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

Phase 2

Terminated

• Conditions: Non-small-cell Lung Cancer With Somatic EGFR Mutations
• Interventions: Drug: Afatinib; Drug: Pemetrexed

• Registration Number: NCT02595840
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-04
• Study Start: 2015-11-25
• Primary Completion: 2017-11-20
• Study Completion: 2017-11-20
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-18
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Progression-free Survival in relation to exploratory biomarkers	until progression

Secondary Outcome Measures

Name	Time	Method
Objective response rate	Assessed every 6 weeks for 24 weeks, then every 9 weeks	Objective response rate, clinical benefit rate (RECIST 1.1)
Overall Survival in relation to exploratory biomarkers	continuous assessment	Overall survival