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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (1 UK site)
GSK Investigational Site
London SE1 9RT, United Kingdom
