Clinical trial · Interventional

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

NCT02595840CI-TRIAL-00038258Trans-MARBLEterminatedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Futility

Summary

Brief summary (as posted)

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

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Non-small-cell Lung Cancer With Somatic EGFR Mutations	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Afatinib	Drug	Afatinib	ALIAS
Pemetrexed	Drug	Pemetrexed	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Arm A: Afatinib
description
Afatinib 40 mg/d (30, or 20 mg/d in case of dose reduction during 1st line treatment)
interventionNames
1. Drug: Afatinib
type
EXPERIMENTAL
label
Arm B: Pemetrexed
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
interventionNames
1. Drug: Pemetrexed

Primary outcomes (1)

measure
Progression-free Survival in relation to exploratory biomarkers
timeFrame
until progression

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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)

References

Publications (0)

Data not yet available

No reference posted for this study.