A clinical trial to compare atezolizumab plus tiragolumab with durvalumab in people with Stage III non-small cell lung cancer that cannot be removed by surgery (unresectable) and whose cancer has not gotten worse after chemoradiotherapy (SKYSCRAPER-03)

How does the SKYSCRAPER-03 clinical trial work?
This clinical trial is recruiting people who have a particular type of lung cancer called non-small cell lung cancer or NSCLC. In order to take part, patients must have NSCLC that is locally advanced (in the lung and lymph nodes in the middle of the chest), inoperable (cannot be removed by surgery) and have received at least two cycles of chemoradiotherapy without their disease worsening. 

The purpose of this clinical trial is to compare the effects, good or bad, of atezolizumab plus tiragolumab versus durvalumab alone in patients with NSCLC. In this clinical trial, you will get either atezolizumab plus tiragolumab or durvalumab alone.

How do I take part in this clinical trial?
To be able to take part in this clinical trial, you must be diagnosed with locally advanced, inoperable NSCLC and have received at least 2 cycles of chemoradiation without your cancer becoming worse. You must not have had any history of prior NSCLC or have tumours with a mutation in the epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) gene.

If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.

Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part. 

While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons. 

What treatment will I be given if I join this clinical trial?
Everyone who joins this clinical trial will be split into 2 groups randomly (like flipping a coin) and given either:

• tiragolumab plus atezolizumab, given as an infusion into the vein every 28 days for no more than 13 times (approximately 1 year)
• OR durvalumab, given as an infusion into the vein once every 2 weeks for no more than 26 times or every 4 weeks for no more than 13 times (approximately 1 year), depending on the dose you are given

You will have an equal chance of being placed in either group and will be told which group you are in. 

How often will I be seen in follow-up appointments and for how long?
You will be given the clinical trial treatment atezolizumab plus tiragolumab OR durvalumab for approximately 1 year. You are free to stop this treatment at any time. While receiving treatment, you will be seen regularly by the clinical trial staff every 2 weeks until you complete treatment, and then approximately every 3 months after that for up to 1 year. These hospital visits will include checks to see how you are responding to the treatment and any side effects that you may be having. After you stop receiving treatment, you will still be contacted regularly by the clinical trial staff at least every 3 months.

What happens if I am unable to take part in this clinical trial?
If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04513925

Trial-identifier: NCT04513925