NCT02595840

Brief 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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2015

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 4, 2015

Completed
21 days until next milestone

Study Start

First participant enrolled

November 25, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2017

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

October 23, 2015

Last Update Submit

April 18, 2019

Conditions

Non-small-cell Lung Cancer With Somatic EGFR Mutations

Outcome Measures

Primary Outcomes (1)

  • Progression-free Survival in relation to exploratory biomarkers

    until progression

Secondary Outcomes (2)

  • Overall Survival in relation to exploratory biomarkers

    continuous assessment

  • Objective response rate

    Assessed every 6 weeks for 24 weeks, then every 9 weeks

Study Arms (2)

Arm A: Afatinib

EXPERIMENTAL

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

Drug: Afatinib

Arm B: Pemetrexed

EXPERIMENTAL

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

Drug: Pemetrexed

Interventions

AfatinibDRUG
Arm A: Afatinib
PemetrexedDRUG
Arm B: Pemetrexed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participation in the AIO-TRK-0114 (MARBLE) study (EudraCT-No. 2014-001983-36)
  • Written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

AfatinibPemetrexed

Intervention Hierarchy (Ancestors)

AmidesOrganic ChemicalsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGuanineHypoxanthinesPurinonesPurinesGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, Dicarboxylic

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized, open-label, phase II study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Medical Oncology

Study Record Dates

First Submitted

October 23, 2015

First Posted

November 4, 2015

Study Start

November 25, 2015

Primary Completion

November 20, 2017

Study Completion

November 20, 2017

Last Updated

April 19, 2019

Record last verified: 2019-04