Testing the Addition of AZD6738 (Ceralasertib) to Immunotherapy to Increase Time Without Cancer f… (NCT06732401) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Testing the Addition of AZD6738 (Ceralasertib) to Immunotherapy to Increase Time Without Cancer for Patients With Non-Small Cell Lung Cancer
United States630 participantsStarted 2025-08-07
Plain-language summary
This phase III trial compares the effect of adding AZD6738 to durvalumab versus durvalumab alone to increase time without cancer in patients with non-small cell lung cancer, following treatment with chemotherapy and surgery. AZD6738 may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Adding AZD6738 to durvalumab may increase time without cancer in patients with non-small cell lung cancer, following treatment with chemotherapy and surgery.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* STEP 0: Patient must be \>= 18 years of age
* STEP 0: Patient must have stage II to select stage IIIB (N2 but excluding N3) non-small cell lung cancer (NSCLC) of any histology using International Association for the Study of Lung Cancer (IASLC) 8th edition. Stage is assessed at time of initiating pre-operative chemo-immunotherapy
* STEP 0: Patient must fall into one of the following categories:
* Planning to undergo, be currently undergoing, or recently completed any standard of care neoadjuvant chemo-immunotherapy with plans to undergo surgical resection
* Recently completed any standard of care neoadjuvant chemo-immunotherapy AND completed surgical resection and are awaiting pCR status.
* Recently completed any standard of care neoadjuvant chemo-immunotherapy AND completed surgical resection with confirmed non-path complete response (CR) status.
NOTES:
* Patient must have completed at least 3 cycles of neoadjuvant chemo-immunotherapy before surgery in order to be eligible for Step 1 randomization.
* Patients who have completed their surgical resection prior to enrollment in step 0 registration must have their surgery date within a window that will allow initiation of EA5231 treatment (cycle 1 day 1) to commence within 4-12 weeks following surgery
* STEP 1: EA5231 CLEAR randomization for patients without a pCR post-surgery. Patient's with pCR after surgery will be offered to enroll in the SWOG study S2414 INSIGHT instead
* STEP 1: Patient…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is adding ceralasertib (AZD6738) on top of immunotherapy for Stage II–IIIB non-small cell lung cancer — how does combining an ATR inhibitor with immunotherapy change the side effect picture compared to immunotherapy alone, and would my current health make those risks more or less manageable?
2Since this is a Phase 3 trial measuring disease-free survival, what does the existing evidence on ceralasertib suggest about whether it might actually extend the time before cancer comes back, and how does that compare to what standard treatment after surgery or chemoradiation already offers me?
3The trial is listed as active but no longer recruiting — does that mean enrollment is closed, and if so, are there any similar trials or expanded access options you'd recommend I look into instead?
4Given that my cancer is Stage II or Stage III, would you say my situation aligns with what this trial was designed for, or is there a standard-of-care pathway you'd want me to try first before considering an investigational combination like this?
5What would the practical demands of this trial look like for someone in my situation — how often are visits, how long does treatment last, and how would participating affect my ability to continue work or caregiving responsibilities?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disease free survival (DFS)
Timeframe: From randomization to the earliest event defined as the first recurrence of non-small cell lung cancer (NSCLC), any new lung cancer or death, up to 10 years