A Phase III Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy

To join this study, your doctor will first need to check if you meet certain criteria. You must have advanced non-small cell lung cancer that has been confirmed by tests when examined in a lab. Your cancer also needs to have grown or spread after your most recent treatment, and you must have already received both an immunotherapy (anti-PD-(L)1) and a platinum-based chemotherapy for your advanced lung cancer. It's also important that tests of your cancer show it doesn't have certain gene changes (EGFR or ALK mutations) which are usually treated with different targeted therapies.

Your general health also plays a role. You should be able to manage most of your daily activities without much help, have your organs (like your liver and kidneys) working well, and weigh more than 30 kg (about 4 stone 10 pounds). For women who could become pregnant, a negative pregnancy test is required. The study is open to both men and women aged 18 and over, with no upper age limit.

There are also reasons why you might not be able to join. For example, if you have a mix of small cell and non-small cell lung cancer, or if you've had another type of cancer recently that hasn't been completely cured. If you have active autoimmune conditions (where your body attacks itself), or if previous cancer treatments left you with lasting severe side effects (Grade 3 or higher immune-related side effects from previous immunotherapy), you might not be eligible. Also, if you needed strong medications (like steroids) for side effects from previous immunotherapy, this study might not be suitable.

If you join this study, you will be assigned by chance to one of two groups. One group will receive the new combination of ceralasertib and durvalumab. Ceralasertib is a pill you'll take, and durvalumab is given through a drip into your vein. The other group will receive docetaxel, which is also given through a drip into your vein.

Your treatment cycles will vary slightly depending on your group: either 28-day cycles for the combination therapy or 21-day cycles for docetaxel. You will have regular hospital visits, likely every few weeks, for your treatments, blood tests, and check-ups. These check-ups will monitor your health, look for any side effects, and see how your cancer is responding to the treatment. You'll have scans (like CT scans) periodically to track your cancer's progress. Your participation will continue as long as the treatment is helping you and side effects are manageable, or until the study ends. After stopping the study treatment, there will be follow-up appointments or phone calls to monitor your health and overall well-being. The total duration of your involvement could be several months or even longer, depending on your response to treatment and the study's timeline.