A Phase I Study of Pemetrexed, Carboplatin, and Radiation Therapy in Locally Advanced Non-Squamous-Cell, Non-Small-Cell Lung Cancer

A Phase I Study of Pemetrexed, Carboplatin, and Radiation Therapy in Locally Advanced Non-Squamous-Cell, Non-Small-Cell Lung Cancer - PRINCE

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014330

Enrollment

Registered

2014-06-23

Start date

2013-02-01

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

elderly patients with localy advanced non-small-cell lung cancer

Interventions

CBCDA: AUC4-5, weekly PEM:500mg/m2, weekly concurrent TRT: 2Gy/day todal 60Gy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically or cytologically confirmed non-sqamous non-small-cell lung cancer with Chemo-naive patients 2) Stage III, without indication for curative resection, with irradiation 3) Patients aged 75- years 4) ECOG performance status 0-1 5) Adequate organ function 6) Excepted to live over 3 months after administration day 7) Written informed consent from the patients

Exclusion criteria

Exclusion criteria: 1) squamous cell carcinoma 2) Interstitial pneumonia or pulmonary fibrosis detectable on Chest X-ray 3) Pleural effusion, pericardial effusion and ascites to need treatment 4) Severe renal function disorder 5) SVC syndrome 6) Brain metastases with neurological symptoms 7) Active double cancer 8) Uncontrollable diabetes mellitus and hypertenson 9) Liver cirrhosis by image findings or laboratory examinations 10) History of severe heart disease (myocardial infarction within 6 months, unstable angina, post-PTCA or CAGB, signs of congestive heart failue, arrythmia with past history of heart failure, etc.) 11) Pregnancy, breast feeding and suspected pregnancy 12) History of grave drug allergic reaction 13) Acute inflammatory disease 14) An agreement is not obtained for support therapy such as transfusion etc 15) Having the bleeding tendency which is clinically apparent 16) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor

Design outcomes

Primary

Measure	Time frame
To determine the maximum-tolerated dose (MTD)	—

Secondary

Measure	Time frame
ORR, PFS, OS	—

Countries

Japan

Contacts

Public ContactNaruo Yoshimura

Osaka City University Hospital Chemotherapy center

y-naruo@sc4.so-net.ne.jp06-6645-3793

Outcome results

None listed

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