Non-small-cell Lung Cancer With Somatic EGFR Mutations Clinical Trial
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
This study aims to compare the efficacy of afatinib maintenance with pemetrexed maintenance following induction therapy with platinum/ pemetrexed in patients with metastatic epidermal growth factor receptor (EGFR) mutated non-small-cell lung cancer (NSCLC) progressing after first-line treatment with afatinib with respect to progression-free survival.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02595840 -
Biomarker Study Accompanying the AIO-TRK-0114 Study (MARBLE)
|
Phase 2 |