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Phase II Study of Carboplatin + Pemetrexed in chemotherapy-naive patients with advanced non-squamous non-small cell lung cancer

Phase II Study of Carboplatin + Pemetrexed in chemotherapy-naive patients with advanced non-squamous non-small cell lung cancer - Phase II Study of Carboplatin + Pemetrexed in chemotherapy-naive patients with advanced non-squamous non-small cell lung cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005583
Enrollment
35
Registered
2011-05-11
Start date
2009-11-01
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

Non-small-cell lung cancer

Interventions

Carboplatin+Pemetrexed

Sponsors

Tochigi Cancer Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed Stage 3B/4 non-small-cell lung cancer and non-squamous cell carcinoma. 2.No prior chemotherapy. 3.With one or more measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) ver1.1 4.Age 20<=, <=75 5.Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1. 6.Adequate function of vital organs, including normal hematopoietic function, normal liver function and normal renal function. 7.A life expectancy of more than 3 months. 8.All patients provided written informed consent before initiation of study-related procedures.

Exclusion criteria

Exclusion criteria: 1.Symptomatic Brain metastasis. 2.History of active double cancer. 3.Severe infection 4.Severe comorbidity (heart failure tendency to hemorrhages, uncontrollable hypertension, uncontrollable diabetes, etc) 5.Interstitial pneumonia or pulmonary fibrosis detectable on X ray. 6.With a history of drug sensitivity. 7.Pregnant or lactating women or those who declined contraception. 8.Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
Response rate

Secondary

MeasureTime frame
Overall survival Safety Progression free survival

Countries

Japan

Contacts

Public ContactTakashi Kasai

Tochigi Cancer Center Division of Thoracic Oncology

takasai@tcc.pref.tochigi.lg.jp

Outcome results

None listed

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