A randomized phase 2 study of maintenance pemetrexed versus docetaxel following pemetrexed plus carboplatin in advanced non-small cell lung cancer

A randomized phase 2 study of maintenance pemetrexed versus docetaxel following pemetrexed plus carboplatin in advanced non-small cell lung cancer - Maintenance pemetrexed versus docetaxel following pemetrexed plus carboplatin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004075

Enrollment

Registered

2010-08-31

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

advanced non-small cell lung cancer

Interventions

Patients were included in the run-in phase (four cycles of carboplatin plus pemetrexed).The end of the run-in phase, patients who did not have progressive disease were randomly allocated to pemetrexed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All participants must meet the following criterias 1: Histologically or pathologically proven NSCLC 2: Radiographically measurable lesion 3: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 4: Stage 3B/4 NSCLC 5: Age more than 20 years and less than 75 years 6: Neutrophil count: more than 1,500/uL Platelet count: more than 100,000/uL Hemoglobin: more than 9.0 g/dL Aspartate transaminase (AST), alanine transaminase(ALT): 2.5 times the upper limit of normal of the institutional reference range Total bilirubin: less than 1.5mg/dL. PaO2: more than 60 torr Creatinine: less than 1.2mg/dL or a calculated creatinine clearance more than 45 mL/min 7: Life expectancy of more than 12 weeks 8: Written informed consent

Exclusion criteria

Exclusion criteria: Exclusion criterias are as follows 1: Squamous cell carcinoma 2: Active interstitial pneumonia identified by chest X-ray 3: Uncontrolled massive pleural effusion or cardiac effusion 4: Superior vena cava syndrome 5: Uncontrolled brain metastases 6: Uncontrolled diabetes mellitus, hypertension, hepatic disorder, angina pectoris or previous myocardial infarction within the last 12 months 7: Severe infection 8: Pregnancy or lactation 9: Active concomitant malignancy 10: History of severe allergic reactions to drugs 11: Severe and unstable medical comorbidities 12: Judgment to attending physician

Design outcomes

Primary

Measure	Time frame
survival without grade 3/4 toxicity	—

Secondary

Measure	Time frame
response rate, overall survival, progression free survival, safety	—

Countries

Japan

Contacts

Public ContactNaoki inui

Hamamatsu University School of Medicine Clinical Pharmacology and Therapeutics

Outcome results

None listed

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