Randomized phase II trial of docetaxel and carboplatin in patients with stage IIIB/IV non-small cell lung cancer.

Randomized phase II trial of docetaxel and carboplatin in patients with stage IIIB/IV non-small cell lung cancer. - Randomized phase II trial of docetaxel and carboplatin in patients with stage IIIB/IV non-small cell lung cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001225

Enrollment

Registered

2008-07-01

Start date

2007-06-01

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

Stage IIIB/IV non-small cell lung cancer

Interventions

docetaxel 60mg/m2, day1 + carboplatin AUC 6mg/mLxmin, day 1 q3w, 6 cycles paclitaxel 200mg/m2, day1 + carboplatin AUC 6mg/mLxmin, day 1 q3w, 6 cycles

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)written informed consent 2)histologically or cytologically confirmed stage IIIB (inoperable or ineligible for curative radiation therapy) or IV NSCLC with no prior chemotherapy. Recurrence after surgery is categorized as stage IV. 3)At least 3 weeks passed and recovered from toxicity from prior radiation therapy or surgery if applicable. 4)Measurable disease. 5)ECOG Performance status 0 or 1. 6)Adequate organ function (1) Neutrophil count >= 2,000/mm3 (2) Platelet count >= 100,000/mm3 (3) Hemoglobin >= 9.0g/dL (4) AST/ALT within twice the upper limit of normal (ULN) of institution (5) Total bilirubin within the ULN (6) Serum creatinine within the ULN (enzyme method) (7) Creatinine clearance >= 50 mL/min 7)PaO2 >= 70 torr or SpO2 >= 94% (room air) 8)Estimated life expectancy longer than 3 months

Exclusion criteria

Exclusion criteria: 1)Patients with serious infections or suspected infections with fever. 2)Pregnant or lactating women 3)Active concomitant malignancy 4)Past history of allergic reactions to polysorbate 80 5)Patients with interstitial pneumonia or pulmonary fibrosis, as determined by chest x-ray 6)Patients with inadequately controlled complications such as hypertension, congestive heart failure, myocardial infarction, arrhythmia, bleeding and diabetes. 7)Clinically significant pleural/pericardial effusion which requires treatment 8)Symptomatic brain metastases 9)Grade 2 or greater peripheral neuropathy 10)Patients judged by the investigator as unfit to be enrolled in the study

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS)	—

Secondary

Measure	Time frame
Response rate, 1-yr survival, overall survival, safety	—

Countries

Japan

Outcome results

None listed

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