Study of SG vs Docetaxel in Patients With Advanced or Metastatic NSCLC
Research type
Research Study
Full title
Open-Label, Global, Multicenter, Randomized, Phase 3 Study of Sacituzumab Govitecan Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Progression on or After Platinum-Based Chemotherapy and Anti-PD-1/PD-L1 Immunotherapy
IRAS ID
306514
Contact name
Shobhit Baijal
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2021-003578-30
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
years, months, days
Research summary
This is a phase 3, open-label study to evaluate the safety and efficacy of Sacituzumab Govitecan (SG) versus Docetaxel in patients with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) with progression on or after platinum-based chemotherapy and Anti-PD-1/PD-L1 immunotherapy. Lung cancer is the main cause of cancer related death worldwide and approximately 80-85% of all lung cancers are NSCLC. The purpose of this study is to see if Sacituzumab Govitecan can prolong survival in participants with NSCLC, that has progressed after standard cancer therapy.
Approximately 520 participants will be randomly assigned to either the experimental group using Sacituzumab Govitecan or the control group using the standard treatment for NSCLC, Docetaxel.
Participation in the study will last approximately 18 months or longer, excluding the screening period. Regardless of which treatment group participants are assigned to (Sacituzumab Govitecan or Docetaxel), the treatment will be given in 21-day (3 week) cycles. Participants will be required to visit the study site at least 2 times per cycle whilst on treatment and every 12 weeks during follow up.
The participants will visit the study site 7 times, where they will undergo procedures such as medical history, CT or MRI scans, bone or PET scans, blood and urine tests and a physical examination including weight, height, temperature, heart rate, blood pressure, electrocardiogram (ECG). The study doctor will also review previous/current medications.
Approximately 520 participants will be randomly assigned to either the experimental group using Sacituzumab Govitecan or the control group using the standard treatment for NSCLC, Docetaxel.
Participation in the study will last approximately 18 months or longer, excluding the screening period. Regardless of which treatment group participants are assigned to (Sacituzumab Govitecan or Docetaxel), the treatment will be given in 21-day (3 week) cycles. Participants will be required to visit the study site at least 2 times per cycle whilst on treatment and every 12 weeks during follow up.
The participants will visit the study site 7 times, where they will undergo procedures such as medical history, CT or MRI scans, bone or PET scans, blood and urine tests and a physical examination including weight, height, temperature, heart rate, blood pressure, electrocardiogram (ECG). The study doctor will also review previous/current medications.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
21/SC/0385
Date of REC Opinion
2 Feb 2022
REC opinion
Further Information Favourable Opinion