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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02595840
Recruitment Status : Terminated (Futility)
First Posted : November 4, 2015
Last Update Posted : April 19, 2019
Information provided by (Responsible Party):
Martin Schuler, Prof. Dr. med., Universität Duisburg-Essen

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

Condition or disease Intervention/treatment Phase
Non-small-cell Lung Cancer With Somatic EGFR Mutations Drug: Afatinib Drug: Pemetrexed Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, open-label, phase II study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biomarker Study Accompanying the AIO-TRK-0114 Study (MARBLE)
Actual Study Start Date : November 25, 2015
Actual Primary Completion Date : November 20, 2017
Actual Study Completion Date : November 20, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm A: Afatinib
Afatinib 40 mg/d (30, or 20 mg/d in case of dose reduction during 1st line treatment)
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
Drug: Pemetrexed

Primary Outcome Measures :
  1. Progression-free Survival in relation to exploratory biomarkers [ Time Frame: until progression ]

Secondary Outcome Measures :
  1. Overall Survival in relation to exploratory biomarkers [ Time Frame: continuous assessment ]
    Overall survival

  2. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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Responsible Party: Martin Schuler, Prof. Dr. med., Director, Department of Medical Oncology, Universität Duisburg-Essen Identifier: NCT02595840    
Other Study ID Numbers: EudraCT-Nr. 2014-001983-36
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019

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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
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors