221861 - Organoid Study
Research type
Research Study
Full title
A pilot/exploratory study to evaluate response to dostarlimab and pembrolizumab in patient-derived organoids and by zirconium-89 labelled programmed death ligand 1 positron emission tomography in participants with recurrent non-small cell lung cancer (NSCLC)
IRAS ID
1008730
Contact name
Sheetal Agarwal
Contact email
Sponsor organisation
GSK Research & Development Limited
Research summary
A pilot/exploratory translational study to evaluate response to dostarlimab and pembrolizumab in patient-derived organoids (PDO) and by zirconium-89 labelled programmed death ligand 1 positron emission tomography in participants with recurrent non-small cell lung cancer.
An organoid is a miniaturised version of organ, taken from a patient and grown in 3D, mimicking the organ from which they originate. They are used to study how cells interact together in an organ/tumour, with their environment, how diseases affect them and the effect of drugs.
The purpose is to evaluate the relationship between PDL1 expression in PDOs, untreated vs. treated with chemotherapy in combination with anti-PD1 antibody, and the percentage change in uptake on 89Zr-durvalumab-PET imaging collected before and on treatment with 1L systemic therapy in NSCLC patients with recurrent disease in the advanced/metastatic setting.
The participants are allocated to one of the following treatment groups in a 1:1 ratio. Drugs will be given as infusions in the blood every 3 weeks (21 days):
1. Pembrolizumab 200mg IV ± Platinum Based Chemotherapy doublet (PBCD)
2. dostarlimab 500mg IV ± PBCD
PBCD = pemetrexed 500mg/m2 IV Q3W + either cisplatin 75mg/m2 IV Q3W for 4 cycles or carboplatin (AUC 5 mg/mL/min, maximum dose 750mg) IV Q3W for 4 cycles
A participant’s time on study includes screening (28 days), baseline 18F-FDG PET imaging, 89Zr-durvalumab-PET imaging, treatment period and on-treatment 89Zr-durvalumab-PET imaging after first dose. Participants continue treatment up to 35 cycles, disease progression, unacceptable side-effects, or death. Tests include, not limited to, blood tests, imaging (PET/CT/MRI) scans, tumour biopsy and vital signs.
Once criteria for stopping treatment is reached, participants enter safety follow-up period (30 and 90 days after last dose), survival follow-up 180 days after last dose (then every 90 days).
The study will include up to 40 participants, all in the UK.REC name
London - Hampstead Research Ethics Committee
REC reference
24/LO/0048
Date of REC Opinion
1 Mar 2024
REC opinion
Further Information Favourable Opinion