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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
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

NCT05941897

Active Not RecruitingPhase 2

Sponsor: AstraZeneca

Conditions: Advanced or Metastatic NSCLC

Interventions: Ceralasertib, Durvalumab

Countries: Russia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (8)
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Nizhny Novgorod, Russia
  • Saint Petersburg, Russia
  • Saint Petersburg, Russia