Biomarker Study Accompanying the AIO-TRK-0114 Study (MARBLE) | NCT02595840

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

NCT02595840

Sponsor

Universität Duisburg-Essen

Status

Terminated

Last Update Posted

Apr 19, 2019Actual

Enrollment

4Actual

Phase

Phase 2

Conditions

Non-small-cell Lung Cancer With Somatic EGFR Mutations

Interventions

Afatinib
Pemetrexed

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Futility

Expanded Access Info

Start Date

Nov 25, 2015Actual

Primary Completion Date

Nov 20, 2017Actual

Completion Date

Nov 20, 2017Actual

First Submitted Date

Oct 23, 2015

First Submission Date that Met QC Criteria

Nov 2, 2015

First Posted Date

Nov 4, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2019

Last Update Posted Date

Apr 19, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Martin Schuler, Prof. Dr. med., Director, Department of Medical Oncology, Universität Duisburg-EssenPrincipal Investigator

Lead Sponsor

Universität Duisburg-EssenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Afatinib	Drug		Arm A: Afatinib
Pemetrexed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival in relation to exploratory biomarkers		until progression

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival in relation to exploratory biomarkers	Overall survival	continuous assessment
Objective response rate	Objective response rate, clinical benefit rate (RECIST 1.1)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participation in the AIO-TRK-0114 (MARBLE) study (EudraCT-No. 2014-001983-36)
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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077716	Afatinib
D000068437	Pemetrexed

Ancestor Terms

ID	Term
D000577	Amides
D009930	Organic Chemicals
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring

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