Phase II study on biweekly combination therapy of gemcitabine plus carboplatin for the treatment of elderly patient with advanced non-small cell lung cancer

Phase 2

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

• Registration Number: JPRN-UMIN000037280
• Lead Sponsor: Clinical Research Support Center Kyushu

Brief Summary

ORR: 29.2%(95%CI: 17.0-44.1) PFS: 178days(95%CI 122-198) OS: 398days

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2007-12-31
• Study Start: 2019-07-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rresponse rate (RR)

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS) Overall survival (OS) Safety