A phase II, biomarker study using digital PCR method in EGFR mutated, advanced lung adenocarcinoma patients treated with afatinib. WJOG8114LTR

A phase II, biomarker study using digital PCR method in EGFR mutated, advanced lung adenocarcinoma patients treated with afatinib. WJOG8114LTR - Liquid biopsy study of afatinib.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015847

Enrollment

Registered

2014-12-05

Start date

2015-02-20

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

EGFR mutated, advanced lung adenocarcinoma

Interventions

Afatinib 40mg/day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathologically confirmed lung adenocarcinoma 2) EGFR-TKI na&iuml;ve, recurrence / advanced case 3) Activating EGFR mutation is confirmed by tumor tissue 4) The remaining tumor tissue is available for this study. 5) Age >= 20 years 6) ECOG performance 0-1 7) With measurable target lesion as per RECIST 1.1 8) With adequate organ function 9) Expecte survival time is more than 90 days. 10) Provided written informed consent

Exclusion criteria

Exclusion criteria: 1) Incapable of oral intake 2) With intestinal paralysis, or ileus 3) Chronic diarrhea 4)Exhibiting significant interstitial pneumonitis, or pulmonary fibrosis in the chest CT 5) Uncontrolled pleural / pericardial effusion, and ascites. 6) Symptomatic brain metastasis, or meningitis carcinomatosa. 7) Prior history of thoracic radiotherapy within 4 weeks 8) Prior surgery within 4 weeks 9) Active infection 10) Positive for HBs antigen 11) With severe complication 12) Concomitant cancers within 5 years 13) History of serious drug allergies 14) Patients requiring systemic steroid medication 15) With clinically problematic, psycho-neurologic diseases 16) Pregnancy, breast feeding, or hesitation in contraception 17) Other conditions not suitable for this study

Design outcomes

Primary

Measure	Time frame
Concordance rate of EGFR mutation status between tumor tissue and serum.	—

Secondary

Measure	Time frame
Clinical outcome; overall response rate, progression-free survival, and safety Biomarker analyses; EGFR mutation analysis using digital PCR method; 1. Tumor tissue and serum (before and after afatinib treatment), and 2. quantitative monitoring in serum Comprehensive analyses using next generation sequencing; tumor tissue and serum (before and after afatinib treatment) EGFR mutation (exon 19 deletion) analysis using blocking oligo dependent PCR method; tumor tissue and serum (before and after afatinib treatment)	—

Measure

Time frame

Clinical outcome; overall response rate, progression-free survival, and safety Biomarker analyses; EGFR mutation analysis using digital PCR method; 1. Tumor tissue and serum (before and after afatinib treatment), and 2. quantitative monitoring in serum Comprehensive analyses using next generation sequencing; tumor tissue and serum (before and after afatinib treatment) EGFR mutation (exon 19 deletion) analysis using blocking oligo dependent PCR method; tumor tissue and serum (before and after afatinib treatment)

—

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group datacenter

datacenter@wjog.jp06-6633-7400

Outcome results

None listed

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