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Lung Cancer, Non-Small CellPhase 1NCT01159964

Evaluation of a New Anti-cancer Vaccine for Patients With Non-small Cell Lung Cancer, After Tumor Removal by Surgery

A Phase 1 study testing Immunotherapeutic GSK2302032A, different formulations in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 37 sites in 6 countries.

Terminated

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

Official record
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Trial summary

The purpose of this clinical study is to assess the safety and immunogenicity of the immunotherapeutic product GSK 2302032A when given to Non-Small Cell Lung Cancer (NSCLC) patients, after tumor removal by surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Non-Small Cell
What is being tested?
Immunotherapeutic GSK2302032A, different formulations
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
37 sitesin 6 countries
Study dates
20 Jul 2010to 10 Sep 2014
Phase
Phase 1
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

  • Male or female patient with completely resected (R0 resection), pathologically proven stage IB, II or IIIA NSCLC. Patients are allowed to receive adjuvant platinum-based chemotherapy for the treatment of the current NSCLC between surgery and enrolment.
  • Written informed consent for PRAME gene expression screening on resected tumor tissue has been obtained from the patient prior to shipment of the sample for expression testing, and written informed consent for the complete study participation has been obtained before the performance of any other protocol specific procedure.
  • Patient is >= 18 years of age at the time of signature of the first informed consent form.
  • The patient's tumor shows expression of the PRAME gene.
  • The surgical technique for resection of the patient's tumor is anatomical, involving at least a lobectomy or a sleeve lobectomy. The first ASCI administration will be given, either within 12 weeks after surgery or within 8 weeks after day 1 of last chemotherapy cycle and within 32 weeks after resection.
  • The patient is free of metastasis, as confirmed by a negative baseline computer tomogram (CT scan) of the chest and upper abdomen as well as CT scan or magnetic resonance imaging (MRI) of the brain. These tests are to be performed within 6 weeks for the CT scan of the chest and upper abdomen and within 12 weeks for the brain CT scan or MRI before first ASCI administration.
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  • ECOG performance status of 0, 1 or 2.
  • Adequate bone-marrow reserve, renal, adrenal and hepatic function as assessed by standard laboratory criteria
  • Female patients of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as current tubal-ligation, hysterectomy, ovariectomy or post-menopause.
  • Female patient of childbearing potential may be enrolled in the study, if the patient:
  • has practiced adequate contraception for 30 days prior to study product administration, and
  • has a negative pregnancy test on the day of administration, and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study product administration series.
  • In the view of the investigator, the patient can and will comply with the requirements of the protocol.

Who cannot join

  • The primary tumor was removed by segmentectomy or wedge resection.
  • The patient has received any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy or neo-adjuvant chemotherapy, except for the treatment of previous malignancies allowed by the protocol.
  • The patient requires concomitant treatment (more than 7 consecutive days) with systemic corticosteroids or any other immunosuppressive agents.
  • Use of any investigational or non-registered product (drug or vaccine, except influenza vaccine in the context of H1N1 mass-vaccination) other than the study product within the 30 days preceding the first dose of study product, or planned use during the study period.
  • The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for more than 3 years and highly likely to have been cured.
  • History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
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  • History of confirmed adrenal dysfunction.
  • The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
  • The patient has received a major organ allograft.
  • The patient is known to be Human Immunodeficiency Virus (HIV) -positive.
  • The patient has an uncontrolled bleeding disorder.
  • The patient has uncontrolled congestive heart failure or uncontrolled hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrolment.
  • The patient needs home oxygenation.
  • The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
  • The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
  • For female patients: the patient is pregnant or lactating.

Trial locations and contacts

37 sites in 6 countries.

37 sites in 6 countries

Germany11 sites

  • GSK Investigational Site

    Berlin, 13125

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 51109

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69126

  • GSK Investigational Site

    Immenhausen, Hesse, 34376

  • GSK Investigational Site

    Leipzig, Saxony, 04129

  • GSK Investigational Site

    Moers, North Rhine-Westphalia, 47441

  • GSK Investigational Site

    Munich, Bavaria, 81925

  • GSK Investigational Site

    Regensburg, Bavaria, 93049

  • GSK Investigational Site

    Regensburg, Bavaria, 93053

  • GSK Investigational Site

    Velbert, North Rhine-Westphalia, 42551

Other trials in Germany

United States7 sites

  • GSK Investigational Site

    Boston, Massachusetts, 02114

  • GSK Investigational Site

    Everett, Washington, 98201

  • GSK Investigational Site

    New York, New York, 10021

  • GSK Investigational Site

    Newark, Delaware, 19713

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104

  • GSK Investigational Site

    Rochester, Minnesota, 55905

  • GSK Investigational Site

    Seattle, Washington, 98104

Other trials in United States

Italy5 sites

  • GSK Investigational Site

    Meldola (FC), Emilia-Romagna, 47014

  • GSK Investigational Site

    Milan, Lombardy, 20141

  • GSK Investigational Site

    Perugia, Umbria, 06156

  • GSK Investigational Site

    Pisa, Tuscany, 56100

  • GSK Investigational Site

    Rome, Lazio, 00152

Other trials in Italy

Poland5 sites

  • GSK Investigational Site

    Chęciny, 26-060

  • GSK Investigational Site

    Lublin, 20-954

  • GSK Investigational Site

    Szczecin, 70-891

  • GSK Investigational Site

    Warsaw, 04-125

  • GSK Investigational Site

    Zakopane, 34-500

Other trials in Poland

Russia5 sites

  • GSK Investigational Site

    Chelyabinsk, 454087

  • GSK Investigational Site

    Kazan', 420029

  • GSK Investigational Site

    Moscow, 115478

  • GSK Investigational Site

    Saint Petersburg, 197022

  • GSK Investigational Site

    Saint Petersburg, 197758

Other trials in Russia

France4 sites

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Nice, 06002

  • GSK Investigational Site

    Paris, 75571

  • GSK Investigational Site

    Toulouse, 31052

Other trials in France

About this study

Official title: Study of GSK2302032A Antigen-Specific Cancer Immunotherapeutic in Patients With Resectable Non-Small Cell Lung Cancer

The purpose of this clinical study is to assess the safety and immunogenicity of the immunotherapeutic product GSK 2302032A when given to Non-Small Cell Lung Cancer (NSCLC) patients, after tumor removal by surgery.

Being tested
Immunotherapeutic GSK2302032A, different formulations
Keywords
Antigen-Specific Cancer Immunotherapeutic (ASCI), PRAME, PRAME-positive stage IB, II or IIIA Non-Small Cell Lung Cancer patients after complete surgical resection, Non-Small Cell Lung Cancer
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.

  • Immunotherapeutic GSK2302032A, different formulationsBiological

    Also called PRAME ASCI

    Intramuscular administration

Study groups in NCT01159964
Study groupRoleWhat they receive
Cohort 1ExperimentalSubjects will receive investigational dose-level A (different from dose-levels B and C). All patients are to receive 13 injections of the immunotherapeutic GSK2302032A
Receives: Biological: Immunotherapeutic GSK2302032A, different formulations
Cohort 2ExperimentalSubjects will receive investigational dose-level B (different from dose-levels A and C). All patients are to receive 13 injections of the immunotherapeutic GSK2302032A
Receives: Biological: Immunotherapeutic GSK2302032A, different formulations
Cohort 3ExperimentalSubjects will receive investigational dose-level C (different from dose-levels A and B). All patients are to receive 13 injections of the immunotherapeutic GSK2302032A
Receives: Biological: Immunotherapeutic GSK2302032A, different formulations

What is being measured

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

  1. Occurrence of dose-limiting toxicities during study treatment

    Measured: During the study treatment period (up to 112 weeks, approximately 2 years and 2 months)

  2. Occurrence of dose-limiting toxicities during study follow-up

    Measured: 12 months after concluding visit (week 112)

  3. Anti-PRAME humoral immune response

    Measured: Assessed post-dose 4 (Week 12)

  4. Anti-PRAME humoral immune response

    Measured: Throughout the study (Day 0 until 12 months after concluding visit (week 112))

Secondary outcomes (3)

  1. Occurrence of adverse events (AEs) and serious adverse events

    Measured: During the whole study treatment period until 30 days after the last treatment administration.

  2. The anti-PRAME cellular (T-cell) response

    Measured: At 6 defined time-points during the study (Week 0, 12, 24, 72 and 112) and follow-up period (6 months later).

  3. The anti-PRAME humoral immunogenicity

    Measured: At 10 defined timepoints during the study (Week 0, 6, 12, 24, 48, 72, 96, 112), and follow-up period (6 and 12 months later).

Timeline

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

  1. First posted12 Jul 2010 (estimated)
  2. Study start20 Jul 2010
  3. Primary completion19 Oct 2011
  4. Study completion10 Sep 2014

Why it stopped: Study termination due to negative Phase III of another study product from same technology platform.

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01159964
Sponsor's protocol ID
113174
Status last verified
Jun 2018
First submitted
8 Jul 2010
Last updated
18 Jun 2018
Results posted
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Pujol JL, De Pas T, Rittmeyer A, Vallieres E, Kubisa B, Levchenko E, Wiesemann S, Masters GA, Shen R, Tjulandin SA, Hofmann HS, Vanhoutte N, Salaun B, Debois M, Jarnjak S, De Sousa Alves PM, Louahed J, Brichard VG, Lehmann FF. Safety and Immunogenicity of the PRAME Cancer Immunotherapeutic in Patients with Resected Non-Small Cell Lung Cancer: A Phase I Dose Escalation Study. J Thorac Oncol. 2016 Dec;11(12):2208-2217. doi: 10.1016/j.jtho.2016.08.120. Epub 2016 Aug 17.

    PubMed 27544054

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Immunotherapeutic GSK2302032A, different formulations in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 37 sites in 6 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 14 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 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Germany, United States, Italy, Poland, Russia and 1 more country. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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: Study termination due to negative Phase III of another study product from same technology platform.). 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?

Occurrence of dose-limiting toxicities during study treatment (time frame: During the study treatment period (up to 112 weeks, approximately 2 years and 2 months)). The study lists 4 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 NCT01159964, 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 18 Jun 2018.

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