Chemotherapy with EGFR-tyrosine kinase inhibitor (EGFR-TKI) or chemotherapy alone in elderly patients with advanced NSCLC with acquired resistance to EGFR-TKI (NEJ017)

Chemotherapy with EGFR-tyrosine kinase inhibitor (EGFR-TKI) or chemotherapy alone in elderly patients with advanced NSCLC with acquired resistance to EGFR-TKI (NEJ017) - NEJ017

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008364

Enrollment

100

Registered

2012-07-06

Start date

2012-07-01

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

Chemotherapy and EGFR-TKI Chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients with ECOG PS 0-2 and age 70 years or older or PS2 and age younger than 75 years 2)Pathologically or cytlogically confirmed non-small cell lung cancer 3)Patients with clinical stage IIIB unsuitable for radiotherapy, stage IV or recurrent post-operative NSCLC 4) Patients with sensitive EGFR mutation confirmed by sensitive methods such as PNA-LNA PCR clump method 5)Patients with advanced NSCLC and acquired resistance to EGFR-TKIs after achieving stable disease for 6 month or more 6)Patients who had been received EGFR-TKI within 6 weeks of registration of this trial 7)Patients who had received EGFR-TKI only as the previous chemotherapy 8)Patients with evaluable disease defined by RECIST 1.1 9)Patients with adequate organ functions 10)Patients with an estimated survival of at least 3 month 11)Patients with written informed concent

Exclusion criteria

Exclusion criteria: 1)Patients with severe drug allergy 2)Patients with active infection 3)Patients who uses steroids or immunosuppressant drugs 4)Patients with uncontrollable disease 5)Patients with interstitial pneumonia or pulmonary fibrosis on chest CT 6)Patients with massive pleural effusion, ascites, pericardial effusion (drainage or pleurodesis with OK432 or minocylcine are permissive.) 7)Patients who received surgery within 3 weeks or radiotherapy within 2 weeks of registration 8)History of active double cancer within 5 years 9)Patients who have the possibility of pregnancy or in lactation period 10)Patients with symptomatic brain metastases 11)HBs antigen positive 12)Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Design outcomes

Primary

Measure	Time frame
progression-free survival	—

Countries

Japan

Contacts

Public ContactHajime Asahina

Hokkaido University First Department of Medicine

hajime.asahina@gmail.com011-706-5911

Outcome results

None listed

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