Phase II study of 1st-line biweekly Gemcitabine and Carboplatin vs biweekly Gemcitabine and Carboplatin plus maintenance Gemcitabine in elderly patient untreated non-small cell lung cancer

Phase II study of 1st-line biweekly Gemcitabine and Carboplatin vs biweekly Gemcitabine and Carboplatin plus maintenance Gemcitabine in elderly patient untreated non-small cell lung cancer - LOGIK0801

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000039230

Enrollment

Registered

2020-01-23

Start date

2008-07-01

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

advanced/recurrent non-small cell lung cancer (NSCLC)

Interventions

Patients received biweekly combination therapy with GEM and CBDCA (1000 mg/m2 GEM and CBDCA at an area under the curve of 3 on days 1 and 15, every 4 weeks). Patients received biweekly combination the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients with histologically proven non-small cell lung cancer (2) Patients with measurable disease (3) Chemotherapy in patients with unreliable Stage IIIb and Stage IV or in patients with postoperative relapse Untreated patients (4) Patients with a clinical signs Performance Status of 0 to 1 (5) Patients aged 70 years or older at enrollment (6) Patients who have not received prior chemotherapy, radiation therapy, or immunotherapy (BRM) (7) Major organ functions (bone marrow, liver, kidney, etc.) are well preserved, and the following criteria are used Patients who meet WBC count: 4,000 per mm3 and 12,000 per mm3 Neutrophils: 2,000 per mm3 or more Platelets count: 100,000 per mm3 or more Haemoglobin: 9.0 g/dl or more GOT and GPTs: less than 2.5 times the normal values of the institution Total bilirubin: not more than 2.0 mg/dl Serum creatinine: not more than 1.2 mg/dl PaO2 :>= 60 Torr (8) Patients who are expected to survive for more than 3 months (9) Patients with written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: (1) Patients with obvious infections (2) Patients with fever (38C or higher) (3) Serious complications (heart disease, pulmonary fibrosis/interstitial pneumonia, bleeding tendency, uncontrolled) Patients with hypertension, diabetes mellitus, etc. (4) Patients with active double cancer (disease-free interval <5 years) (5) Symptomatic patients with brain metastases (6) Patients with pleural effusions and ascites requiring treatment (7) Patients with pericardial effusion (8) Patients with varicella (9) Patients with motor paralysis or peripheral nerve symptoms (excluding those originating from the primary disease) (10) Patients with a history of drug hypersensitivity (11) Pregnant, breastfeeding, and women of childbearing potential (willingness) (12) Other patients judged inappropriate by the investigator

Design outcomes

Primary

Measure	Time frame
PFS	—

Countries

Japan

Contacts

Public ContactJunji Uchino

Kyoto Prefectural University of Medicine Department of Pulmonary Medicine

uchino@koto.kpu-m.ac.jp075-251-5513

Outcome results

None listed

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