AzTrials
AzTrials

Non-Small-Cell Lung CarcinomaPhase 2/3TIMENCT01383148

Phase IIB/III Of TG4010 Immunotherapy In Patients With Stage IV Non-Small Cell Lung Cancer

A Phase 2/3 study testing TG4010 in people with Non-Small-Cell Lung Carcinoma, run by Transgene at 72 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

This is a Phase IIb/III randomized, double-blind, placebo-controlled study to compare the efficacy and safety of first-line therapy combined with TG4010 or placebo in stage IV non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small-Cell Lung Carcinoma
What is being tested?
TG4010
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
222 participants
Where
72 sitesin 10 countries
Study dates
Apr 2012to Jul 2016
Phase
Phase 2/3
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

  • Histologically confirmed NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
  • Stage IV cancer according to TNM classification (7th edition - UICC, December 2009; includes tumor with malignant pleural or pericardial effusion
  • Tumor biopsy specimen with ≥ 50% of MUC1 expressing tumor cells determined by Immunohistochemistry (IHC) staining on fixed pathological material. Biopsy may come either from the primary tumor or from a metastasis. Cytological material is not accepted for this analysis
  • Patient's naïve to first-line therapy for the advanced stage of the disease. Previous neoadjuvant or adjuvant therapy is allowed for patients who successfully underwent complete radical surgery and if last treatment was administered more than 12 months prior to the start of the study treatment, i.e., D1 of Cycle 1.
  • At least one measurable lesion by CT scan or MRI based on RECIST version 1.1
  • PS 0 or 1 on the ECOG scale
Show all 18Show fewer
  • Adequate hematological, hepatic, and renal function:
  • Hemoglobin ≥ 10.0 g/dL
  • White Blood Cells (WBC) ≥ 3.0x10E9/L including
  • Neutrophils ≥ 1.5x109/L
  • Total lymphocytes count ≥ 0.5x10E9/L
  • Platelets count ≥ 100x10E9/L
  • Serum alkaline phosphatase ≤ 3x ULN (upper limit of normal)in the absence of liver or bone metastases or ≤5 ULN(in patients with documented bone or liver metastases)
  • Serum transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) ≤ 2.5 x ULN in the absence of liver metastases or =< 5 ULN in case of liver metastases)
  • Total bilirubin ≤1.5 x ULN
  • Glomerular Filtration Rate ≥ 60 mL/min (according to Modification of the Diet in Renal Disease (MDRD) formula or cockroft \& Gault formula)
  • Serum albumin ≥ 30 g/L
  • Effective contraception during the study period and for 3 months after the last study treatment administration (male and female patient)

Who cannot join

  • Patients having Central Nervous System (CNS) metastases. Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed
  • Documented EGFR activating mutations (if already tested)
  • Prior history of other malignancy except:
  • Basal cell carcinoma of the skin
  • Cervical intra epithelial neoplasia
  • Other cancer curatively treated with no evidence of disease for at least 5 years
Show all 16Show fewer
  • Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (e.g., cyclosporine) for a period of at least 4 weeks and whose treatment was not stopped 1 week prior to the start of the study treatment (i.e., D1 of Cycle 1)
  • Positive serology for Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV); presence in the serum of the antigens HBs
  • Patient with any underlying medical condition that the treating physician considers might be aggravated by treatment or which is not controlled (e.g., elevated troponin or creatinine, uncontrolled diabetes)
  • Patient with major surgery or radiotherapy within 4 weeks prior to the start of the study treatment (i.e., D1 of Cycle 1). Prior surgery or radiation therapy aimed at local palliation or attempted local disease control is permitted
  • Patient with an organ allograft
  • Known allergy to eggs, gentamicin or platinum-containing compounds
  • Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment (i.e., D1 of Cycle 1)
  • Patient unable or unwilling to comply with the protocol requirements
  • Pregnancy or lactation
  • Bevacizumab will be allowed for patients with non-squamous carcinoma. Prescribing information must be followed and precautions have to be taken into consideration (e.g., patients having presented a serious hemorrhage or recent hemoptysis should not receive bevacizumab).

Trial locations and contacts

72 sites in 10 countries.

72 sites in 10 countries

France16 sites

  • CHU, Service de Pneumologie

    Besançon, 25000

  • Centre François Baclesse

    Caen, 14076

  • CHU de Clermont-Ferrand, Hopital Gabriel Montpied

    Clermont-Ferrand, 63000

  • Hôpital Pasteur - Service de médecine F- Pavillon 43

    Colmar, 68000

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94010

  • CHRU de Lille Hopital Calmette

    Lille, 59037

  • Clinique François Chénieux

    Limoges, 87039

  • Institut Paoli-Calmettes, Service d'oncologie médicale

    Marseille, 13273

  • CH Mulhouse Hopital Emile Muller Moenchsberg

    Mulhouse, 68070

  • Hopital Saint Joseph

    Paris, 75014

  • Hôpital Pontchaillou

    Rennes, 35033

  • CHU de Saint-Etienne, Hôpital Nord

    Saint-Etienne, 42055

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42270

  • Centre Médical Alfred Leune

    Sainte-Feyre, 23000

  • Nouvel Hôpital Civil

    Strasbourg, 67000

  • Centre Hospitalier Intercommunal de la Haute Saone

    Vesoul, 70014

Other trials in France

United States12 sites

  • Texas Oncology, P.A. - Abilene (South)

    Abilene, Texas, 79606

  • Massachusetts General Hospital

    Cambridge, Maryland, 2114

  • Mary Crowley Medical Research Center

    Dallas, Texas, 75246

  • Highlands Oncology Group

    Fayetteville, North Carolina, 72703

  • University of Louisville Hospital

    Louisville, Kentucky, 40402

  • Signal Point Clinical Research Center

    Middletown, Ohio, 45042

  • Oncology/Hematology P.C.

    Rockville, Maryland, 20850

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Washington University

    St Louis, Missouri, 63110

  • ProMedica Health System Inc

    Toledo, Ohio, 43606

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Abington Hematology Oncology Associates Inc

    Willow Grove, Pennsylvania, 19090

Other trials in United States

Hungary12 sites

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Semmelweis Egyetem AOK

    Budapest, 1125

  • Orszagos Koranyi TBC es Pulmonologiai Intezet

    Budapest, 1525

  • Kenezy Korhaz-Rendelointezet Eu Szolgaltato Nonprofit Kft

    Debrecen, 4032

  • Petz Aladár Megyei Oktató kórház

    Győr, 9024

  • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza

    Gyula, 5703

  • Matrai Gyogyintezet

    Mátraháza, 3233

  • Fejér Megyei Szent György Kórház

    Székesfehérvár, 8000

  • Tolna Megyei Onkormanyzat Balassa Janos Korhaza

    Szekszárd, 7100

  • Komarom-Esztergom Megyei Onkorm. Szent Borbala Korhaza

    Tatabánya, 2800

  • Tudogyogyintezet Torokbalint

    Törökbálint, 2045

  • Zala Megyei Korhaz

    Zalaegerszeg, 8900

Other trials in Hungary

Israel7 sites

  • Assaf Harofeh Medical Center

    Beer Yaacov, 70300

  • Hadassah Ein Kerem Medical Center

    Jerusalem, 91120

  • Sapir Medical Center Meir Hospital

    Kfar Saba, 52621

  • Rabin Medical Center-Beilinson Campus

    Petah Tikva, 49372

  • Chaim Sheba Medical Center

    Ramat Gan, 44281

  • Kaplan Medical Center

    Rehovot, 76100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Spain7 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • ICO Girona - Hospital Dr Josep Trueta

    Girona, 17007

  • Hospital Gregorio Marañon

    Madrid, 28007

  • START Madrid. Centro Integral Oncologico Clara Campal

    Madrid, 28050

  • Hospital General Carlos Haya

    Málaga, 29010

  • Corporació Sanitària Parc Taulí

    Sabadell, 08208

Other trials in Spain

Poland5 sites

  • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin, 20-954

  • SP Zespol Gruzlicy i Chorob Pluc w Olsztynie

    Olsztyn, 10-357

  • Mazowieckie Centrum Leczenia Chorob Pluc i Gruzlicy

    Otwock, 05-400

  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

    Poznan, 60569

  • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

    Warsaw, 02-781

Other trials in Poland

Belgium4 sites

  • ZNA Middelheim

    Antwerp, 2020

  • Clinique Nôtre-Dame de Grâce

    Gosselies, 6041

  • Centre Hospitalier de l'Ardenne

    Libramont, 6800

  • C. H. U. Sart-Tilman

    Liège, 4000

Other trials in Belgium

United Kingdom4 sites

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • Velindre Hospital NHS Trust

    Cardiff, CF14 2TL

  • Plymouth Oncology Centre

    Plymouth, PL6 8DH

  • Southampton University Hospitals NHS Trust

    Southampton, SO16 6YD

Other trials in United Kingdom

Italy3 sites

  • IEO Istituto Europeo di Oncologia

    Milan, 20141

  • Azienda Ospedaliera di Perugia Ospedale S.Maria della Miseri

    Perugia, 6156

  • A.O.U. Senese Policlinico Santa Maria alle Scotte

    Siena, 53100

Other trials in Italy

Germany2 sites

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitaetsklinikum Mannheim

    Mannheim, 68167

Other trials in Germany

About this study

Official title: A Phase IIB/III Randomized, Double-blind, Placebo Controlled Study Comparing First Line Therapy With or Without TG4010 Immunotherapy Product in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

This is a Phase IIb/III randomized, double-blind, placebo-controlled study to compare the efficacy and safety of first-line therapy combined with TG4010 or placebo in stage IV non-small cell lung cancer (NSCLC).

TG4010 is a suspension of recombinant Modified Vaccinia virus strain Ankara (MVA strain) carrying coding sequences for human MUC1 antigen and human interleukin-2 (IL2). TG4010 has been developed for use as an immunotherapy in cancer patients whose tumors express the MUC1 antigen.

TG4010 is intended to induce a MUC1-specific cellular immune response and to produce a non-specific activation of several components of the immune system.

Being tested
TG4010, placebo
Keywords
NSCLC
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.

  • TG4010Biological

    TG4010 • TG4010 will be administered starting on Day 1 (D1) of Cycle 1 of chemotherapy and will be administered weekly for 6 weeks by subcutaneous (SC) injections and then once every 3 weeks until progression or discontinuation due to any reason.

    Chemotherapy (and bevacizumab if prescribed), will be given as 21-day cycles for a minimum of 4 cycles and up to 6 cycles.

    First line therapy:

    • Non-squamous carcinoma: pemetrexed + cisplatin or paclitaxel + carboplatin +/- bevacizumab
    • Squamous carcinoma: gemcitabine + cisplatin or paclitaxel + carboplatin

    Maintenance therapy:

    • Pemetrexed or erlotinib for eligible patients and according to labeling.

  • placeboDrug

    Also called paclitaxel, carboplatin, pemetrexed, cisplatin

    Placebo will be administered starting on D1 of Cycle 1 of chemotherapy and will be administered weekly for 6 weeks by SC injections and then once every 3 weeks until progression or discontinuation due to any reason.

    • First line therapy: as in Arm 1
    • Maintenance therapy: as in Arm 1
Study groups in NCT01383148
Study groupRoleWhat they receive
Arm 1 - TG4010 + first line therapyExperimentalFirst-line therapy and maintenance therapy
Receives: Biological: TG4010
Arm 2 : Placebo + first line therapyActive comparatorFirst-line therapy and maintenance therapy
Receives: Drug: placebo

What is being measured

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

  1. Phase 2: Progression-free Survival (PFS)

    PFS is measured from date of randomization to radiographically documented progression according to RECIST 1.1 or death from any cause (whichever occurs first). Participants alive and without disease progression or lost to follow-up will be censored at the date of their last radiographic assessment.

    Measured: Approximately 15 months

  2. Phase 3: Overall Survival (OS)

    OS is measured from date of randomization to date of death from any cause.

    Measured: Approximately 27 months

Secondary outcomes (8)

  1. Phase 2 : Overall Survival (OS)

    Measured: Approximately 15 months

  2. Phase 2 : Overall Response Rate (ORR)

    Measured: Approximately 15 months

  3. Phase 3: Progression-free Survival (PFS)

    Measured: Approximately 27 months

  4. Phase 3 : Overall Response Rate (ORR)

    Measured: Approximately 27 months

  5. Phase 2 : Duration of response

    Measured: Approximately 15 months

  6. Phase 2: Safety

    Measured: Approximately 15 months

  7. Phase 3: Duration of response

    Measured: Approximately 27 months

  8. Phase 3: Safety

    Measured: Approximately 27 months

Timeline

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

  1. First posted28 Jun 2011 (estimated)
  2. Study startApr 2012
  3. Primary completionJul 2015
  4. Study completionJul 2016

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01383148
Sponsor's protocol ID
TG4010.14/TIME
Other IDs
8559
Acronym
TIME
Status last verified
Jan 2017
First submitted
23 Jun 2011
Last updated
5 Jan 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Tosch C, Bastien B, Barraud L, Grellier B, Nourtier V, Gantzer M, Limacher JM, Quemeneur E, Bendjama K, Preville X. Viral based vaccine TG4010 induces broadening of specific immune response and improves outcome in advanced NSCLC. J Immunother Cancer. 2017 Sep 19;5(1):70. doi: 10.1186/s40425-017-0274-x.

    PubMed 28923084

  • Quoix E, Lena H, Losonczy G, Forget F, Chouaid C, Papai Z, Gervais R, Ottensmeier C, Szczesna A, Kazarnowicz A, Beck JT, Westeel V, Felip E, Debieuvre D, Madroszyk A, Adam J, Lacoste G, Tavernaro A, Bastien B, Halluard C, Palanche T, Limacher JM. TG4010 immunotherapy and first-line chemotherapy for advanced non-small-cell lung cancer (TIME): results from the phase 2b part of a randomised, double-blind, placebo-controlled, phase 2b/3 trial. Lancet Oncol. 2016 Feb;17(2):212-223. doi: 10.1016/S1470-2045(15)00483-0. Epub 2015 Dec 23.

    PubMed 26727163

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing TG4010 in people with Non-Small-Cell Lung Carcinoma, run by Transgene at 72 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 18 inclusion and 16 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 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in France, United States, Hungary, Israel, Spain 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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. 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?

Phase 2: Progression-free Survival (PFS) (time frame: Approximately 15 months). The study lists 2 primary outcomes in all. 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 NCT01383148, which also lists 2 linked publications.

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 5 Jan 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in