Phase II study of DFP-14323 with low dose EGFR-TKI for EGFR mutation positive NSCLC.

Phase II study of DFP-14323 with low dose EGFR-TKI for EGFR mutation positive NSCLC. - Phase II study of DFP-14323

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000033062

Enrollment

Registered

2018-06-20

Start date

2018-06-20

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

NSCLC

Interventions

DFP-14323 Afatinib20mg 72weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with 1) Histological NSCLC 2) Stage III/IV 3) exon19 del/ exon21 L858R 4) Measurable lesions 5) First line chemo 6) Normal major organ's function 7) PS0-2 8) Life Expectancy 3M 9) Age 20-84 10) Capable of treatment with oral medicine 11) ECG within 4w 12) IC

Exclusion criteria

Exclusion criteria: Patients without 1) Contraindicated cases for Erlotinib or Afatinib or Osimertinib 2) Obvious infections 3) T790M, exon20 ins 4) Severe heart diseases 5) Severe complications 6) Brain metasitases 7) Severe digestive diseases 8) Severe thromboembolisms 9) Severe diarrhea 10) Severe psychosis

Design outcomes

Primary

Measure	Time frame
Disease Control Rate(DCR)	—

Secondary

Measure	Time frame
Efficacy 1)Objective Response Rate 2)Nuetrophil/Lymphocyte Rate 3)Tumor Maker Safety Rate of AE and SE	—

Countries

Japan

Contacts

Public ContactTsuneo Suzuki

Delta-Fly Pharma, Inc. Domestic R&D

tsuzuki1206@delta-flypharma.co.jp03-6231-1278

Outcome results

None listed

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