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

Sponsor
Universität Duisburg-Essen (Other)
Overall Status
Terminated
CT.gov ID
NCT02595840
Collaborator
(none)
4
Enrollment
2
Arms
23.9
Actual Duration (Months)

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A randomized, open-label, phase II studyA 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 :
Nov 25, 2015
Actual Primary Completion Date :
Nov 20, 2017
Actual Study Completion Date :
Nov 20, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Progression-free Survival in relation to exploratory biomarkers [until progression]

Secondary Outcome Measures

  1. Overall Survival in relation to exploratory biomarkers [continuous assessment]

    Overall survival

  2. Objective response rate [Assessed every 6 weeks for 24 weeks, then every 9 weeks]

    Objective response rate, clinical benefit rate (RECIST 1.1)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universität Duisburg-Essen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Martin Schuler, Prof. Dr. med., Director, Department of Medical Oncology, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT02595840
Other Study ID Numbers:
  • EudraCT-Nr. 2014-001983-36
First Posted:
Nov 4, 2015
Last Update Posted:
Apr 19, 2019
Last Verified:
Apr 1, 2019
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:
Carcinoma, Non-Small-Cell Lung
Pemetrexed
Afatinib

Study Results

No Results Posted as of Apr 19, 2019