A randomized phase II study of pemetrexed versus pemetrexed plus carboplatin in chemotherapy-naive elderly patients with IIIB/IV non-squamous non-small cell lung cancer.

A randomized phase II study of pemetrexed versus pemetrexed plus carboplatin in chemotherapy-naive elderly patients with IIIB/IV non-squamous non-small cell lung cancer. - A randomized phase II study of MTA versus MTA plus CBDCA in elderly patients with IIIB/IV non-squamous NSCLC.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006129

Enrollment

Registered

2011-08-08

Start date

2011-05-01

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-naive elderly patients with IIIB/IV non-squamous non-small cell lung cancer

Interventions

Pemetrexed 500mg/m2 Day1 q21days until PD Pemetrexed 500mg/m2 Day1, Carboplatin AUC5 Day1 q21days*4cycles Maintenance Pemetrexed 500mg/m2 Day1 q21days until PD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proven non-squamous non-small cell lung cancer 2)With measurable lesion 3)ECOG PS 0-1 4)Previously untreated stage IIIB/IV patients (no indication of surgery or radiotherapy) 5)70 years or older 6)Adequate organ function 7)Life expectancy more than 3 months 8)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Squamous cell carcinoma 2)Radiation therapy to primary cancer 3)SVC syndrome 4)Severe drug allergy 5)Massive or uncontrollable pleural effusion 6)Massive ascites, or pericardial effusion 7)Recurrence of postoperative NSCLC patients 8)Active infectious diseases 9)Interstitial pneumonia recognized by chest X-ray 10)CNS metastases with symptoms 11)Active multiple cancers 12)Psychological disorders 13)Inappropriate patients for this study judged by the physicians

Design outcomes

Primary

Measure	Time frame
6 months progression free survival rate	—

Secondary

Measure	Time frame
over all survival, response rate, safety, progression free survival without grade3/4 toxicity	—

Countries

Japan

Contacts

Public ContactHirokazu Touge

Faculty of Medicine, Tottori University Division of Medical Oncology and Molecular Respirology

htouge3@med.tottori-u.ac.jp0859-38-6537

Outcome results

None listed

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