A randomized phase II study of Pemetrexed plus Carboplatin followed by Pemetrexed versus Paclitaxel plus Carboplatin followed by Pemetrexed in patients with chemotherapy na&iuml;ve non-squamous non-small cell lung cancer.

A randomized phase II study of Pemetrexed plus Carboplatin followed by Pemetrexed versus Paclitaxel plus Carboplatin followed by Pemetrexed in patients with chemotherapy na&iuml;ve non-squamous non-small cell lung cancer. - A randomized phase II study of PEM+CBDCA followed by PEM versus PTX+CBDCA followed by PEM in patients with non-squamous NSCLC.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005008

Enrollment

140

Registered

2011-02-03

Start date

2010-07-01

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

Chemotherapy na&amp

Interventions

Pemetrexed(PEM)500mg/m2 Day1, Carboplatin(CBDCA)AUC6 Day1 q3week*3cycles Maintenance Pemetrexed(PEM)500mg/m2 Day1 q3week*more than 4cycles until PD Paclitaxel(PAC)200mg/m2 Day1, Carboplatin(CBDCA) AU

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Written informed consent. Chemotherapy-naive patients with histologically or cytologically confirmed non-squamous non-small cell lung cancer. Patients aged 20 years or older. ECOG performance status of 0-1. Sufficient function of main organ and bone marrow filled the following criteria before two weeks from enrollment: WBC>=4,000/mm3, <=12,000/mm3 Plt>= 100,000/mm3 Hb >= 10g/dl AST and ALT, *2 of upper limit of normal(ULN)or less. T-Bil <= 1.5mg/d Cre <= 1.5mg/dl creatinine clearance>=60ml/min PaO2 >= 60Torr Life expectancy over 3 months

Exclusion criteria

Exclusion criteria: Severe complicaiton including heart disease, pulmonary fibrosis, bleeding tendency, uncontrollable hypertension and diabetes mellitus. Patients with symptomatic brain metastasis. Active concomitant malignancy. Past history of drug hypersensitivity. Psychiatric disorder. Systemic steroid administration.

Design outcomes

Primary

Measure	Time frame
Progression Free Survival	—

Countries

Japan

Contacts

Public ContactTaishi Harada

Kyushu University, Graduate School of Medical Sciences Research Institute for Diseases of the Chest

harada-t@kokyu.med.kyushu-u.ac.jp092-642-5378

Outcome results

None listed

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

A randomized phase II study of Pemetrexed plus Carboplatin followed by Pemetrexed versus Paclitaxel plus Carboplatin followed by Pemetrexed in patients with chemotherapy na&amp;iuml;ve non-squamous non-small cell lung cancer.