Phase III Study Comparing Ceralasertib and Durvalumab with Docetaxel in Non-Small Cell Lung Cancer Patients After Previous Treatments
Sponsor: AstraZeneca
ClinicalTrials ID:NCT05450692
This clinical trial is testing a new combination of drugs, ceralasertib and durvalumab, against the standard treatment, docetaxel, in patients with advanced non-small cell lung cancer (NSCLC) whose disease has worsened after previous therapies.
Patient Parameters
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Program Overview
The study aims to evaluate how effective and safe the combination of ceralasertib and durvalumab is compared to the standard treatment, docetaxel, in patients with advanced non-small cell lung cancer (NSCLC) that has progressed after receiving anti-PD-(L)1 therapy and platinum-based chemotherapy.
Description
This study involves two groups of treatment:
- Group A: Patients will receive a combination of ceralasertib and durvalumab. Ceralasertib is taken orally, and durvalumab is given through an IV. This treatment cycle lasts 28 days.
- Group B: Patients will receive docetaxel alone, administered through an IV. This treatment cycle lasts 21 days.
Participants will be randomly assigned to one of these two groups to compare the effectiveness and safety of the treatments.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC).
- Have specific genetic markers (EGFR and ALK wild-type) as confirmed by a local lab.
- Cancer must have worsened after the most recent treatment.
- Eligible for second or third-line therapy and must have previously received anti-PD-(L)1 therapy and platinum-based chemotherapy.
- Be in good general health with a performance status of 0 or 1.
- Have adequate organ function and bone marrow reserves.
- Have a life expectancy of at least 12 weeks.
- Weigh more than 30 kg and not have severe weight loss due to cancer.
- Women of childbearing potential must have a negative pregnancy test.
Exclusion Criteria
- Have a mix of small cell and non-small cell lung cancer.
- Have had another cancer within the last 5 years, unless it was treated and is no longer active.
- Have ongoing severe side effects from previous cancer treatments.
- Have active or past autoimmune or inflammatory disorders.
- Have received more than one line of prior anti-PD-(L)1 therapy.
- Have had severe side effects from previous anti-PD-(L)1 therapy that required stopping treatment.
- Have received more than one prior line of platinum-based chemotherapy for metastatic cancer.
- Have previously taken an ATR inhibitor.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 36607 | Mobile | Alabama |
| Research Site | 85224 | Chandler | Arizona |
| Research Site | 90720 | Los Alamitos | California |
| Research Site | 90017 | Los Angeles | California |
| Research Site | 90603 | Whittier | California |
| Research Site | 32256 | Jacksonville | Florida |
| Research Site | 32804 | Orlando | Florida |
| Research Site | 33612 | Tampa | Florida |
| Research Site | 30607 | Athens | Georgia |
| Research Site | 30318 | Atlanta | Georgia |
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