A phase III, randomised, double-blind, placebo-controlled, multicentre trial comparing efficacy and safety of trilaciclib versus placebo in participants with limited-stage small cell lung cancer
Small cell lung cancer is usually treated with chemotherapy and radiotherapy. While these treatments attack cancer cells, they can also damage healthy bone marrow. Bone marrow makes your blood cells, and when white blood cell levels drop too low, you are at a much higher risk of serious infections and severe tiredness. This Phase 3 clinical trial is investigating whether a medicine called trilaciclib can help shield bone marrow during chemotherapy. Participants will receive either trilaciclib or a dummy treatment (placebo) as an intravenous drip before their usual chemotherapy sessions. Neither you nor your doctor will know which one you receive. The research team will closely monitor your blood counts, hospital visits, and general wellbeing. Taking part is completely voluntary, and choosing to join or leave will not affect the standard of NHS care you receive.
At a glance
What is this study about?
Small cell lung cancer is a fast-growing type of lung cancer. When it is described as 'limited-stage', it means the cancer is located in one area of the chest and can be treated within a single radiotherapy field. The standard treatment usually involves a combination of chemotherapy drugs and radiotherapy. While chemotherapy is effective at killing cancer cells, it also damages healthy, fast-growing cells in your bone marrow.
Your bone marrow produces red blood cells, platelets, and white blood cells (especially neutrophils, which fight infection). When chemotherapy causes these cell counts to plummet, patients can experience severe fatigue, bleeding, or dangerous infections. Doctors often have to delay chemotherapy doses or reduce the strength of treatment, which can make cancer care less effective.
This trial is testing an experimental medicine called trilaciclib. Trilaciclib is designed to give healthy bone marrow cells a temporary 'pause' just before chemotherapy is given, protecting them from damage. Researchers hope this will keep blood counts healthier, prevent serious infections, and allow patients to finish their cancer treatment on schedule.
Because this is a Phase 3 trial, researchers are comparing trilaciclib directly against a placebo (an inactive drip) to confirm whether it truly makes a difference. Participants will be monitored carefully throughout their chemotherapy cycles to see how their blood counts respond and how their overall quality of life is affected.
Key takeaways
- Tests whether the drug trilaciclib protects bone marrow during lung cancer treatment.
- Open to adults aged 18 and older with limited-stage small cell lung cancer.
- Given as an intravenous drip alongside standard chemotherapy and radiotherapy.
- Half of the participants receive trilaciclib and half receive a dummy drip (placebo).
- Requires regular blood tests to check your infection-fighting white blood cells.
- Participation is entirely voluntary and standard care continues regardless.
Who may be eligible?
This trial is open to adults aged 18 and over who have been diagnosed with limited-stage small cell lung cancer and are scheduled to receive standard chemotherapy.
To be eligible, participants need to be well enough to undergo regular cancer treatment. Doctors will check that your vital organs, such as your kidneys, liver, and heart, are working well enough for you to take part safely.
You might not be able to take part if you have certain other active medical conditions, severe ongoing infections, or if you have already received extensive previous treatments that could interfere with the study results. Your cancer specialist will go through the full medical checklist with you to confirm if this study is suitable.
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.
- I am at least 18 years old.
- I have been diagnosed with limited-stage small cell lung cancer.
- I am due to start chemotherapy treatment.
- I am well enough to attend regular clinic visits and blood tests.
- I am willing to complete surveys about my symptoms and wellbeing.
What does participation involve?
If you take part, you will receive either trilaciclib or a placebo as a drip into a vein shortly before your scheduled chemotherapy treatments. Because trilaciclib has a pale yellow colour, special covers or tubing may be used so that neither you nor your clinical team knows which treatment you are receiving.
You will need to attend hospital for your planned chemotherapy and radiotherapy visits, along with extra visits for blood tests. In the first few treatment cycles, blood tests are done frequently to monitor your white blood cell levels. You will also be asked to complete short questionnaires about your energy levels, symptoms, and daily quality of life.
Your involvement will last throughout your chemotherapy cycles (usually around four cycles, lasting several months) followed by a check-up approximately 90 days after treatment finishes.
Potential risks and benefits
Locations (7)
- —UnverifiedCzechia
- —UnverifiedGreece
- —UnverifiedFrance
- —UnverifiedBelgium
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedGermany
Common questions
What does 'limited-stage' small cell lung cancer mean?
It means the cancer is contained within one side of the chest and nearby lymph nodes, so it can be treated safely with radiotherapy in one targeted area.
Will I still get my normal cancer treatment?
Yes. All participants receive standard chemotherapy and radiotherapy. The trial medicine (or placebo) is given alongside your usual treatment, not instead of it.
What is a placebo and why is it used?
A placebo is a harmless dummy treatment that looks just like the trial medicine. It helps researchers prove whether any improvements are truly caused by the new drug rather than chance.
What is neutropenia?
Neutropenia is a drop in a specific type of white blood cell called neutrophils. These cells help your body fight bacterial infections, so having low levels puts you at greater risk of becoming unwell.
Can I leave the trial if I change my mind?
Yes, you can leave the study at any time. Your decision will never affect your relationship with your medical team or the quality of your NHS care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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