A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.

A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer. - A Phase II study of Pemetrexed plus Carboplatin followed by maintenance Pemetrexed in patients with previously untreated stage III/IV or post-operative recurrent non-squamous non-small-cell and lung cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003755

Enrollment

Registered

2010-06-15

Start date

2010-01-01

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-squamous non-small cell lung cancer

Interventions

Four cycles of Pemetrexed + Carboplatin followed by maintenance Pemetrexed until disease progression

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed non-sqamous non-small-cell lung cancer with Chemo-naive patients (Radiothrapy to any place other than primary and evaluable lesion is competent) 2) Patients who have measurable lesion (In 10mm Slice CT more than 20mm, in 5mm Slice CT more than 10mm) or evaluable lesion by RECIST 3) Stage III/IV without indication for curative resection and irradiation or post-operative recurrent disease without adjuvant chemotherapy or with at least one year interval from the last dosage of adjuvant chemotherapy 4) Patients aged 20 years or older 5) Karnofsky performance status 70-100 6) Adequate organ function, evaluated within 14 days before enrollment as; WBC >= 4,000/mm3 Neu >= 2,000/mm3 Plt >= 100,000/mm3 Hb >= 9.5 g/dL AST/ALT <= x 3 upper limit of normal range T. Bil <= 1.5 g/dL Ccr >= 60mL/min or sCr <= 1.2mg/dL SpO2 >= 93% as room air 7) Excepted to live over 3 months after administration day 8) Written informed consent from the patients

Exclusion criteria

Exclusion criteria: Patients with at least one of the following conditions are ineligible 1) squamous cell carcinoma 2) Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray 3) Pleural effusion, pericardial effusion and ascites to need treatment 4) Patients unable to take or unsupplied with folic acid and vitamin B12 5) Severe renal function disorder 6) SVC syndrome 7) Brain metastases with neurological symptoms 8) Active double cancer 9) Uncontrollable diabetes mellitus and hypertenson 10) Liver cirrhosis by image findings or laboratory examinations 11) History of severe heart disease (myocardial infarction within 6 months, unstable angina, post-PTCA or CAGB, signs of congestive heart failue, arrythmia with past history of heart failure, etc.) 12) Pregnancy, breast feeding and suspected pregnancy 13) History of grave drug allergic reaction 14) Acute inflammatory disease 15) An agreement is not obtained for support therapy such as transfusion etc 16) Having the bleeding tendency which is clinically apparent 17) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor

Design outcomes

Primary

Measure	Time frame
One year survival	—

Secondary

Measure	Time frame
Evaluation of safety, Objective response rate, Progression Free Survival	—

Countries

Japan

Contacts

Public ContactTakashi Kijima

Osaka University Hospital Dept. of Respiratory Medicine

tkijima@imed3.med.osaka-u.ac.jp06-6879-3833

Outcome results

None listed

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