Phase I,II study ofPemetrexed and Concurrent Radiotherapy for Previously Untreated Elderly Patients With Locally Advanced Non-Squamous Non-Small Cell Lung Cancer

Pem+RT PI/II for ENSqNSCLC - Pem+RT PI/II for ENSqNSCLC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000040926

Enrollment

Registered

2020-06-28

Start date

2012-09-01

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

Lung Cancer

Interventions

Thoracic Radiation Therapy (once daily for 5 consecutive days of each week, total dose 60 Gy)+ Pemetrexed (400mg/m2) treatment on days 1, 22 and every 3weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Aged 75 and over. Histologically and/or cytologically confirmed stage IIIA or IIIB NSqNSCLC, inoperable disease, no history of chemotherapy or RT, an Eastern Cooperative Oncology Group performance status (PS) of 0 or 1, a life expectancy of 12 weeks or longer, adequate organ function (a leukocyte count of 4000/uL and over, a neutrophil count of 2000/uL and over, a hemoglobin level of 10 g/dL and over, a platelet count of 100000/uL and over, a serum bilirubin level of 1.5 mg/dL and over, serum alanine aminotransferase and aspartate aminotransferase levels 2 and over times higher than the upper limit of normal, and a serum creatinine level of 1.5 mg/dL and over), and an oxyhemoglobin saturation (SpO2) level (as measured by pulse oximetry) of 95% and over (in room air). No other form of cancer and determined by a radiologist as able to undergo RT safely (V20 and over 35%)

Exclusion criteria

Exclusion criteria: T3N1 disease; having suffered a myocardial infarction within the previous three months; uncontrolled diabetes mellitus, an active infection, interstitial pneumonia (confirmed by chest X-ray), cerebrovascular disease, symptomatic pericardial effusion, symptomatic superior vena cava syndrome, or a history of significant neurological or psychiatric disorders; severe heart disease, such as uncontrolled angina pectoris, heart failure, hyper- tension, or arrhythmia; positivity for the hepatitis B surface antigen; or any other complications that made the subject unsuitable for this trial

Design outcomes

Primary

Measure	Time frame
Determination of maximum tolerated dose.	—

Countries

Japan

Contacts

Public ContactShinnosuke Takemoto

Nagasaki University Hospital Department of respiratory medicine

shinnosuke-takemoto@umin.ac.jp095-819-7273

Outcome results

None listed

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