AuthorisedTherapeutic confirmatory (Phase III)Interventional

IFEM – Pembrolizumab monotherapy versus pembrolizumab in combination with chemotherapy as first line therapy in females with advanced Non-small cell lung cancer (NSCLC) & PD-L1 expression ≥ 50%

This phase 3 clinical trial is designed for women who have newly diagnosed, advanced non-small cell lung cancer (NSCLC). Doctors want to find out whether giving an immunotherapy drug called pembrolizumab by itself works just as well as, or better than, combining it with chemotherapy. Pembrolizumab helps the body's natural immune system find and attack cancer cells. In this trial, researchers are specifically looking at female patients whose tumours have high levels of a protein called PD-L1 (50% or higher). Previous research suggests women's immune systems might respond differently to these treatments. Participants will be placed into one of two groups: one receiving pembrolizumab alone, and the other receiving pembrolizumab alongside chemotherapy. The study will track how long the treatment keeps the cancer from growing, overall wellbeing, and any side effects.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Deutsches Krebsforschungszentrum Stiftung Des Oeffentlichen Rechts

Enrolment target

406

Start

08 Oct 2026

Advanced non‑small cell lung cancer (NSCLC)

What is this study about?

Non-small cell lung cancer is the most common form of lung cancer. When it is advanced, finding the most effective initial treatment is crucial. In recent years, immunotherapy has changed how doctors treat this condition. Instead of attacking cancer cells directly like chemotherapy, immunotherapy trains your own immune system to recognise and fight the cancer. Pembrolizumab is one such immunotherapy medicine.

Currently, people with high levels of a protein called PD-L1 on their cancer cells can receive pembrolizumab on its own or together with chemotherapy. However, men and women often have subtle differences in how their immune systems work and how they process cancer drugs. Most past trials looked at men and women together, meaning we do not yet know for sure which approach gives women the best balance of tumour control and quality of life.

This trial aims to answer that question specifically for women. By comparing pembrolizumab alone directly against pembrolizumab mixed with chemotherapy, researchers hope to discover if women can achieve the same or better results without needing the extra burden and side effects of chemotherapy drugs.

Key takeaways

A phase 3 study comparing pembrolizumab alone against pembrolizumab plus chemotherapy.
Open exclusively to adult women with advanced non-small cell lung cancer.
Tumours must show high levels of the PD-L1 protein (50% or higher).
Aims to find out if women can avoid chemotherapy while keeping the same cancer-fighting benefits.
Participation is entirely voluntary and you can stop at any time.

Who may be eligible?

This trial is specifically for adult women aged 18 and older who have been diagnosed with advanced non-small cell lung cancer. To be eligible, you must not have had any previous systemic treatment (such as chemotherapy or targeted therapy) for this advanced stage of your cancer.

Your tumour will also need to be tested for a specific marker called PD-L1. You can only join if the test shows that at least 50% of your cancer cells express this protein, as pembrolizumab is known to work best in tumours with high PD-L1 levels.

As with most trials, you will need to be well enough to carry out everyday activities, and your vital organs (like your heart, kidneys, and liver) must be working reasonably well. People with certain active autoimmune conditions or other serious illnesses may not be able to participate safely.

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 a woman aged 18 or older.
I have been diagnosed with advanced non-small cell lung cancer.
I have not yet started treatment for this advanced stage of cancer.
My tumour has tested positive for high levels of PD-L1 (50% or higher), or my doctor can test for this.
I am generally well enough to manage my day-to-day self-care and attend hospital visits.

Answer every question to see your result.

What does participation involve?

If you take part, you will be assigned by chance (randomised) to one of two treatment groups. One group receives pembrolizumab alone, given through an intravenous drip in your vein at the hospital once every few weeks. The other group receives pembrolizumab along with standard chemotherapy drips (such as pemetrexed, paclitaxel, carboplatin, or cisplatin).

You will need to visit the hospital regularly for your infusions, blood tests, and health checks. Every few months, you will have CT or MRI scans to see how your tumour is responding. You will also be asked to fill in brief questionnaires about your daily quality of life and any symptoms you feel.

Treatment usually continues for up to two years, as long as the medicine is controlling the cancer and you are not having troublesome side effects. After treatment finishes, the research team will keep in touch with you periodically to monitor your ongoing health.

Potential risks and benefits

Taking part may help slow down or shrink your cancer, and you will be closely monitored by a team of cancer specialists. The results will also help doctors choose better, more tailored treatments for women with lung cancer in the future. However, there are potential risks. Both immunotherapy and chemotherapy carry side effects, which may include tiredness, nausea, hair thinning, infections, or inflammation of healthy organs. Chemotherapy tends to cause more frequent side effects than immunotherapy alone. Taking part is completely your choice, and you are free to leave the trial at any point without it affecting your standard NHS care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

Why is this trial only open to women?

Research shows that biological sex can influence how the immune system behaves. This trial is specifically designed to understand how women respond to these treatments so doctors can provide more personalised care.

Can I choose which treatment group I join?

No. A computer places you into a treatment group at random. This makes sure the comparison between the two treatments is fair and reliable.

What is PD-L1 and how do I know if I have it?

PD-L1 is a protein found on the surface of some cancer cells. Your doctor checks for it by testing a small sample of tissue (biopsy) that was taken when you were diagnosed.

Will taking part cost me anything?

No. The trial medicines and tests are provided free of charge, and many hospital research units help cover travel expenses for trial-related visits.

What happens if my cancer gets worse during the study?

Your medical team monitors you closely with regular scans. If the cancer grows or the treatment stops helping, the study team will stop the trial drug and discuss alternative treatment options with you.