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Study stopped earlyPhase1/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)

Sponsor: GlaxoSmithKline

NCT ID: NCT06405230

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Pembrolizumab (biological), Dostarlimab (biological), Pemetrexed+ (carboplatin or cisplatin) (drug)
How long the study runs
Study runs about 9 months (dates as stated)
About the drug or intervention
Pembrolizumab — biological: Pembrolizumab will be administered. · Dostarlimab — biological: Dostarlimab will be administered. · Pemetrexed+ (carboplatin or cisplatin) — drug: PBCD consisting of pemetrexed+ (carboplatin or cisplatin) will be administered.
Patient visit burden
Not specified by the sponsor

In plain English

This study looks at non-small cell lung cancer (a common type of lung cancer) that has come back or spread after earlier surgery to remove the tumour. Researchers are studying how a protein called PD-L1 responds to treatment, using blood samples containing tiny particles released by cells, miniature lab-grown copies of the patient's tumour, and a special type of scan called a positron emission tomography (PET) scan.

Who can take part

  • Adults whose non-small cell lung cancer has come back or spread after surgery for early-stage (Stage 1-3) disease, confirmed by a biopsy
  • The cancer's PD-L1 status must already be known before joining
  • At least one tumour that can be measured on a CT or MRI scan (unless it was previously treated with radiotherapy)
  • Fit enough to receive first-line treatment with an immunotherapy drug (anti-PD1), with or without chemotherapy, and able to carry out daily activities with little or some help (performance status 0 to 2)
  • Tissue must have been submitted to try to grow a miniature lab-grown copy of the tumour
  • A fresh tumour biopsy taken during checks for the cancer's return, if this is safe and possible; if not, a stored sample can be used
  • Good enough organ function, in the doctor's view
  • People with controlled HIV can take part if their infection is well controlled on stable treatment, with a good CD4 (a type of immune cell) count and a very low amount of virus in the blood
  • Fully recovered from any side effects of previous surgery

Who may not be able to

  • Cancers that are partly or fully small cell type, or other rare types unlikely to benefit from this immunotherapy (some exceptions may be discussed with the sponsor)
  • Anti-PD(L)1 immunotherapy within 6 months before the first PET scan injection (for those who had it after surgery)
  • Cancer spread to the brain or the lining of the brain that the doctor believes makes joining too risky
  • Another cancer that needed treatment or got worse in the last 2 years
  • Serious uncontrolled health problems, such as severe lung disease, recent heart attack (within 90 days), uncontrolled seizures, or serious mental health or substance problems that would affect taking part
  • Pregnancy, breastfeeding, or planning to become pregnant during the study and for 150 days after the last dose of treatment
  • Use of medicines that weaken the immune system, such as high-dose steroids (some replacement therapies and inhaled, skin or eye steroids are allowed)
  • Hepatitis B or hepatitis C infection shown by positive test results
  • An autoimmune disease needing body-wide treatment
  • History of lung scarring or lung inflammation, or signs of active lung inflammation on the screening chest scan
  • Taking part in another study drug or device trial within the last 4 weeks
  • Serious liver disease such as cirrhosis with complications
  • Any anti-cancer treatment (chemotherapy, radiotherapy, immunotherapy) for the returned cancer after the first surgery
  • Lung cancers with certain gene changes (EGFR, ALK or ROS1)
  • Severe allergic reactions to antibodies or to the study drugs pembrolizumab, dostarlimab, durvalumab or their ingredients
  • Shingles with symptoms within 3 months before screening
  • Active or latent tuberculosis (TB)
  • A heart rhythm measure (QTc) above 450 milliseconds, or above 480 milliseconds with bundle branch block
  • Certain vaccines within 7 days (or 30 days for some COVID-19 vaccines) of starting treatment

What taking part involves

  • • Not stated — ask the trial team exactly which treatments participants receive
  • • The study involves at least one PET scan injection with a radioactive tracer called 89Zr-durvalumab
  • • Blood tests to study tiny particles released by cells (extracellular vesicles)
  • • Growing a miniature copy of the patient's tumour in the laboratory from their tissue (patient-derived organoids)
  • • The eligibility criteria mention first-line treatment with an immunotherapy (anti-PD1), with or without chemotherapy

Time commitment: Not stated — ask the trial team. Taking part involves a fresh tumour biopsy (if safe), blood tests, PET scans, and study treatment; details of visit numbers and study length are not given.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
30 Years and over
Who
All
Number of participants
2
Started
2025-10-10
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for lung cancer, non-small cell
  • • Phase1/Phase2 - 2 participants
  • • 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

Who can take part?

  • • Ages 30 Years and over
  • • Diagnosed with lung cancer, non-small cell

Where?

  • • London - GSK Investigational Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Lung Cancer, Non-Small Cell

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 30 Years and over
  • Who can join: All genders

Biomarkers mentioned

PDL1CD4tested positivehas a positiveEGFRALKROS1either a positive

Treatment history

Treatments you must have had:

  • ✓ biopsy-confirmed recurrence of their initial NSCLC with advanced/metastatic presentation
  • ✓ had tissue submitted for attempted PDO generation

What the study is looking for

  • ✓Participants must have histologically- or cytologically documented NSCLC who present with recurrent advanced or...
  • ✓Participants must have been initially diagnosed with operable Stage 1-3 NSCLC and received curative resection ±...
  • ✓Identifiable PDL1 status prior to randomisation
  • ✓Participants must have biopsy-confirmed recurrence of their initial NSCLC with advanced/that has spread presentation
  • ✓Participants must be deemed by investigator to be appropriate to receive 1L treatment that goes through your whole body (i.e., anti-PD1 ± PBCD)

Who cannot take part

  • ✗Participant has known central nervous system (CNS) metastases and/or carcinomatous meningitis that per investigator...
  • ✗Participant has an active HIV infection that per investigator puts the participant at prohibitive risk to enrol in study
  • ✗Participant has not recovered adequately (≤ Grade 1) per investigator from AEs and/or complications from any major...
  • ✗Participant has received any form of anti-cancer therapy (e.g., drug treatment, radiation, treatment that helps your immune system fight cancer) for lung...
  • ✗causing symptoms herpes zoster within 3 months prior to screening
See the full criteria
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) 3. Must be on an uninterrupted combination antiretroviral therapy regimen for at least 3 months prior to Screening, with combination antiretroviral therapy regimen consistent with locally recommended guidelines 4. Participants with history of Centres for Disease Control and Prevention (CDC) Stage 3 acquired immunodeficiency syndrome (AIDS)-defining disease are allowed if AIDS-defining disease has been treated and cured or is stable for ≥3 months prior to study entry. Cutaneous Kaposi's sarcoma not requiring systemic therapy is allowed 5. No history of HIV-associated non-Hodgkin lymphoma ≤5 years prior to study entry 6. No treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening * Fresh tumour biopsy (taken as part of disease recurrence evaluation) is a requirement, provided that a biopsy procedure is technically feasible and the procedure is not associated with unacceptable clinical risk. If fresh biopsy sample is not available, an archival sample may be used * Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 * Has adequate organ function per the investigator 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 * Participant has history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan that per investigator and medical monitor puts the participant at prohibitive risk to enrol in study * Participant is currently participating and receiving study therapy or has participated in a study of an investigational agent and received investigational therapy or used an investigational device within 4 weeks prior to the first dose of study drug * Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal/gastric varices, or persistent jaundice * Participant has not recovered adequately (≤ Grade 1) per investigator from AEs and/or complications from any major surgery prior to starting therapy * Participant has received a vaccine other than a vaccine against Severe acute respiratory syndrome coronavirus disease 19 (SARS-CoV-2) infection (COVID-19) within 7 days of planned start of study therapy. The use of all COVID-19 vaccines is allowed, with the exception of COVID-19 vaccines using the recombinant adenoviral vector platform within 30 days of planned start of study therapy. If a COVID-19 vaccine using this platform is to be administered within 30 days of planned start of study therapy, this must first be discussed with and approved by the sponsor's medical monitor * Participant has received any form of anti-cancer therapy (e.g., chemotherapy, radiation, immunotherapy) for lung cancer recurrence after initial surgery * Is receiving any additional anticancer post-surgery±(neo) adjuvant therapy or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention * NSCLC with known sensitizing EGFR mutations, Anaplastic lymphoma kinase (ALK) translocations, or c-ros oncogene 1 (ROS1) mutations from resected tissue at the time of initially surgery and/or tissue biopsy at the time of screening * Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to pembrolizumab, dostarlimab, durvalumab, or their excipients * Symptomatic herpes zoster within 3 months prior to screening * Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and TB testing: either a positive Tuberculin skin test (TST) (defined as a skin induration ≥5 millimetres \[mm\] at 48 to 72 hours, regardless of Bacillus Calmette-Guerin or other vaccination history) or a positive (not indeterminate) TB test such as QuantiFERON-TB Gold Plus test * QT interval corrected for heart rate according to Fridericia's formula (QTc) \>450 milliseconds (msec) or QTc \>480 msec in participants with bundle branch block

Where Is This Study? (1 UK site)

GSK Investigational Site

London SE1 9RT, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-08