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Active Not Recruiting
NCT05941897
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
Conditions: Advanced or Metastatic NSCLC
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 39
Sponsor: AstraZeneca
Location: Research Site Moscow
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.
Eligibility Criteria
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(L)1 therapy.
* Participants must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged.
* Participants who have received more than one prior line of platinum-based chemotherapy in metastatic setting.
* As judged by the investigator, any evidence of medical condition, which, in the investigator's opinion, makes it undesirable for the participant to participate in the study.
* Participants who have received a prior ATR inhibitor.
* Diagnosis of ataxia telangiectasia.
Source: ClinicalTrials.gov (NCT05941897). StuddyBuddy aggregates publicly available trial information.