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

Universität Duisburg-Essen

Status and phase: Terminated; Phase 2

Conditions: Non-small-cell Lung Cancer With Somatic EGFR Mutations

Treatments: Drug: Afatinib; Drug: Pemetrexed

Study type: Interventional

Funder types: Other

Identifiers

NCT02595840

EudraCT-Nr. 2014-001983-36

Details and patient eligibility

About

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

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Arm A: Afatinib

Experimental group

Description:

Afatinib 40 mg/d (30, or 20 mg/d in case of dose reduction during 1st line treatment)

Treatment:

Drug: Afatinib

Arm B: Pemetrexed

Experimental group

Description:

Pemetrexed 500 mg/m2 (375 mg/m² in case of dose reduction during induction therapy) i.v. on d1 of each 21-day cycle

Treatment:

Drug: Pemetrexed