* CAAA601A42101- Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Research type
Research Study
Full title
A Phase Ib Dose Finding Study Assessing Safety and Activity of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Extensive Stage Small Cell Lung Cancer (ES-SCLC) in Combination with Carboplatin, Etoposide and Tislelizumab in Induction, and Tislelizumab in Maintenance Treatment Phase
IRAS ID
1004607
Contact name
Cristiana Balcu
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2021-004155-16
Clinicaltrials.gov Identifier
Research summary
Small cell lung cancer is fast-growing lung cancer that develops in the tissues of the lungs. Small cell lung carcinoma (SCLC) is the most lethal and aggressive subtype of lung cancer and 80–85% of patients present with extensive disease at diagnosis. This is a phase 1b study with the aim of evaluating the safety of [177Lu]Lu-DOTA-TATE (Lutathera) in patients with extensive stage small cell lung cancer (ES-SCLC) and to find the appropriate dose of Lutathera in combination with carboplatin, etoposide and tislelizumab.
Lutathera is a radioligand therapy, which is a targeted treatment that selectively delivers radiation to the tumour, with limited damage to surrounding tissues. Lutathera has been administered to more than 9,000 patients with neuroendocrine tumours. It has also been administered to a small number of ES-SCLC patients. However, this is the first study where Lutathera will be administered in combination with carboplatin, etoposide and tislelizumab.
This study will include approximately 39 female and male participants with newly diagnosed ES-SCLC. Participants will be in the study for about 4 weeks of screening, 6-9 months in the treatment period, and additionally for 12 months during the follow up period. Participants will be enrolled in this study in groups of 3-6 people (called cohorts), to receive different dose levels of Lutathera in combination with tislelizumab and carboplatin/etoposide. Several dose levels of Lutathera will be tested in the study.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
22/EE/0186
Date of REC Opinion
21 May 2022
REC opinion
Further Information Favourable Opinion