A randomized phase II trial of docetaxelor pemetrexed with or without gefitinib in elderly advanced non-small cell lung cancer patients harboring activating EGFR mutation after failure of the therapy as first-line treatment.

A randomized phase II trial of docetaxelor pemetrexed with or without gefitinib in elderly advanced non-small cell lung cancer patients harboring activating EGFR mutation after failure of the therapy as first-line treatment. - A randomized phase II study of continuou gefitinib plus docetaxel or pemetrexed in elderly gefitinib responders (JMTO LC 12-01)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007765

Enrollment

Registered

2012-04-16

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

non-small cell lung cancer

Interventions

Group A: docetaxel or pemetrexed Group B: docetaxel or pemetrexed plus gefitinib

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Histologically or cytologically confirmed non-squamous non-small lung cancer 2.Harboring activating EGFR mutation including exon 19 deletion mutation and/or L858R point mutation 3.Previously treated gefitinib as first-line treatment and had good response (CR, PR or SD for more than 6 months accroding to Jackman cliteria) 4.Maintained gefitinib administered according to regular treatment schedule for more than 3 months 5.Platinum-based doublet chemotherapy is not recommended 6.Advanced or metastatic NSCLC (Stage IIIB/IV) and unsuitable for radiotherapy 7.Patients with evaluable disease 8.PS:0-2 (ECOG) 9.70 years or older 10.Sufficient organ function WBC >=4000/mm3 Neutrophil >=2000/mm3 Plt >=100000/mm3 Hb >=9.0 g/dL Both AST and ALT <=100IU/L Total bilirubin: <=1.5 mg/dl Serum creatinine: <=1.2 mg/dl SpO2>=93% 11.A life expectancy of 3 months or more 12.Submission of written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients including clients and employee or stuff of the participating medical institution who are involved in planning and conducting this study 2.Patients who relapsed in one year from the last day of adjuvant chemotherapy 3.Active infection (fever of 38.0 degrees centigrade or higher) 4.Patients with past history including acute interstitial pneumonia, pulmonary drug toxicity and radiation pneumonitis treated with corticosteroids 5.Interstitial pneumonia/ Pulmonary fibrosis 6.Patietns with ileus 7.Uncontrollable diarrhea 8.Active double cancer 9.Serious allergy history 10.Patients with refractory gastric ulcer or a duodenal ulcer 11.Uncontrollable massive,pleural effusion or cardiac effusion 12.Systemic administartion of corticosteroids 13.History of docetaxe or pemetrexed therapy 14.serious medical complications (uncontrollable pulmonary disease, heart disease, kidney disease, liver disease) and inappropriate patients for this study judged by the physicians physician

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Response Rate Disease Control Rate Overall survival Safety	—

Countries

Japan

Contacts

Public ContactKazuhiro Asami

National Hospital Organization Kinki-chuo Chest Medical Center Medical Oncology

asami@kch.hosp.go.jp072-252-3021

Outcome results

None listed

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