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NCT05941897Active, 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

A Phase II, Open-label, Multicentre, Non-comparative, Single-arm Local Study of Ceralasertib Plus Durvalumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy

Source: ClinicalTrials.gov · Last updated 9 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
39 (actual)
First submitted
12 Jun 2023
Start date
21 Jun 2023
Primary completion date
29 Jul 2024
Lead sponsor
AstraZeneca
Diseases
Lung cancer
NCT number
NCT05941897

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 39
  • From 21 Jun 2023 to the primary completion date, 29 Jul 2024
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.
  • Participants who have received a prior ATR inhibitor.

Other illness

  • History of leptomeningeal carcinomatosis.
  • 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.

Other

  • Participant with mixed SCLC and NSCLC histology.
  • Diagnosis of ataxia telangiectasia.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status
-
Coordinator of this site? Confirm its status
Nizhny NovgorodRussiaUnknown status
-
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.