I4C-MC-JTBB: A Randomized, Controlled Phase 2 Study Evaluating LY2875358 plus Erlotinib versus Erlotinib as First-Line Treatment in Metastatic NSLC Patients with Activating EGFR Mutations Who Have Disease Control after an 8-Week Lead-In Treatment with Erlotinib
This research study is investigating a new treatment approach for adults with metastatic non-small cell lung cancer. This is a type of lung cancer that has spread to other parts of the body and has a particular genetic change called an EGFR mutation. The study will test a new drug, LY2875358, given alongside an established treatment called erlotinib. Some patients will receive this new combination, while others will receive erlotinib on its own. Researchers want to find out if the new combination can help patients live longer without their cancer getting worse, compared to erlotinib alone. Participants would have already shown some improvement or stability after starting erlotinib before joining the main part of the study. This is a Phase 2 study, meaning it's still in the earlier stages of testing new treatments.
At a glance
What is this study about?
This study is for people in the UK who have a type of advanced lung cancer called non-small cell lung cancer. Specifically, it's for those whose cancer has spread to other parts of the body (metastatic) and has a particular change in their genes called an EGFR mutation. This mutation can make certain lung cancers grow.
Researchers are looking into whether a new drug, called LY2875358, when given together with an existing treatment, erlotinib, can work better than erlotinib alone. Erlotinib is a treatment that helps to slow down or stop the growth of cancer cells, especially in people with this specific EGFR mutation. The aim is to see if combining these two drugs can help patients live longer without their cancer getting worse. This is an important step in finding potentially more effective ways to treat this type of lung cancer.
Before joining the main part of this study, all potential participants will first be given erlotinib for eight weeks. Only those whose cancer has been controlled or improved during these eight weeks will then be able to join the main study. This helps researchers focus on patients who are likely to benefit from the erlotinib treatment, and then see if adding the new drug makes an even bigger difference in keeping the cancer under control.
Key takeaways
- Tests a new drug with existing treatment for advanced non-small cell lung cancer.
- Specifically for patients with an EGFR genetic mutation.
- Participants must show a good response to erlotinib first.
- Compares combination therapy to erlotinib alone.
- Aims to see if the new combination can slow cancer growth longer.
Who may be eligible?
To be considered for this study, you need to be an adult, at least 18 years old, with metastatic non-small cell lung cancer. Your cancer must also have a specific genetic change called an EGFR mutation.
An important first step is that you would receive erlotinib, one of the study drugs, for about eight weeks. During this time, doctors will check how your cancer responds. Only if your cancer is stable or has improved after these eight weeks would you then be able to continue and be included in the main part of the study.
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.
- Are you 18 years old or older?
- Do you have non-small cell lung cancer that has spread (metastatic)?
- Does your cancer have an EGFR genetic mutation?
- Are you willing to take erlotinib for 8 weeks first to see how your cancer responds?
What does participation involve?
If you decide to take part in this study, you would first receive a standard lung cancer treatment called erlotinib for about eight weeks. During this time, doctors would regularly check how your cancer is responding. If your cancer is stable or has improved, you would then be randomly assigned to one of two groups. One group would continue to receive erlotinib along with the new investigational drug, LY2875358. The other group would receive erlotinib only. You wouldn't choose which group you're in, it's decided by chance, like flipping a coin.
Throughout the study, you would have regular hospital visits for check-ups, blood tests, and scans (like X-rays or CT scans) to monitor your health and how your cancer is responding to treatment. This would involve taking the study medications as prescribed. The total time you spend in the study would depend on how well the treatment works for you and your health. There would also be follow-up appointments after you stop taking the study medication to keep an eye on your health.
Potential risks and benefits
Locations (2)
- —UnverifiedSpain
- —UnverifiedGermany
Common questions
What kind of lung cancer is this study for?
It's for non-small cell lung cancer that has spread (metastatic) and has a specific genetic change called an EGFR mutation.
What are the treatments being tested?
The study compares a new drug called LY2875358 combined with erlotinib, versus erlotinib on its own.
Who can join the study?
Adults aged 18 or over whose cancer has an EGFR mutation and has responded well to an initial 8 weeks of erlotinib treatment.
What does 'Phase 2' mean?
It means this is an earlier stage of testing, to see if the new drug combination is safe and shows promise for treating the cancer.
Will I definitely get the new drug?
If you join the main part of the study, you will be randomly assigned to either receive the new drug with erlotinib or erlotinib alone.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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