Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT02488694
Brief Summary:
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.
Detailed Description:
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:
NCT02488694
Study Brief:
Protocol Section:
NCT02488694