Multicenter phase II trial of continuous EGFR-TKIs for elderly patients with EGFR sensitive mutation who failed the first EGFR-TKIs treatment for advanced non-small cell lung cancer.

Multicenter phase II trial of continuous EGFR-TKIs for elderly patients with EGFR sensitive mutation who failed the first EGFR-TKIs treatment for advanced non-small cell lung cancer. - Multicenter phase II trial of continuous EGFR-TKIs for elderly patients with EGFR sensitive mutation who failed the first EGFR-TKIs treatment for advanced non-small cell lung cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008027

Enrollment

Registered

2012-05-28

Start date

2012-05-01

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

advanced non-small cell lung cancer

Interventions

A:Reference arm Chemotherapy B:Experimental arm Chemotherapy plus EGFR-TKIs continuation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Pathologically or cytologically confirmed non-small cell lung cancer. 2. Patients without previous EGFR-TKIs (gefitinib, erlotinib or afatinib) treatment for non-small cell lung cancer. 3. Patients with clinical stage IIIB unsuitable for radiotherapy or Stage IV. 4. Patients who have confirmed EGFR mutation of exon 19 deletion or Exon 21 mutation. 5. Patients have previously treated with EGFR-TKIs (gefitinib, erlotinib or afatinib) as 1st-line chemotherapy, and have a disease control at least 8weeks. Registration within 42 days after the day of disease progression confirmation. 6. Patients with tolerable adverse effect during EGFR-TKIs (gefitinib, erlotinib or afatinib) treatment 7. Age 70 year-old and over. 8. Patients with evaluable disease defined by RECIST. 9. ECOG performance status 0-2. 10. Sufficient organ function Hb >=9.0 g/dL WBC >=2000/mm3 Plt >=100000/mm3 GOT/GPT <=100IU/L Cr =<1.5mg/dL SpO2>=92% 11. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with difficulty of oral dosing continuation for 250mg gefitinib more than once in three days, more than 50 mg erlotinib every day or more than 100mg erlotinib every other day, or more than 20 mg afatinib every day. 2. Patients with active infection or uncontrollable disease. 3. Patients with clinically pulmonary disorders such as idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia or radioactive pneumonitis on chest CT. 4. Patients with induction or adjuvant chemotherapy within 12 months. 5. Patients with massive pleural effusion, ascites, pericardial effusion or SVC syndrome (drainage or pleurodesis with OK432 or bleomycin are permissive.) 6. Patients with symptomatic brain metastases or with treatment needs for steroids, anticonvulsant, etc. 7. Patients with severe drug allergy. 8. Patients with grade 3 or more diarrhea. 9. History of radiation therapy for mediastinum or lung. 10. History of active double cancer within 2 years. 11. Patients with hypersensitivity history or its suspicion to gefitinib, erlotinib and afatinib. 12. HBs antigen positive. 13. Patients who have possibility of pregnancy. 14. Patients whose participation in the trial is judged to be inappropriate by the attending doctor.

Design outcomes

Primary

Measure	Time frame
progression free survival	—

Secondary

Measure	Time frame
disease control rate on 6th, 12th and 18th treatment week, overall survival, adverse effect	—

Countries

Japan

Contacts

Public ContactMasafumi Yamaguchi

National Kyushu Cancer Center Department of Thoracic Oncology

yamaguchi.m@nk-cc.go.jp092-541-3231

Outcome results

None listed

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