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

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

— Trans-MARBLE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02595840
• Other study ID #: EudraCT-Nr. 2014-001983-36
• Status: Terminated
• Phase: Phase 2
• Start date: November 25, 2015
• Est. completion date: November 20, 2017

Study information

• Verified date: April 2019
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

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

Intervention

Drug:
• Afatinib

• Pemetrexed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Outcome

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