Tokyo, Feb. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060603) titled 'A retrospective study of the efficacy and safety of chemoimmunotherapy for extensive stage of small cell lung cancer in the elderly' on Feb. 7.
Study Type:
Observational
Primary Sponsor:
Institute - Niigata University Graduate School of Medical and Dental Sciences
Condition:
Condition - extensive stage of small cell lung cancer
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - In the IMpower133 and CASPIAN trials, the combination of a PD-L1 inhibitor and platinum-based chemotherapy demonstrated a significant survival benefit in patients with previously untreated extensive-stage small-cell lung cancer (ES-SCLC). The aim of this study is to evaluate the efficacy and safety of PD-L1 inhibitor plus platinum-based chemotherapy in elderly patients aged 75 years or older with ES-SCLC.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - From August 22, 2019 to April 30, 2024, patients who meet eligibility criterion (1) or (2) below and do not meet any of the exclusion criteria will be included.
Eligibility criteria:
(1) Patients with extensive-stage small-cell lung cancer diagnosed as small-cell lung cancer by histology or cytology, or patients with combined-type lung cancer who were treated as having extensive-stage small-cell lung cancer.
(2) Patients diagnosed with extensive-stage small-cell lung cancer who did not receive systemic chemotherapy and were managed with best supportive care alone.
Key exclusion criteria - (1) Patients with limited-stage small-cell lung cancer who underwent surgery, definitive radiotherapy, or chemotherapy.
(2) Patients enrolled in interventional studies (those enrolled only in observational studies are eligible).
Target Size - 200
Recruitment Status:
Recruitment status - Main results already published
Date of protocol fixation - 2024 Year 10 Month 08 Day
Date of IRB - 2025 Year 01 Month 29 Day
Anticipated trial start date - 2025 Year 03 Month 31 Day
Last follow-up date - 2026 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069306
Disclaimer: Curated by HT Syndication.