Phase I/II trial of Carboplatin plus Pemetrexed in elderly patients with advanced non squamous non small cell lung cancer

Phase I/II trial of Carboplatin plus Pemetrexed in elderly patients with advanced non squamous non small cell lung cancer - Phase I/II trial of Carboplatin plus Pemetrexed in elderly patients with advanced non squamous non small cell lung cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004629

Enrollment

Registered

2010-11-27

Start date

2010-11-01

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

Clinical stage IV non squamous non small cell lung cancer chemotherapy naive patients over 70years old

Interventions

We register patients in this trial from May 2010 to April 2012 and we will follow them another two years. We administer Carboplatin AUC4 plus Pemetrexed 500mg/m2 every 3 weeks and determine the RD aft

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of non small cell lung cancer and non squamous cell lung cancer confirmed either histologically or cytologically Recurrence after operation or clinical stage IV No prior chemotherapy Elderly patients over 70 years old ECOG Performance status 0-1 Adequate bone marrow reserve and organ function A measurable lesion according to the Response Evaluation Criteria in Solid Tumors A projected life expectancy of at least 3 months Written informed consent

Exclusion criteria

Exclusion criteria: Squamous cell carcinoma Radiation therapy to primary cancer SVC syndrome Severe drug allergy Severe pleural effusion or uncontrollable pleural effusion Severe ascites or pericardiac effusion Active infection Symptomatic brain metastasis Active concomitant malignancy Active mental illness

Design outcomes

Primary

Measure	Time frame
Response rate	—

Secondary

Measure	Time frame
1 year survival rate, Progression free survival, Safety, QOL	—

Countries

Japan

Contacts

Public ContactShinya Sakata

Kumamoto university hospital Respiratory medicine

sakata-1027@hotmail.co.jp0963735012

Outcome results

None listed

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