Non-small-cell Lung Cancer With Somatic EGFR Mutations Clinical Trial
— Trans-MARBLEOfficial title:
Biomarker Study Accompanying the AIO-TRK-0114 Study (MARBLE)
Verified date | April 2019 |
Source | Universität Duisburg-Essen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Terminated |
Enrollment | 4 |
Est. completion date | November 20, 2017 |
Est. primary completion date | November 20, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Universität Duisburg-Essen |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free Survival in relation to exploratory biomarkers | until progression | ||
Secondary | Overall Survival in relation to exploratory biomarkers | Overall survival | continuous assessment | |
Secondary | Objective response rate | Objective response rate, clinical benefit rate (RECIST 1.1) | Assessed every 6 weeks for 24 weeks, then every 9 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02488694 -
Maintaining ERBB Blockade in EGFR-mutated Lung Cancer
|
Phase 2 |