onkologii
Gdansk, Pomeranian Voivodeship
Specjalistyczny Szpital im. Alfreda Sokolowskiego
Szczecin, West Pomeranian Voivodeship
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie w Warszawie
Warsaw, Masovian Voivodeship
Canada3 sites
R. S. McLaughlin Durham Regional Cancer Center at Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
Hôpital Laval
Sainte-Foy, Quebec, G1V 4G5
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Italy3 sites
Istituto Nazionale per la Ricerca sul Cancro
Genova
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milan, 20162
Presidio Ospedaliero S. Chiara
Trento, 38100
Hungary2 sites
Debreceni Egyetem Orvos és Egészségtudományi Centrum
Debrecen, Hajdú-Bihar
Mátrai Gyógyintézet
Mátraháza, Heves County
Australia1 site
Southern Medical Day Oncology Care Centre
Wollongong, New South Wales, 2500
About this 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
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.
Read more
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.
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Being tested
- Carboplatin, Palifosfamide-tris, Etoposide
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
AUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles.
Palifosfamide-trisDrug
130 mg/m2/day 3 days every 21 days for a max of 6 cycles.
EtoposideDrug
100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.
CarboplatinDrug
AUC 5 mg/mL/min 1 day every 21 days for a max of 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Palifosfamide-tris plus Carboplatin and Etoposide | Experimental | 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. Receives: Drug: Carboplatin; Drug: Palifosfamide-tris; Drug: Etoposide |
| Carboplatin plus Etoposide | Active comparator | 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. Receives: Drug: Etoposide; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: Assessed every 12 weeks for survival until 1 year following completion of enrollment
Secondary outcomes (5)
Progression Free Survival (PFS)
Measured: 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)
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)
Measured: Assessed every 3 weeks for 22 weeks, then every 12 weeks until 1 year following the last patient enrolled
Objective Response Rate (ORR)
Measured: Assessed every 6 weeks for 22 weeks, then every 12 weeks until a partial or complete response is confirmed
Response Duration
Measured: 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
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
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study start8 Jun 2012
- Primary completion2 Dec 2014
- Study completion2 Dec 2014
Why it stopped: Sponsor closed enrollment in April 2013 following a change in the palifosfamide development plan (business decision), not for safety reasons. Enrolled participants continued treatment and were followed for survival
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extensive-Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555710
- Sponsor's protocol ID
- IPM3002
- Status last verified
- Sep 2026
- First submitted
- 12 Mar 2012
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01555710
- Acronym / sponsor ID
- IPM3002
- Conditions
- Extensive-Stage Small Cell Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor closed enrollment in April 2013 following a change in the palifosfamide development plan (business decision), not for safety reasons. Enrolled participants continued treatment and were followed for survival
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2012 (actual)
- Primary completion
- 2 Dec 2014 (actual)
- Study completion
- 2 Dec 2014 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palifosfamide-tris plus Carboplatin and Etoposide | Experimental | Drug: Carboplatin, Drug: Palifosfamide-tris, Drug: EtoposideDrug: 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. |
| Carboplatin plus Etoposide | Active comparator | Drug: Etoposide, Drug: CarboplatinDrug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinAUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles. | Drug | Palifosfamide-tris plus Carboplatin and Etoposide |
| Palifosfamide-tris130 mg/m2/day 3 days every 21 days for a max of 6 cycles. | Drug | Palifosfamide-tris plus Carboplatin and Etoposide |
| Etoposide100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles. | Drug | Carboplatin plus Etoposide, Palifosfamide-tris plus Carboplatin and Etoposide |
| CarboplatinAUC 5 mg/mL/min 1 day every 21 days for a max of 6 cycles. | Drug | Carboplatin plus Etoposide |
Primary outcome
Overall Survival (OS)
Time frame: Assessed every 12 weeks for survival until 1 year following completion of enrollment
5 secondary outcomes
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)
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)
Time frame: Assessed every 3 weeks for 22 weeks, then every 12 weeks until 1 year following the last patient enrolled
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
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
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
Time frame: 22 weeks
Results and safety
The study was stopped early (reason given: Sponsor closed enrollment in April 2013 following a change in the palifosfamide development plan (business decision), not for safety reasons. Enrolled participants continued treatment and were followed for survival). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
79 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carboplatin, Palifosfamide-tris and Etoposide in people with Extensive-Stage Small Cell Lung Cancer, run by Alaunos Therapeutics at 79 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Russia, France, Israel, Poland and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor closed enrollment in April 2013 following a change in the palifosfamide development plan (business decision), not for safety reasons. Enrolled participants continued treatment and were followed for survival). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Assessed every 12 weeks for survival until 1 year following completion of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.