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A Phase 2 Study of Pemetrexed in Patients with Previously Treated Non-Squamous Non-Small-Cell Lung Cancer

A Phase 2 Study of Pemetrexed in Patients with Previously Treated Non-Squamous Non-Small-Cell Lung Cancer - A Phase 2 Study of Pemetrexed in Patients with Previously Treated Non-Squamous Non-Small-Cell Lung Cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002467
Enrollment
45
Registered
2009-09-09
Start date
2009-08-01
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

Previously treated non-squamous non-small cell lung cancer

Interventions

Sponsors

Kobe Lung Cancer Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proven non-squamous non-small cell lung cancer (without large cell neuroendocrine carcinoma) 2)Non-squamous non-small cell cancer patients with stage IIIB,stage IV or recurrent disease after surgery,who have previously treated 2-5 chemoterapy regimens 3)Measurable lesions not required 4)More than 4 weeks after the last chemoterapy (More than 2 weeks after the last UFT,TS-1,gefitinib and erlotinib) 5)If the patient underwent radiotherapy, there should be the following interval between the radiotherapy and the registration i)Radiotherapy including pulmonary field ->3 months ii)Radiotherapy other than thoracic radiation ->1 month 6)20 years or older 7)ECOG PS 0-2 8)Adequate organ function 9)Life expectancy more than 3 months 10)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan 2)History of drug induced interstitial pneumonia 3)History of severe drug allergy 4)History of active infection or other serious disease condition (GI bleeding,etc.) 5)History of poorly controlled pleural effusion,pericardial effusion and ascites 6)History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris,herat failure,etc.) 7)Uncontrollable diabetes mellitus 8)History of symptomatic brain metastases 9)Hystory of active double cancer 10)History of active psychological disease 11)History of pregnancy or lactation 12)Patients whose participation in the trial is judged to be inappropriate by the attending doctor

Design outcomes

Primary

MeasureTime frame
Progression free survival

Secondary

MeasureTime frame
Overall survival Response rate Disease control rate Safety

Countries

Japan

Contacts

Public ContactYoshihiro Hattori

Hyogo Cancer Center Department of Thoracic Oncology

hattori@hp.pref.hyogo.jp078-929-1151

Outcome results

None listed

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