Trial document




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  DRKS00013939

Trial Description

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Title

PRedictability of Outcome based on iMmunological sIgnatureS in lung cancEr – an explorative investigation

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Trial Acronym

PROMISE

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URL of the Trial

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Brief Summary in Lay Language

During this study, it will be examined in patients with lung cancer (non small cell lung cancer, NSCLC) which mechanisms the immune system has developed so that cancer cells are not (anymore) recognized and destroyed by the body's own defense. This knowledge may be helpful that in the future it will not only be possible to predict if a tumour will respond to a treatment or not, but may be able to facilitate that the best treatment for the patient (chemotherapy, immuntherapy, so called "targeted therapies") is chosen.
For a detailed examination of the immune system the repeated analysis of so called immunological signatures (i.e. a combination of different markers in blood, stool, breath condensate and lung tissue) is necessary.

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Brief Summary in Scientific Language

Primary objective of this study is the exploration of immunological signatures in patients with non small cell lung cancer (NSCLC) which might allow prediction of the clinical response/non-response of an approved first-line and second-line treatment. Immonological signatures will be repeatedly assessed in blood, stool, breath condensate and lung tissue.

Relevant procotol Amendments:
December 2018: change of exclusion criterion No. 6, adaption of time regarding samples, reduction of routine visite intervals and the possibility to go to the local general practicioner in between, change in reasons for withdrawal, adaption of archiving period.

July 2019: Addition of 2 study specific visits (T2 extended and T3 extended) with the option to carry out additional biopsies/sampling e.g. in case of discordant response, change in wording for inclusion criterion No. 5 and No. 6 as well as exclusion criterion No. 3, change of the individual clinical study end to 24 months.

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Organizational Data

  •   DRKS00013939
  •   2018/03/22
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  •   yes
  •   Approved
  •   S-710/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Patients will NSCLC will be examined for immunological signatures.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

objective response rate, ORR;
progression free survival, PFS.
The primary endpoints will be determined until the individual clinical study end of the patient. The individuall clinical study end is reached within 24 months after start of therapy.

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Secondary Outcome

overall survival, OS.
The survival status will be determined up to 5 years after begin of the first line therapy.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/06/01
  •   150
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

1. Patients ≥ 18 years, no upper age limit
2. Ability of the participant to understand the nature and scope of the clinical trial as well as full capacity of consent
3. Written informed consent
4. By imaging suspected primary, not locally curative treatable lung carcinoma
5. Possibility of an additional biopsy of the primary tumour or a metastasis as part of routine diagnostics during screening and during the study in case of discordant response with local progression of single leasons and stability of the remaining leasons, as well as after progression under /intolerance of first-line therapy as well as optionally after progression under/intolerance of second-line therapy
6. Possibility of collection (as defined in the protocol) of blood, stool and breath condensate samples prior to start of treatment, 6 to max. 10 weeks after start of treatment (stool and breath condensate) , after progression under /intolerance of first-line therapy , after progression under/intolerance of second-line therapy, as well as during possible additional biopsies.
7. Consent for the collection of blood and tissue samples that exceed the routine diagnostic
8. Histological evidence of NSCLC
9. No previous systemic palliative treatment of the NSCLC
10. Performance status ECOG 0-1
11. Adequate organ function defined as :
• adequate hematological function (neutrophile granulocytes (absolute) ≥1000/µl, platelets≥100.000/µl, hemoglobin ≥8.5 g/dl [5.6 mmol/l] (possible after transfusion))
• adequate kidney function (serum creatinine ≤1.5 mg/dl [114.5 µmol/l] or estimated creatinine clearance calculated with the formula by Cockroft and Gault ≥30 ml/min)
• adequate liver function (serum bilirubine ≤2x ULN, AST/ALT ≤3x ULN, in case of liver metastasis AST/ALT ≤5x ULN)

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Exclusion Criteria

1. Patient is pregnant or lactating
2. Other simultaneous cancer treatments
3. HIV infection or active hepatitis B or C infection
4. Cardiovascular disease with
o myocardial infarction (T-wave/Non-T-wave) within the last 3 months
o unstable angina pectoris
o class III or IV heart failure as defined by the New York Heart Association (NYHA)
5. Any clinically relevant bleeding within 2 weeks prior to the first planned biopsy
6. Brain metastasis that are symptomatic or require immediate treatment. High degree of clinical suspicion is sufficient even without imaging.
7. Any medical condition of the patient that in the opinion of the investigator limits the ability of the patient to finish the study.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Nationales Centrum für Tumorerkrankungen (NCT)
    • Mr.  Prof. Dr. med.  Dirk  Jäger 
    • Im Neuenheimer Feld 460
    • 69120  Heidelberg
    • Germany
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    • Nationales Centrum für Tumorerkrankungen (NCT)
    • Mr.  Prof. Dr. med.  Dirk  Jäger 
    • Im Neuenheimer Feld 460
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum Heidelberg Thoraxklinik-Heidelberg gGmb
    • Mr.  PD Dr. med.  Tilmann  Bochtler 
    • Röntgenstraße 1
    • 69126  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Dietmar-Hopp-Stiftung gGmbH
    • 68789   St. Leon-Rot
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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