*Phase 2 Platform Study of Novel Immunotherapy Combinations in 1L Advanced/Metastatic NSCLC Patients
Research type
Research Study
Full title
A Phase 2, Randomized, Open-label Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants with Previously Untreated Locally Advanced/Metastatic Programmed Death Ligand 1-Positive Non Small Cell Lung Cancer
IRAS ID
1006067
Contact name
Claire McDonald
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2021-005115-32
Clinicaltrials.gov Identifier
Research summary
Dostarlimab is approved in the UK for treatment of endometrial cancer. This study is being carried out to determine if dostarlimab combined with investigational agents GSK4428859A and GSK6097608 are effective in treating non-small cell lung cancer (NSCLC). Dostarlimab GSK4428859A and GSK6097608 are types of antibodies being developed by GSK to help the immune system recognise and fight cancer cells.
The purpose of this study is to assess the effectiveness and safety of five different combinations of treatment compared to the standard of care treatment pembrolizumab in participants with newly diagnosed advanced NSCLC. The participants will be randomly allocated to one of the following treatment groups by computer. The participant and study doctors will know which treatment they are receiving. The drugs will be given as infusions into the blood every 3 weeks.
1. pembrolizumab arm
2. dostarlimab arm
3. Substudy-1A: dostarlimab + GSK4428859A 100mg
4. Substudy-1B: dostarlimab + GSK4428859A 400mg
5. Substudy-1C: dostarlimab + GSK4428859A High Dose
6. Substudy-2: dostarlimab + GSK4428859A + GSK6097608
The study will determine how effective the combination treatment is compared to pembrolizumab. A participant’s time on study will include screening (28 days) and treatment period. Participants may continue study treatment until disease progression, unacceptable side-effects, or death. Tests undertaken will include, but not limited to, blood tests, imaging (CT/MRI) scans and vital signs. Participants will also undergo a medical history review and complete questionnaires about their quality of life/symptoms. Once criteria for stopping treatment is reached the participants will enter a safety follow-up period that will last for up to 90 days after the last dose. Survival follow-up will continue every 90 days until death, withdrawal of consent, loss to follow-up, or the end of study data collection. This study will include up to 300 participants globally, 8 in the UK.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
22/EE/0185
Date of REC Opinion
13 Dec 2022
REC opinion
Further Information Favourable Opinion