A randomized phase II trial of Pemetrexed or Pemetrexed plus Carboplatin followed by maintenance Pemetrexed therapy for elderly chemotherapy naive stage IIIB/IV or postoperative recurrence non-squamous non-small cell lung cancer patients

A randomized phase II trial of Pemetrexed or Pemetrexed plus Carboplatin followed by maintenance Pemetrexed therapy for elderly chemotherapy naive stage IIIB/IV or postoperative recurrence non-squamous non-small cell lung cancer patients - A randomized phase II trial of Pemetrexed or Pemetrexed plus Carboplatin followed by maintenance Pemetrexed therapy for elderly chemotherapy naive stage IIIB/IV or postoperative recurrence non-squamous non-small cell lung cancer patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008928

Enrollment

100

Registered

2012-09-19

Start date

2010-12-24

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-squamous non-small cell lung cancer

Interventions

Four cycles of Pemetrexed+ Carboplatin followed by maintenance Pemetrexed in 3 weeks cycles until progression disease Four cycles of Pacritaxel followed by maintenance Pemetrexed in 3 weeks cycles unt

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed nonsqamous non-small cell lung cancer 2) Stage III/VI without any indications for radiotherapy, or recurrent disease after surgery 3) No prior chemotherapy or oral postoperative adjuvant chemotherapy stopped more than one month before 4) Patients who have measurable lesion 5) ECOG PS 0-1 6) Patients aged 75-84 7) No prior chemotherapy for primary lesion 8) No prior chemotherapy nor radiation therapy for other cancers 9) Patients are excepted to live at least 3 months 10) Adequate organ function, evaluated within 14 days before enrollment WBC >=4,000/mm3 Neu >=2,000/mm3 Plt >=100,000/mm3 Hb>=9.0g/dl AST<=100IU/l, /ALT<=100IU/l T.Bil<=2.0mg/dl sCr<=1.0mg/dl SpO2>= 90% or PaO2>= 60torr 11) Written informed consent from the patients

Exclusion criteria

Exclusion criteria: 1) Apparent interstitial pneumonia or pulmonary fibrosis detectable on Chest CT 2) Serious complications as follows; 1.Uncontrollable angina pectoris, acute myocardial infarction or congestive heart failue, etc within 1 year 2.Uncontrollable diabetes mellitus and hypertenson 3.Active infectious disease 4. intestinal paralysis or intestinal obstruction 5. Other Serious complications 3) Patiens has pleural effusion, pericardial effusion and ascites to need treatment 4) symptomatic brain metastasis 5) SVC syndrome 6) Active double cancer 7) Pregnancy, breast feeding and suspected or wish of pregnancy 8) Patients who have serious drug hypersensitivity reaction 9) Patients whose participation in the trial is judged to be inappropriate because of psychiatric disease or psychiatric symptoms 10) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor

Design outcomes

Primary

Measure	Time frame
Progression Free Survival (PFS)	—

Secondary

Measure	Time frame
Response rate (RR), Disease control rate (DCR) overall survival (OS), Safety	—

Countries

Japan

Contacts

Public ContactHiroyuki Sakashita

Tokyo Medical and Dental university Department of Integrated Pulmonology

Outcome results

None listed

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