Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003850

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003850
  •   2012/09/28
  •   2010/07/08
  •   no
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Secondary IDs

  •   NCT01159964  (ClinicalTrials.gov)
  •   113174  (GlaxoSmithKline)
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Health Condition or Problem studied

  •   Lung Cancer, Non-Small Cell
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Biological: Immunotherapeutic GSK2302032A, different formulations
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Treatment
  •   Parallel
  •   I
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Primary Outcome

- 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)
- Occurrence of dose-limiting toxicities during study follow-up; time frame: 12 months after concluding visit (week 112)
- Anti-PRAME humoral immune response; time frame: Assessed post-dose 4 (Week 12)
- Anti-PRAME humoral immune response; time frame: Throughout the study (Day 0 until 12 months after concluding visit (week 112))

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Secondary Outcome

- Occurrence of adverse events (AEs) and serious adverse events; time frame: During the whole study treatment period until 30 days after the last treatment administration.
- The anti-PRAME cellular (T-cell) response; time frame: At 6 defined time-points during the study (Week 0, 12, 24, 72 and 112) and follow-up period (6 months later).
- The anti-PRAME humoral immunogenicity; time frame: 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).

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Countries of Recruitment

  •   United States
  •   France
  •   Germany
  •   Italy
  •   Poland
  •   Russian Federation
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Locations of Recruitment

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Recruitment

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  •   2010/07/31
  •   45
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. 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.

2. 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.

3. Patient is >= 18 years of age at the time of signature of the first informed consent
form.

4. The patient's tumor shows expression of the PRAME gene.

5. 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.

6. 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.

7. ECOG performance status of 0, 1 or 2.

8. Adequate bone-marrow reserve, renal, adrenal and hepatic function as assessed by
standard laboratory criteria

9. 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.

10. 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.

11. In the view of the investigator, the patient can and will comply with the
requirements of the protocol.

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Exclusion Criteria

1. The primary tumor was removed by segmentectomy or wedge resection.

2. 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.

3. The patient requires concomitant treatment (more than 7 consecutive days) with
systemic corticosteroids or any other immunosuppressive agents.

4. 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.

5. 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.

6. History of allergic disease or reactions likely to be exacerbated by any component of
the study investigational product.

7. History of confirmed adrenal dysfunction.

8. 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.

9. The patient has received a major organ allograft.

10. The patient is known to be Human Immunodeficiency Virus (HIV) -positive.

11. The patient has an uncontrolled bleeding disorder.

12. 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.

13. The patient needs home oxygenation.

14. The patient has psychiatric or addictive disorders that may compromise his/her
ability to give informed consent, or to comply with the trial procedures.

15. 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.

16. For female patients: the patient is pregnant or lactating.

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Addresses

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    • GlaxoSmithKline
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  • start of 1:1-Block address scientific-contact
    • GlaxoSmithKline
    • GSK Clinical Trials 
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    • GlaxoSmithKline
    • GSK Clinical Trials 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   113
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.