Actively Recruiting
Evaluation of Response to Dostarlimab and Pembrolizumab Using Extracellular Vesicles, Patient-derived Organoids, and Zirconium-89 PDL1 PET Imaging in Recurrent Non-small Cell Lung Cancer
Led by GlaxoSmithKline · Updated on 2026-02-03
40
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how well certain biomarker tools can predict responses to standard treatments in people with recurrent non-small cell lung cancer (NSCLC) at advanced or metastatic stages. The study focuses on tools including Extracellular Vesicles (EVs), Patient-derived Organoids (PDOs), and PDL1 PET imaging to evaluate how these markers relate to treatment outcomes. This pilot and exploratory study involves participants who have had operable stage 1-3 NSCLC that recurred as advanced disease. Participants are randomly assigned to receive pembrolizumab or dostarlimab, with or without a platinum-based chemotherapy doublet (PBCD) consisting of pemetrexed plus carboplatin or cisplatin. Treatment is given as part of first-line systemic therapy for advanced/metastatic NSCLC. The study includes imaging with Zirconium-89 labelled PDL1 PET to assess immune markers and collects samples for PDO and EV analysis to monitor changes in PDL1 expression. During the trial, participants undergo tumor biopsies, imaging scans like CT or MRI, and blood sampling to evaluate biomarker changes and tumor response. Safety is monitored through reports of adverse events following the PET tracer injection and throughout the treatment period. The main outcome measured is the correlation between PDL1 changes in PDOs, EVs, and PET imaging with treatment response, with follow-up lasting up to around 34.5 months. Organ function and performance status are assessed regularly to ensure participant safety throughout the study.
CONDITIONS
Brief Title
Evaluation of Programmed Death Ligand 1 (PDL1) Response to Treatment in Extracellular Vesicles (EVs), Patient-derived Organoid (PDOs)s and Immune-marker Positron Emission Tomography (PET) Scanning in Non-small Cell Lung Cancer (NSCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically or cytologically confirmed NSCLC with recurrent advanced or metastatic disease after initial diagnosis of stage 1-3 lung cancer
- Must have been initially diagnosed with operable stage 1-3 NSCLC and received curative resection with or without (neo)adjuvant treatment
- Known PDL1 status before randomization
- Biopsy-confirmed recurrence of initial NSCLC with advanced or metastatic presentation
- At least one measurable lesion per RECIST v1.1 by CT or MRI
- Deemed appropriate for first-line systemic therapy including anti-PD1 with or without platinum-based chemotherapy doublet
- Tissue submitted for attempted patient-derived organoid generation
- Participants with HIV allowed if meeting specific viral load, CD4 count, and treatment criteria
- Fresh tumor biopsy required if feasible; archival sample allowed if not
- Eastern Cooperative Oncology Group Performance Status of 0 to 2
- Adequate organ function as assessed by investigator
You will not qualify if you...
- Mixed lung carcinoma types other than squamous cell or adenocarcinoma unless approved
- Recent anti-PD(L)1 checkpoint inhibitor within 6 months before PET tracer injection
- Known central nervous system metastases or carcinomatous meningitis posing high risk
- Additional malignancy requiring active treatment within last 2 years unless approved
- Poor medical risk due to serious uncontrolled conditions or infections
- Pregnant or breastfeeding, or planning pregnancy during study and 150 days after last treatment dose
- Diagnosed immunodeficiency or receiving immunosuppressive therapy posing high risk
- Active HIV infection posing high risk
- Positive hepatitis B or C tests at screening or recent
- Active autoimmune disease requiring systemic treatment
- History or evidence of active pneumonitis or related lung conditions posing high risk
- Recent participation in other investigational therapy within 4 weeks prior to study drug
- Unstable liver or biliary disease
- Not recovered from major surgery complications
- Recent non-COVID-19 vaccine within 7 days before study therapy
- Prior anti-cancer therapy for lung cancer recurrence post-surgery
- Receiving other experimental therapies during study
- NSCLC with known EGFR, ALK, or ROS1 mutations
- History of severe allergic reactions to study drugs or components
- Recent symptomatic herpes zoster
- Active or latent tuberculosis
- Prolonged QTc interval above specified limits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 34.5 months
Participants receive pembrolizumab or dostarlimab with or without platinum-based chemotherapy doublet as first-line systemic therapy for recurrent advanced or metastatic NSCLC.
Visits scheduled per treatment protocol including imaging and biopsy assessments
Duration - Up to approximately 34.5 months
Participants are monitored for treatment response, adverse events, and long-term outcomes after treatment completion.
Regular follow-up visits as per study schedule
Trial Site Locations
Total: 1 location
1
GSK Investigational Site
London, United Kingdom, SE1 9RT
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
E
EU GSK Clinical Trials Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here