Phase II study of low-dose afatinib for elderly NSCLC patients

JRCT ID: jRCTs041180055

Registered date:27/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Non-small cell lung cancer
• Date of first enrollment: 04/08/2016
• Target sample size: 25
• Study type: Interventional

Intervention(s)

1) Treatment with afatinib at a dose of 20 mg daily (until PD).
2) At day 7-14 after the start of afatinib, samples for pharmacokinetc analyses will be obtained (9 points).
3) Afatinib were permitted to dose escalate, if patients did not experience Gr 1 diarrhea and Gr 1 anorexia with trough concentration of afatinib < 15 ng/mL at day 7-14.

Outcome(s)

• Primary Outcome: Progression-free survival
• Secondary Outcome: Response rate, Overall survival, Incidence of adverse events, PK analysis

Key inclusion & exclusion criteria

• Age minimum: >= 75age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Pathologically confirmation of non-small cell lung cancer
2) Clinical stage IIIB, IV, or postoperative recurrence
3) With activating EGFR mutation (Deletion in exon 19 or L858R in exon 21)
4) ECOG performance status 0-2
5) No prior therapy of EGFR-TKI
6) Measurable lesions based on RECIST ver1.1
7) Adequate organ functions
8) Written informed consent

Exclude criteria

1) Interstitial lung disease
2) Receiving continuous systemic corticosteroid
3) During pregnancy or lactation
4) Psychological disorder difficult to participate in this clinical study

Related Information

• Primary Sponsor: Takahashi Toshiaki
• Secondary ID(s): UMIN000022252