Maintaining ERBB Blockade in EGFR-mutated Lung Cancer (MARBLE)
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|ClinicalTrials.gov Identifier: NCT02488694|
Recruitment Status : Terminated (unsufficient recruitment)
First Posted : July 2, 2015
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Non-small-cell Lung Cancer With Somatic EGFR Mutations||Drug: Afatinib Drug: Pemetrexed||Phase 2|
This is a randomized, open-label, phase II study of maintaining pan-ERBB blockade following platinum-based induction chemotherapy in patients with EGFR mutated, metastatic NSCLC progressing after first-line treatment with afatinib.
Patients who have progressed after first-line treatment with afatinib will be screened while receiving an induction phase which consists of at least three but not more than four cycles 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 three or four cycles induction chemotherapy will then be randomized (1:1 ratio) to receive maintenance therapy with either afatinib (40 mg/d, or last dose if reduced during first-line treatment) or pemetrexed (500 mg/m² every 21 days, or 375 mg/m² if dose was reduced during induction therapy) until disease progression, unacceptable toxicity or patient consent withdrawal.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-label, Phase II Study of Maintaining Pan-ERBB Blockade Following Platinum-based Induction Chemotherapy in Patients With EGFR Mutated, Metastatic Non-small-cell Lung Cancer Progressing After Treatment With Afatinib as First EGFR-targeting Agent|
|Study Start Date :||November 2015|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Experimental: Arm A: Afatinib
105 patients to be treated with afatinib
Other Name: GIOTRIF®
Active Comparator: Arm B: Pemetrexed
105 patients to be treated with pemetrexed
500 mg/m² i.v. on d1 of each 21-day cycle
Other Name: ALIMTA®
- Progression-free survival [ Time Frame: 40 months ]The primary endpoint of this study is progression-free survival (RECIST 1.1).
- Overall survival [ Time Frame: 40 months ]Efficacy measure
- Objective response rate [ Time Frame: 40 months ]Objective response rate (ORR), clinical benefit rate (RECIST 1.1); Efficacy measure
- Quality of Life [ Time Frame: 40 month ]Health-Related Quality of Life (HRQoL)
- Safety (intensity and incidence of adverse events, graded according to US NCI CTCAE Version 4.03) [ Time Frame: 40 month ]Safety, toxicity (intensity and incidence of adverse events, graded according to US NCI CTCAE Version 4.03)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488694
|Principal Investigator:||Martin Schuler, Prof. Dr.||Westdeutsches Tumorzentrum, Universitätsklinikum Essen|