A Phase I-II, Multicenter Study Evaluating the Efficacy and Safety of Multiple Therapies in Cohorts of Patients with Resectable Stage I-III Non-Small Cell Lung Cancer, selected according to Biomarker Status
This clinical trial is looking at new ways to treat non-small cell lung cancer (stages 1 to 3) before surgery takes place. Doctors call treatment given before surgery 'neoadjuvant' therapy. In this study, treatments are tailored to the patient based on specific biological markers (biomarkers) found in their tumour cells. Participants receive either standard chemotherapy drips (such as cisplatin, carboplatin, or pemetrexed) or targeted therapy tablets (such as alectinib) designed to attack specific cancer pathways. The main goal is to find out if these medicines are safe and whether they can clear or shrink the tumour before an operation. Doctors will monitor side effects closely and check the removed tissue after surgery to see how many cancer cells were destroyed. The study aims to improve long-term outcomes and help stop the cancer from returning.
At a glance
What is this study about?
When lung cancer is found early (stages 1 to 3), the main goal is often to remove the tumour with surgery. However, doctors are always looking for ways to reduce the chance of the cancer coming back. One promising approach is giving medical treatment before the operation. This can help shrink the tumour, making it easier to remove, and may destroy tiny cancer cells that have started to spread elsewhere in the body.
Every person's cancer has unique biological traits, known as biomarkers. In this trial, doctors test the tumour's genes and proteins to choose the treatment most likely to work. Depending on these results, patients receive targeted therapy tablets such as alectinib, or combinations of standard chemotherapy drugs like cisplatin, carboplatin, and pemetrexed.
Researchers will closely monitor how patients cope with the treatment before their operation. They want to check whether the medicines cause manageable side effects and ensure that surgery is not delayed. After the operation, specialists will examine the removed tumour under a microscope to see if any living cancer cells remain.
By testing this personalised approach, the trial hopes to find safer, more effective ways to prepare patients for lung cancer surgery, ultimately giving them the best possible chance of staying cancer-free in the long term.
Key takeaways
- Tests cancer treatment given before surgery for stage 1 to 3 non-small cell lung cancer.
- Matches treatment to the specific genetic features (biomarkers) of your tumour.
- Uses targeted tablets (alectinib) or standard chemotherapy drips.
- Aims to safely shrink tumours and reduce the risk of cancer returning.
- Open to adults aged 18 and over who are medically fit for surgery.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with non-small cell lung cancer that has not spread widely (stages 1, 2, or 3). Crucially, the cancer must be considered 'resectable', meaning a surgeon believes the tumour can be completely removed with an operation.
To take part, your tumour tissue will need to be tested for specific biomarkers. These tests show whether your cancer has the particular biological targets that match the study medicines, such as the targeted drug alectinib.
Because the study involves strong medicines and an operation, participants need to be in good general health. Your doctor will check that your heart, kidneys, liver, and lungs are working well enough to safely handle chemotherapy and surgery.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- You are aged 18 or older.
- You have been diagnosed with stage 1, 2, or 3 non-small cell lung cancer.
- A surgeon has confirmed that your lung tumour can be surgically removed.
- Your tumour tissue can be tested for specific study biomarkers.
- You are well enough to undergo both cancer drug treatment and an operation.
What does participation involve?
If you take part, your care will be planned around several key stages. First, you will have screening tests, including blood work, heart traces (ECGs), and imaging scans (such as CT or PET scans) to confirm your eligibility. You will then receive your assigned treatment over several weeks before your operation. Chemotherapy is usually given as an infusion through a drip in a hospital day unit, while targeted drugs like alectinib are taken at home as daily capsules.
During treatment, you will attend regular hospital appointments so the team can monitor your health and manage any side effects. Once this phase is complete, you will have your planned surgery to remove the tumour. After the operation, you will have follow-up visits and regular scans for several months or years so doctors can track your recovery and long-term health.
Potential risks and benefits
Locations (8)
- —UnverifiedFrance
- —UnverifiedNetherlands
- —UnverifiedBelgium
- —UnverifiedDenmark
- —UnverifiedItaly
- —UnverifiedAustria
- —UnverifiedPoland
- —UnverifiedSpain
Common questions
Will taking part delay my planned surgery?
The trial is designed so that treatment happens before surgery within a planned timeline. Doctors will monitor you closely to make sure the operation happens as close to schedule as possible, provided you are well enough.
What is a biomarker?
A biomarker is a biological feature or genetic change found inside cancer cells. Testing for biomarkers helps doctors understand how the cancer behaves and choose medicines that specifically target those weaknesses.
Do I have to pay to take part in this clinical trial?
No. In the UK, clinical trial medicines and study-related tests are provided free of charge, usually through the NHS hospital running the trial.
What happens if I experience difficult side effects?
Your care team will support you with medications to relieve side effects, such as anti-sickness tablets. If side effects become too severe, your doctor may adjust your dose, pause the medicine, or stop the study treatment.
Can I change my mind after joining the study?
Yes, taking part is completely voluntary. You are free to withdraw from the trial at any point, and your normal cancer care and surgical plans will continue as standard.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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