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 Ch

• Status: Active, not recruiting
• Trial end date: 2025-07-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Durvalumab

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.