Skip to content

Phase II study of EGFR-TKI rechallenge with afatinib in advanced NSCLC patients haboring sensitive EGFR mutation without T790M

Phase II study of EGFR-TKI rechallenge with afatinib in advanced NSCLC patients haboring sensitive EGFR mutation without T790M - Phase II study of EGFR-TKI rechallenge with afatinib in advanced NSCLC patients haboring sensitive EGFR mutation without T790M

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015568
Enrollment
12
Registered
2014-11-30
Start date
2014-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

Sponsors

Okayama University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proven NSCLC 2)EGFR mutation (exon19 deletion or L858R in exon 21) without T790M proven by rebiopsy after PD of prior therapy 3)Age: over 20 4)PS(ECOG): 0-1 5)Unresectable clinical stage IIIB/IV 6)Previously treated with EGFR-TKI (only 1 regimen) and lasted for more than 6 months 7)Previously treated with plutinum combination chemotherapy 8)After 3rd line therapy 9)Interval of radiation therapy: 4 weeks after thoracic RT and 1 week after non-thoracic RT 10)Measurable disease for RECIST 11)Adequate organ functions judged by laboratory tests 12)Life expectancy: over 3 months 13)Written informed consent

Exclusion criteria

Exclusion criteria: 1)SCLC and sarcoma peoven by rebiopsy 2)Symptomatic brain metastases 3)Leptomeningeal carcinomatosis 4)Active double cancer 5)Severe allergic history 6)Pregnancy 7)Svere complication 8)Indicated for urgent RT 9)Allergic history for afatinib 10)Inadequate patients whom physitians considered

Design outcomes

Primary

MeasureTime frame
Progression free survival

Countries

Japan

Contacts

Public ContactNaohiro Oda

Okayama University Hospital Department of Respiratory Medicine

pgjj77o3@s.okayama-u.ac.jp086-223-7151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026