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

Non-small-cell Lung Cancer With Somatic EGFR Mutations Clinical Trial

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

Status Terminated

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small-cell Lung Cancer With Somatic EGFR Mutations

• NCT number: NCT02595840
• Study type: Interventional
• Source: Universität Duisburg-Essen
• Status: Terminated
• Phase: Phase 2
• Start date: November 25, 2015
• Completion date: November 20, 2017