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RECRUITINGPHASE1/PHASE2

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)

A Pilot/Exploratory Translational Study to Evaluate Response to Dostarlimab and Pembrolizumab in Extracellular Vesicles (EVs) or Patient-derived Organoids (PDOs) and by Zirconium-89 Labelled Programmed Death Ligand 1 Positron Emission Tomography in Participants With Recurrent Non-small Cell Lung Cancer

NCT06405230•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must have histologically- or cytologically documented NSCLC who present 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 ± (neo) adjuvant treatment
•Identifiable PDL1 status prior to randomisation
•Participants must have biopsy-confirmed recurrence of their initial NSCLC with advanced/metastatic presentation
•Has at least 1 measurable (target) lesion per Response Evaluation Criteria in Solid Tumours (RECIST) version (v) 1.1 by Computed tomography (CT) or magnetic resonance imaging (MRI). Measurable lesions that have been previously irradiated are not considered measurable and cannot be target lesions
•Participants must be deemed by investigator to be appropriate to receive 1L systemic therapy (i.e., anti-PD1 ± PBCD)
•Participants must have had tissue submitted for attempted PDO generation. (Note: patients deemed to have successfully established paired 1o PDO \[from the tumour resection at time of diagnosis\]are those whose PDO cultures have been passaged 2 times, with a reasonable proliferation rate. This designation can be made prior to or during trial participation. A KCL biobank pathologist will confirm the PDO's representation of clinical tumour tissue sample at the time of multiomic analysis).
•Participants with known human immunodeficiency virus (HIV) infection are allowed with the following requirements:
•1. Documented evidence of plasma HIV-1 ribonucleic acid (RNA) persistently \<50 copies per millilitre (c/mL) ≤3 months prior to and at Screening. In the \>3 to 12 months prior to Screening, plasma HIV-1 RNA consistently \<50 c/mL required; if single increases ≥50 c/mL occurred, they cannot have been persistent nor associated with antiretroviral resistance per investigator assessment
•2. cluster of differentiation 4 (CD4) cell count \>350 cells per cubic millimetre (cells/mm\^3) over past 12 months and at Screening (and no measurement ≤350 cells/mm3 during that time period)
+7 more criteria

Exclusion Criteria

•Mixed lung carcinoma (small cell carcinoma and NSCLC), small cell carcinoma, large cell neuroendocrine carcinoma, sarcomatoid carcinoma, or any other histologies that would not benefit from anti-PD1 ± PBCD. If a potential participant has histology other than squamous cell or adenocarcinoma (e.g., mixed histology that is predominantly NSCLC, large cell without neuroendocrine features) but is deemed appropriate for treatment with anti-PD1 ± PBCD, they may be eligible pending discussion with the sponsor.
•For participants who received adjuvant therapy that included anti-PD(L)1 Checkpoint inhibitor (CPI) following surgical resection, their last dose of anti-PD(L)1 was \<6 months from the date of first 89Zr-durvalumab-PET tracer injection
•Participant has known central nervous system (CNS) metastases and/or carcinomatous meningitis that per investigator puts the participant at prohibitive risk to enrol in study
•Participant has a known additional malignancy that progressed or required active treatment within the last 2 years. Participant with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with assessments of the study may be included only after discussion with the Medical Monitor
•Participant is considered a poor medical risk by the investigator due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active infection requiring systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled chronic obstructive pulmonary disease; uncontrolled ventricular arrhythmia; recent (within 90 days) myocardial infarction; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent)
•Participant is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 150 days after the last dose of study treatment
•Participant has a diagnosed immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy that per investigator puts the participant at prohibitive risk to enrol in the study
•Participant has an active HIV infection that per investigator puts the participant at prohibitive risk to enrol in study
•Participant has tested positive for the presence of hepatitis B surface antigen and/or Hepatitis B virus (HBV) core antibody or has a positive hepatitis C antibody test result at Screening or within 3 months prior to first dose of anti-cancer treatment
•Participant has an active autoimmune disease that has required systemic treatment (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy up to 5 milligrams (mg) prednisone or equivalent for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Use of inhaled steroids, topical steroids, local injection of steroids, and steroid eye drops are allowed
+12 more criteria

Locations (1)

GSK Investigational Site

London, United Kingdom

Key Dates

Start Date

December 30, 2025

Primary Completion Date

August 7, 2028

Completion Date

October 10, 2029

Last Updated

February 3, 2026

Enrollment

ESTIMATED participants

Conditions

Lung Cancer, Non-Small Cell

Interventions

Pembrolizumab

BIOLOGICAL

Dostarlimab

BIOLOGICAL

Pemetrexed+ (carboplatin or cisplatin)

DRUG

Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

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