NCT02595840

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Universität Duisburg-Essen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small-cell Lung Cancer With Somatic EGFR Mutations

Interventions

Type	Name	Description
DRUG	Afatinib
DRUG	Pemetrexed

Timeline

• Start date: 2015-11-25
• Primary completion: 2017-11-20
• Completion: 2017-11-20
• First posted: 2015-11-04
• Last updated: 2019-04-19