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Non Small Cell Lung CancerPhase 3ATALANTE-1NCT02654587

OSE2101 Versus Chemotherapy in HLA-A2 Positive Patients With Advanced NSCLC After Immune Checkpoint Inhibitor Failure

A Phase 3 study testing OSE2101, Docetaxel and Pemetrexed in people with Non Small Cell Lung Cancer, run by OSE Immunotherapeutics at 78 sites in 10 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The aim of this clinical trial was to determine if the therapeutic cancer vaccine OSE2101 (TEDOPI) was more effective than standard chemotherapy (docetaxel or pemetrexed) in treating HLA-A2 positive patients with metastatic NSCLC who progressed after sequential or concurrent chemotherapy and immune checkpoint… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
OSE2101, Docetaxel and Pemetrexed
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
219 participants
Where
78 sitesin 10 countries
Study dates
12 Feb 2016to 15 Jan 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Signed and dated informed consent
  • Willingness and ability to comply with the clinical study procedures.
  • Female or male, 18 years of age or older
  • Histologically or cytologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced (stage III) unsuitable for radiotherapy or metastatic (stage IV) according to the 8th edition of tumor, node, metastasis (TNM) in Lung Cancer
  • Subjects with disease recurrence or progression after immune checkpoint inhibitor and platinum-based chemotherapy:
  • either 1st line chemotherapy followed by 2nd line immune checkpoint inhibitor, or ii) 1st line combination of immune checkpoint inhibitor and chemotherapy Patients with progression during or within 12 months after the end of immune checkpoint inhibitor given as sequential or concomitant platinum-based chemotherapy ± radiation for locally advanced disease (stage III) were eligible
Show all 21Show fewer
  • Subjects with measurable or non-measurable lesions according to RECIST 1.1
  • Subjects must express HLA-A2 phenotype (central test in blood)
  • Subjects must be considered suitable for chemotherapy with single-agent pemetrexed or single-agent docetaxel
  • Subjects with brain metastases were eligible if treated (whole brain radiotherapy, stereotaxic radiotherapy, surgery) at least 3 weeks prior to initiation of study treatment and have no symptoms related to brain metastases for at least 2 weeks before initiation of study treatment and are not taking any forbidden medications
  • Any prior chemotherapy, immunotherapy, hormonal therapy, radiation therapy or surgeries must have been completed at least 3 weeks prior to initiation of study treatment.
  • Any toxicity from prior therapy must have recovered to ≤ Grade 1 (except alopecia)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Adequate organ function as defined by all the following criteria:
  • Albuminemia > 25g/L
  • Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 1.5 x upper limit of normal (ULN) with alkaline phosphatase ≤ 2.5 x ULN, or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to liver metastases
  • Total serum bilirubin ≤ 1.5 x ULN
  • Absolute neutrophil count (ANC) ≥ 1500/L
  • Platelets ≥ 100000/L
  • Hemoglobin ≥ 9.0 g/dL (in the absence of transfusion within 2 weeks before randomization)
  • Creatinine clearance (based on modified Cockcroft-Gault formula) ≥ 45 ml/min.

Who cannot join

  • Small-cell lung cancer/mixed NSCLC with small cell component or other neuroendocrine lung cancers (typical and atypical carcinoids, large-cell neuroendocrine carcinomas)
  • Patients with squamous cell carcinoma histology, and who had docetaxel as part of his prior chemotherapy
  • Current or previous treatment with investigational therapy in another therapeutic clinical trial (interrupted less than 4 weeks before study treatment initiation)
  • Patients whose tumor harbors EGFR gene mutation that sensitizes tumors to Tyrosine-Kinase Inhibitor (TKI) (EGFR exon 18-21) or Anaplastic Lymphoma Kinase (ALK) rearrangement
  • Ongoing immunotherapy (checkpoint inhibition, antigen immunotherapy that would be scheduled to continue concomitantly to the study)
  • Spinal cord compression (unless treated with the patient attaining good pain control and stable or recovered neurologic function), carcinomatous meningitis, or leptomeningeal disease
Show all 19Show fewer
  • Patients with squamous cell histology or non-squamous cell histology previously treated by pemetrexed with a contraindication for docetaxel with grade ≥ 2 neuropathy or hypersensitivity reaction to medications formulated with polysorbate 80 (Tween 80)
  • Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
  • Treatment with corticosteroids in the last 3-week period before inclusion, except for topical, ocular, intra-articular, intranasal, and inhaled corticosteroids with minimal systemic absorption (e.g. with a dose ≤ 500 microgram beclomethasone equivalent for inhaled steroids), or steroid doses ≤ 10 mg daily prednisone equivalent which are permitted
  • A recognized immunodeficiency disease including human immunodeficiency virus (HIV) infection (and other cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary, congenital or acquired immunodeficiencies)
  • Patients with auto-immune disease, with the exception of type I diabetes or treated hypothyroidism
  • Patients with interstitial lung disease
  • Patients with active B or C hepatitis
  • Other malignancy: patients will not be eligible if they have evidence of other active invasive cancer(s) (other than NSCLC) within 5 years prior to screening (except appropriately treated non-melanoma skin cancer or localized cervical cancer, or other local tumors considered cured (e.g.localized and presumed cured prostate cancer)
  • Other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that would impart, in the judgment of the investigator and/or sponsor, excess risk associated with study participation or study drug administration, and which would, therefore, make the patient inappropriate for entry into this study
  • Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment
  • Male patients sexually active with a woman of childbearing potential must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator
  • Breastfeeding women
  • Women with a positive pregnancy test.

Trial locations and contacts

78 sites in 10 countries.

78 sites in 10 countries

France24 sites

  • Institut Saint Catherine

    Avignon, 84918

  • Hôpital Avicenne

    Bobigny, 93000

  • Institut Bergonié

    Bordeaux, 33076

  • CHGU Morvan - Brest

    Brest, 29200

  • Hôpital Louis Pradel

    Bron, 69500

  • Centre Hospitalier de Cholet

    Cholet, 49300

  • Hôpital intercommunal de Créteil

    Créteil, 94010

  • CHU Grenoble

    Grenoble, 38043

  • Clinique Victor Hugo

    Le Mans, 72000

  • Centre Hospitalier du Mans

    Le Mans, 72037

  • Hopital Albert Calmette

    Lille, 59000

  • Paoli-Calmettes Institute

    Marseille, 13273

  • CHU Montpellier

    Montpellier, 34295

  • Hôpital Emile Muller

    Mulhouse, 68100

  • Centre Catherine de Sienne

    Nantes, 44277

  • Hôpital Saint-Louis

    Paris, 75010

  • Hôpital Bichat - Claude-Bernard

    Paris, 75018

  • Hôpital Tenon

    Paris, 75970

  • Hôpital d'Instruction des Armées Bégin

    Saint-Mandé, 94160

  • CHU de Strasbourg - Hôpital Civil

    Strasbourg, 67091

  • Hôpital Larrey - CHU de Toulouse

    Toulouse, 31059

  • Centre Hospitalier Régional Universitaire de Tours

    Tours, 37044

  • Centre Hospitalier Troyes

    Troyes, 10003

  • Institut Gustave Roussy (IGR)

    Villejuif, 94805

Other trials in France

Italy13 sites

  • IRCCS Oncologico Giovanni Paolo II

    Bari, 70124

  • Unità Operativa di Oncologia dell'Ospedale Vito Fazzi di Lecce, Piazza Muratore

    Lecce, 73100

  • Oncologia medica

    Legnano, 37045

  • Azienda USL 2 Lucca - Dipartimento Oncologico

    Lucca, 56124

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T)

    Meldola, 47014

  • U.O.C. Pneumologia a indirizzo oncologico, Presidio Ospedaliero Monaldi - Azienda Ospedaliera dei Colli - Via Leonardo Bianchi

    Naples, 80131

  • Istituto Oncologico Veneto, IRCCS

    Padova, 35128

  • Ospedale di Perugia - Oncologia medica

    Perugia, 06126

  • U.O. Oncologia Ospedale Infermi

    Rimini, 47923

  • UOC di Oncologia Medica, Policlinico Universitario Campus Biomedico

    Roma, 00128

  • IRCCS Regina Elena National Cancer Institute

    Roma, 119

  • Policlinico Santa Maria alle Scotte

    Siena, 53100

  • Ospedale Civile Maggiore

    Verona, 37126

Other trials in Italy

United States10 sites

  • BRCR Medical Center, Inc

    Boca Raton, Florida, 33322

  • East Valley Hematology and Oncology medical Group

    Burbank, California, 91505

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • Pontchartrain Cancer Center

    Covington, Louisiana, 70433

  • Gesinger Medical Center

    Danville, Pennsylvania, 17822

  • Millenium Oncology

    Houston, Texas, 77090

  • Meyer Cancer Center, Weill Cornell Medecine

    New York, New York, 100001

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Robert W. Franz Cancer Center

    Portland, Oregon, 97225

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

Spain9 sites

  • "Complejo Hospitalario Universitario A Coruna (CHUAC)"

    A Coruña, 15006

  • Hospital Universitari Quirón Dexeus

    Barcelona, 08028

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035

  • Hospital de Mataro

    Barcelona, 08304

  • Hospital Universitario Germans Trias i Pujol

    Barcelona, 08916

  • Hospital Universitario La Paz Servicio de Oncología Médica

    Madrid, 28046

  • Hospital Universitario Puerta de Hierro Majadahonda Servicio de Oncología Médica Consultas externas, 2ª planta

    Madrid, 28220

  • Hospital Universitario Carlos Haya

    Málaga, 29010

  • Hospital de Mataro

    Mataró, 08304

Other trials in Spain

Hungary6 sites

  • Magyar Honvedseg Egeszsegugyi Kozpont II szamu telephely

    Budapest, 1062

  • Országos Korányi TBC és Pulmonológiai Intézet XI Tüdőbelosztály

    Budapest, 1121

  • Országos Korányi TBC és Pulmonológiai Intézet XIV Tüdőbelosztály

    Budapest, 1121

  • Semmelweis Egyetem Altalanos Orvostudományi Kar Pulmonologiai Klinika

    Budapest, 1125

  • Csongrad Megyei Mellkasi Betegsegek Szakkorháza I Tüdőosztály

    Deszk, 6772

  • Matrai Gyogyintézet

    Mátraháza, 3233

Other trials in Hungary

Israel5 sites

  • Soroka University Medical Center

    Beersheba, 84101

  • Rambam Health Care Campus

    Haifa, 3109601

  • Hadassah Campus Ein Kerem

    Jerusalem, 9087200

  • Meir Medical Center

    Kfar Saba, 44281

  • Rabin (Belinson) Medical Center

    Petah Tikva, 4941492

Other trials in Israel

Germany4 sites

  • Krankenhaus Mehrheit - Kliniken der Stadt Köln - Lungenklinik

    Cologne, 51109

  • Klinik für Innere Medizin II Hospital Martha-Maria Halle-Dölau gGmbH

    Halle, 06120

  • Universitätsklinikum Tübingen Medizinische Klinik II

    Tübingen, 72076

  • Klinik für Innere Medizin II Universitätsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Poland4 sites

  • Klinika Onkologii i Radioterapii , Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Przychodnia Lekarska "KOMED"

    Konin, 62-500

  • Mazowieckie Centrum Leczenia chorób Płuc i Gruźlicy

    Otwock

  • Wojewódzki Szpital Zespolony , Oddział Chemioterapii Nowotworów

    Torun, 87-100

Other trials in Poland

Czechia2 sites

  • Nemocnice Jihlava, Onkologické oddelení

    Jihlava, 58633

  • Všeobecná Fakultní nemocnice

    Prague, 12808

Other trials in Czechia

United Kingdom1 site

  • Milton Keynes Hospital

    Milton Keynes, MK6 5LD

Other trials in United Kingdom

About this study

Official title: A Randomized Phase III Trial of OSE2101 Compared With Chemotherapy (Docetaxel or Pemetrexed) in HLA-A2 Positive Patients With Advanced Non-Small Cell Lung Cancer With Progressive Disease After Immune Checkpoint Inhibitors

The aim of this clinical trial was to determine if the therapeutic cancer vaccine OSE2101 (TEDOPI) was more effective than standard chemotherapy (docetaxel or pemetrexed) in treating HLA-A2 positive patients with metastatic NSCLC who progressed after sequential or concurrent chemotherapy and immune checkpoint inhibitor given in first or second-line treatment.

The main questions were to compare the survival, the tolerance to treatment and the quality of life of patients between the two arms of treatment (OSE2101 versus standard chemotherapy)

Read the detailed description

The study was a two-step randomized (2:1) study. Patients were stratified by histology (non-squamous versus squamous), best response to first-line treatment [complete response or partial response versus stable disease or progressive disease] and line of treatment with prior ICI (first-line ICI when combined with platinum-based chemotherapy versus second-line ICI when administered as sequential treatment). Primary endpoint was overall survival (OS). Interim OS futility analysis was planned as per Fleming design. In April 2020 at the time of the interim analysis, a decision was taken to early stop the accrual due to COVID-19 after 219 out of 363 patients were randomized. It led to a decrease of the study power from 80% to 62%. At the time of the interim analysis, a subgroup of patients was identified from stratification factor based on a clinical and biological rationale: those who received ICI second line and having received at least 12 weeks ICI. This subgroup was defined as ICI secondary resistance. The final analysis was carried out in the subgroup of patients with ICI secondary resistance and in all patients (ICI primary and secondary resistance).

Being tested
OSE2101, Docetaxel, Pemetrexed
Keywords
Advanced Non-Small-Cell Lung Cancer, Therapeutic Cancer Vaccine, Resistance to Immunotherapy, Quality of Life
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OSE2101Biological

    Also called TEDOPI, EP-2101, EP2101, IDM-2101

  • DocetaxelDrug

    Also called Taxotere

  • PemetrexedDrug

    Also called Alimta

Study groups in NCT02654587
Study groupRoleWhat they receive
OSE2101ExperimentalOSE2101 was administered as a 1 mL-subcutaneous injection on Day 1 every three weeks for six cycles, then every eight weeks for the remainder of year one and finally every twelve weeks beyond year one until unequivocal RECIST 1.1-defined disease progression as determined by the investigator, unacceptable toxicity, or consent withdrawal. Should pseudo progression or delayed response to treatment suspected in arm A, investigator may continue treatment beyond the time of RECIST-defined progression, if the patient is perceived to be experiencing clinical benefit of OSE2101. OSE2101 dose was 5 mg of peptides (0.5 mg for each peptide).
Receives: Biological: OSE2101
Docetaxel or PemetrexedActive comparatorPatients receiving docetaxel: Docetaxel 75 mg/m2 will be administered by intravenous infusion over 1 hour on Day 1 of a 21-day cycle. Patients receiving pemetrexed: Pemetrexed, 500 mg/m2, will be administered by intravenous infusion over 10 minutes on Day 1 of a 21-day cycle. Docetaxel and pemetrexed will be continued until unequivocal RECIST 1.1-defined disease progression as determined by the investigator, unacceptable toxicity, or consent withdrawal.
Receives: Drug: Docetaxel; Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    OS defined as the time from randomisation to death from any cause in patients with ICI secondary resistance

    Measured: Approx. 24 months

Secondary outcomes (7)

  1. Post-Progression Survival

    Post-progression survival was defined as the time from the earliest date of progression according to RECIST 1.1 until death in patients with ICI secondary resistance

    Measured: approximately 24 months

  2. Time to Worsening ECOG PS

    Time to Worsening ECOG PS was defined as the time from randomization to the earliest date when ECOG PS was >1 in patients with ICI secondary resistance. Time to worsening ECPG PS was summarized by treatment arm using the Kaplan-Meier method. The median event time for each treatment arm and the corresponding 2-sided 95% confidence interval were provided. By protocol, ECOG PS was not collected when a patient permanenetly discontinued the study treatment. Patients without ECOG PS worsening were censored at the last time when an ECOG value was recorded.

    Measured: Approx. 24 months

  3. Mean Changes in Functional Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance

    Mean change from baseline to treatment discontinuation in Quality of Life (QoL) score of the following functional subscales analyzed separately: global health status, physical, role, cognitive, emotional and social functioning. Each score range from 0 to 100 after normalisation. Highest scores correspond to a better quality of life. The mean score change was assessed using a mixed-effects model for repeated measures analysis with the patient as the random effect, treatment, visit and treatment-by-visit interaction as explanatory variables and baseline score as covariates. If the mean score change is negative, it means a deterioration of QoL. If the mean score change is positive or 0, it means an improvement or stability of QoL

    Measured: Approx. 24 months

  4. Mean Changes in Symptoms Subscales of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance

    Mean change from baseline to treatment discontinuation in Quality of Life (QoL) score of the following symptoms subscales analyzed separately: Fatigue, Constipation, Dyspnea, Nausea and Vomiting, Pain, Insomnia, Appetite loss, Diarrhea, Financial Difficulties. Each score range from 0 to 100 after normalisation. Lowest scores correspond to a better QoL. The mean score change was assessed using a mixed-effects model for repeated measures analysis with the patient as the random effect, treatment, visit and treatment-by-visit interaction as explanatory variables and baseline score as covariates. If the mean score change is negative, it means a deterioration of QoL. If the mean score change is positive or 0, it means an improvement or stability of QoL.

    Measured: Approx. 24 months

  5. Mean Changes in Symptoms Subscales of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Lung Cancer (QLQ-LC13) From Baseline to Treatment Discontinuation in Patients With ICI Secondary Resistance

    Mean change from baseline to treatment discontinuation in Quality of Life (QoL) score of the following symptoms subscales analyzed separately: Alopecia, Peripheral Neuropathy, Sore mouth, Dysphagia, Dyspnea, Pain in arm or shoulder, Pain in chest, Pain in other parts, Hemoptysis, Coughing. Each score range from 0 to 100 after normalisation. Lowest scores correspond to a better QoL. The mean score change was assessed using a mixed-effects model for repeated measures analysis with the patient as the random effect, treatment, visit and treatment-by-visit interaction as explanatory variables and baseline score as covariates. If the mean score change is negative, it means a deterioration of QoL. If the mean score change is positive or 0, it means an improvement or stability of QoL.

    Measured: Approx. 24 months

  6. Disease Control Rate (DCR) at 6 Months

    DCR at 6 months defined as the number of patients with Complete Response (CR), Partial Response (PR) or Stable Disease (SD) assessed by investigator per "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions based on CT scan in patients with ICI secondary resistance. Complete Response (CR) defined as disappearance of all target lesions; Partial Response (PR) as >=30% decrease in the sum of the longest diameter of target lesions; Stable disease (SD) defined as neither sufficient shrinkage (compared to baseline) to qualify for CR or PR nor sufficient increase (taking as reference the smallest sum of diameters at baseline or while on study, whichever is smallest) to qualify for progressive disease (PD) (e.g. decrease of the sum of the longest diameters of target lesions <30% or increase up to 20%)

    Measured: Approx. 6 months

  7. Progression Free Survival (PFS) in Patients With ICI Secondary Resistance

    PFS was defined as the time from randomization to the earliest date of progression assessed by investigator per "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions based on CT scan in patients with ICI secondary resistance. Progressive disease (PD) defined as increase of target lesions >=20% taking as reference the smallest sum of diameters at baseline or while on study, whichever is smallest)

    Measured: Approx. 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2016 (estimated)
  2. Study start12 Feb 2016
  3. Primary completion15 Jan 2021
  4. Study completion15 Jan 2021

Why it stopped: due to COVID-19

Resources

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
Model description
Two-step open-label study with a planned interim OS futility in experimental arm per Fleming design (Step1) Central randomisation (2:1) with stratification by histology (non-squamous versus squamous), best response to first-line treatment \[complete response (CR) or partial response (PR) versus stable disease (SD) or PD\] and line of prior anti-PD(L)1 treatment (first-line when combined with platinum-based chemotherapy versus second-line when administered as sequential treatment after first-line platinum-based chemotherapy).
Masking
None (open label)
Enrolment
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02654587
Sponsor's protocol ID
OSE2101C301
Other IDs
2015-003183-36, 2015
Acronym
ATALANTE-1
Status last verified
Jan 2024
First submitted
8 Jan 2016
Last updated
2 Feb 2024
Data monitoring committee
Yes
Individual data sharing
No: The supporting information as Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR) may be shared with other researchers if OSE Immunotherapeutics agreed and after signature of a confidential agreement between the parties

Publications

  • Besse B, Felip E, Garcia Campelo R, Cobo M, Mascaux C, Madroszyk A, Cappuzzo F, Hilgers W, Romano G, Denis F, Viteri S, Debieuvre D, Galetta D, Baldini E, Razaq M, Robinet G, Maio M, Delmonte A, Roch B, Masson P, Schuette W, Zer A, Remon J, Costantini D, Vasseur B, Dziadziuszko R, Giaccone G; ATALANTE-1 study group. Randomized open-label controlled study of cancer vaccine OSE2101 versus chemotherapy in HLA-A2-positive patients with advanced non-small-cell lung cancer with resistance to immunotherapy: ATALANTE-1. Ann Oncol. 2023 Oct;34(10):920-933. doi: 10.1016/j.annonc.2023.07.006. Epub 2023 Sep 11.

    PubMed 37704166

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OSE2101, Docetaxel and Pemetrexed in people with Non Small Cell Lung Cancer, run by OSE Immunotherapeutics at 78 sites in 10 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 21 inclusion and 19 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 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in France, Italy, United States, Spain, Hungary and 5 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?

Yes. Results are posted in the registry (first posted 2 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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: Approx. 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02654587, which also lists 1 linked publication.

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 2 Feb 2024.

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