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Biomarker Study Accompanying the AIO-TRK-0114 Study (MARBLE) (Trans-MARBLE)

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ClinicalTrials.gov Identifier: NCT02595840
Recruitment Status : Terminated (Futility)
First Posted : November 4, 2015
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Martin Schuler, Prof. Dr. med., Universität Duisburg-Essen

Tracking Information
First Submitted Date  ICMJE October 23, 2015
First Posted Date  ICMJE November 4, 2015
Last Update Posted Date April 19, 2019
Actual Study Start Date  ICMJE November 25, 2015
Actual Primary Completion Date November 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
Progression-free Survival in relation to exploratory biomarkers [ Time Frame: until progression ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Overall Survival in relation to exploratory biomarkers [ Time Frame: continuous assessment ]
    Overall survival
  • Objective response rate [ Time Frame: Assessed every 6 weeks for 24 weeks, then every 9 weeks ]
    Objective response rate, clinical benefit rate (RECIST 1.1)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biomarker Study Accompanying the AIO-TRK-0114 Study (MARBLE)
Official Title  ICMJE Biomarker Study Accompanying the AIO-TRK-0114 Study (MARBLE)
Brief Summary To compare the efficacy of afatinib maintenance with pemetrexed maintenance following induction therapy with platinum/ pemetrexed in patients with metastatic EGFR mutated non-small-cell lung cancer progressing after first-line treatment with afatinib as first tyrosine kinase inhibitor with respect to progression-free survival
Detailed Description Patients who have progressed after first-line treatment with afatinib as first tyrosine kinase inhibitor (TKI) will be screened while they are receiving second-line (induction) treatment consisting of cisplatin / carboplatin plus pemetrexed given in 21-day cycles. Patients who do not progress (i.e. complete or partial response, or stable disease - CR, PR or SD) after completion of at least three and not more than four chemotherapy cycles will be randomized (1:1 ratio) to receive maintenance therapy with either afatinib (40 mg/d or last tolerated dose during first-line treatment with afatinib as first TKI) or pemetrexed (500 mg/m2 or 375 mg/m2 if dose reduction was required every 21 days) until disease progression or treatment discontinuation because of patient decision or toxicity.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A randomized, open-label, phase II study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small-cell Lung Cancer With Somatic EGFR Mutations
Intervention  ICMJE
  • Drug: Afatinib
  • Drug: Pemetrexed
Study Arms  ICMJE
  • Experimental: Arm A: Afatinib
    Afatinib 40 mg/d (30, or 20 mg/d in case of dose reduction during 1st line treatment)
    Intervention: Drug: Afatinib
  • Experimental: Arm B: Pemetrexed
    Pemetrexed 500 mg/m2 (375 mg/m² in case of dose reduction during induction therapy) i.v. on d1 of each 21-day cycle
    Intervention: Drug: Pemetrexed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 18, 2019)
4
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 20, 2017
Actual Primary Completion Date November 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participation in the AIO-TRK-0114 (MARBLE) study (EudraCT-No. 2014-001983-36)
  2. Written informed consent

Exclusion Criteria:

1. Patients who do not meet the inclusion criterial of the AIO-TRK-0114 (MARBLE) study (EudraCT-No. 2014-001983-36)

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02595840
Other Study ID Numbers  ICMJE EudraCT-Nr. 2014-001983-36
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martin Schuler, Prof. Dr. med., Universität Duisburg-Essen
Study Sponsor  ICMJE Universität Duisburg-Essen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universität Duisburg-Essen
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP