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), Cisplatin (drug), Carboplatin (drug), Pemetrexed (drug)
- How long the study runs
- Study runs about 159 months (dates as stated)
- About the drug or intervention
- Pembrolizumab — biological: IV Infusion · Cisplatin — drug: IV infusion · Carboplatin — drug: IV infusion · Pemetrexed — drug: IV infusion · Gemcitabine — drug: IV infusion · Paclitaxel — drug: IV infusion · Intismeran autogene — biological: IM injection · Placebo — other: IM injection
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 680
- Started
- 2024-10-21
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for carcinoma, non-small-cell lung
- • Phase3 - 680 participants
- • The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with carcinoma, non-small-cell lung
Where?
- • Bristol - Bristol Haematology and Oncology Centre ( Site 2072)
- • London - ROYAL MARSDEN HOSPITAL (CHELSEA)-Lung Unit ( Site 2075)
- • London - St Bartholomews Hospital ( Site 2052)
- • London - Royal Free Hospital ( Site 2074)
- • +8 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).
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: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ well controlled HIV on anti-retroviral therapy (ART)
What the study is looking for
- ✓The main inclusion criteria include but are not limited to the following:
- ✓Has an activity scale (ECOG) performance status of 0 or 1 within 7 days before the first dose of...
- ✓Participants who have not achieved a pathological complete response (pCR) following completion of before surgery...
- ✓Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy...
- ✓Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)
Who cannot take part
- ✗The main exclusion criteria include but are not limited to the following:
- ✗Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
- ✗Received prior before surgery therapy for their current NSCLC diagnosis
- ✗Received prior systemic anticancer therapy including investigational agents other than what is specified in this...
- ✗Received prior treatment with a cancer vaccine
See the full criteria
Where Is This Study? (12 UK sites)
Bristol Haematology and Oncology Centre ( Site 2072)
Bristol BS2 8ED, United Kingdom
ROYAL MARSDEN HOSPITAL (CHELSEA)-Lung Unit ( Site 2075)
London SW3 6JJ, United Kingdom
St Bartholomews Hospital ( Site 2052)
London EC1A 7BE, United Kingdom
Royal Free Hospital ( Site 2074)
London NW3 2QG, United Kingdom
Guys Hospital ( Site 2057)
London SE1 3SS, United Kingdom
Royal Marsden Hospital (Sutton) ( Site 2076)
London SW3 6JJ, United Kingdom
Nottingham City Hospital ( Site 2058)
Nottingham NG5 1PB, United Kingdom
St James University Hospital ( Site 2055)
Leeds LS9 7TF, United Kingdom
Leicester Royal Infirmary ( Site 2051)
Leicester LE1 5WW, United Kingdom
The Christie NHS Foundation Trust ( Site 2066)
Manchester M20 4BX, United Kingdom
The Clatterbridge Cancer Centre ( Site 2069)
Metropolitan Borough of Wirral CH63 4JY, United Kingdom
Queen Alexandra Hospital ( Site 2059)
Portsmouth PO6 3LY, United Kingdom
How to Get in Touch
Toll Free Number
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