A Study to Investigate Efficacy and Safety of Ceralasertib Plus Durvalumab in Participants Aged ≥… (NCT05941897) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study to Investigate Efficacy and Safety of Ceralasertib Plus Durvalumab in Participants Aged ≥ 18 Years With Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Progressed on or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy
Russia39 participantsStarted 2023-06-21
Plain-language summary
A study to investigate efficacy and safety of ceralasertib plus durvalumab in participants aged ≥ 18 years with advanced or metastatic non-small cell lung cancer whose disease progressed on or after prior anti-PD-(L)1 therapy and platinum-based chemotherapy.
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:
* Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.
* Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status.
* Documented radiological PD whilst on or after receiving the most recent treatment regimen.
* Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC.
* Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0 or 1.
* Adequate organ function and marrow reserve.
* Body weight \> 30 kg and no cancer-associated cachexia.
Exclusion Criteria:
* Participant with mixed SCLC and NSCLC histology.
* Brain metastases or spinal cord compression unless the participant is stable and off steroids.
* Persistent toxicities (CTCAE Grade \> 2) caused by previous anticancer therapy.
* Active or prior documented autoimmune or inflammatory disorders.
* History of leptomeningeal carcinomatosis.
* Participants who have received more than one line of prior anti-PD-(L)1.
* Participants must not have experienced a toxicity that led to discontinuation of the prior anti-PD(L)1 therapy.
* Participants must not have experienced a Grade ≥ 3 immune-mediated adverse event (imAE) or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD…
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 testing ceralasertib combined with durvalumab specifically for people whose NSCLC has already progressed after both immunotherapy and platinum-based chemotherapy — does my treatment history match that profile, and is this combination worth discussing for my situation?
2Since this is a Phase 2 trial measuring objective response rate, what does that mean for how much we currently know about whether this combination actually works and how safe it is compared to standard options?
3The trial is listed as 'active not recruiting,' which means they're no longer enrolling new patients — does that completely close the door, or are there related studies or expanded access programs using ceralasertib that might still be available to me?
4Given that my cancer has already progressed on prior immunotherapy, what would my doctor expect from adding ceralasertib — an ATR inhibitor — to durvalumab, and are there other combinations or trials targeting a similar mechanism that I should also be looking into?
5What are the potential side effects of combining an ATR inhibitor like ceralasertib with an immunotherapy drug like durvalumab, and how would managing those risks fit with my current health status and day-to-day life?
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
Objective response rate (ORR)
Timeframe: At month 6 after the last patient's first dose (approximately 18 months).