Actively Recruiting
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)
Led by GlaxoSmithKline · Updated on 2026-02-03
40
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to investigate the utility of biomarker tools Extracellular Vesicles (EVs), Patient-derived organoid (PDOs), and PDL1 PET imaging for predicting how participants with recurrent NSCLC respond to standard of care treatment in the advanced/metastatic stages.
CONDITIONS
Official 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 documented NSCLC presenting with recurrent advanced or metastatic disease after initial diagnosis of Stage 1-3 lung cancer
- Participants must have been initially diagnosed with operable Stage 1-3 NSCLC and received curative resection with or without (neo)adjuvant treatment
- Identifiable PDL1 status before randomization
- Participants must have biopsy-confirmed recurrence of their initial NSCLC with advanced or metastatic presentation
- Must have at least 1 measurable lesion per RECIST v1.1 by CT or MRI (lesions previously irradiated are not considered measurable)
- Must be deemed appropriate by investigator to receive first-line systemic therapy (anti-PD1 with or without chemotherapy)
- Must have had tissue submitted for attempted patient-derived organoid (PDO) generation, confirmed by biobank pathologist
- Participants with HIV infection allowed if plasma HIV-1 RNA <50 copies/mL for at least 3 months prior to screening and CD4 cell count >350 cells/mm3 over past 12 months and at screening
- Must be on uninterrupted combination antiretroviral therapy consistent with guidelines for at least 3 months prior to screening
- Participants with treated or stable CDC Stage 3 AIDS-defining diseases (except HIV-associated lymphoma within 5 years) allowed
- Fresh tumor biopsy required if feasible and safe; archival biopsy allowed if fresh not available
- Eastern Cooperative Oncology Group Performance Status of 0 to 2
- Adequate organ function per investigator
You will not qualify if you...
- Mixed lung carcinoma types including small cell carcinoma, large cell neuroendocrine carcinoma, sarcomatoid carcinoma, or other histologies not benefiting from anti-PD1 therapy
- Prior anti-PD(L)1 checkpoint inhibitor therapy within 6 months before first PET tracer injection if received as adjuvant therapy
- Known CNS metastases or carcinomatous meningitis posing high risk
- Additional malignancy that progressed or required treatment within 2 years unless approved by Medical Monitor
- Serious uncontrolled medical disorders, active infections, or psychiatric/substance abuse disorders interfering with study participation
- Pregnant, breastfeeding, or planning pregnancy during study through 150 days after last study dose
- Diagnosed immunodeficiency or receiving systemic steroids or immunosuppressive therapy posing high risk
- Active HIV infection posing high risk
- Positive hepatitis B or C infection at screening or within 3 months before first cancer treatment dose
- Active autoimmune disease requiring systemic treatment except allowed replacement therapies
- History or evidence of active pneumonitis or interstitial lung diseases posing high risk
- Participation in another investigational study or therapy within 4 weeks before first study drug dose
- Cirrhosis or unstable liver/biliary disease with specific complications
- Not recovered from major surgery complications to grade 1 or better before therapy
- Recent vaccination other than COVID-19 vaccine; restrictions on certain COVID-19 vaccine types within 30 days before therapy
- Received anti-cancer therapy for lung cancer recurrence after surgery
- Receiving other anticancer or experimental therapies during study intervention
- NSCLC with known sensitizing EGFR, ALK, or ROS1 mutations at initial surgery or screening biopsy
- History of severe allergic reactions to study drugs or related antibodies
- Symptomatic herpes zoster within 3 months before screening
- Active or latent tuberculosis documented by tests
- Prolonged QTc interval exceeding defined thresholds
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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