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 (LOTOS)

AstraZeneca

Status and phase

Active, not recruiting

Phase 2

Conditions

Advanced or Metastatic NSCLC

Treatments

Drug: Ceralasertib

Drug: Durvalumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05941897

AZ-RU-00001

Details and patient eligibility

About

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.

Full description

This is a single-arm study, all participants will be assigned to one treatment group - ceralasertib plus durvalumab combination therapy. Each 28-day cycle will begin with ceralasertib administered orally followed by durvalumab administered intravenously.

The objectives of the current single-arm local study are to estimate the efficacy and safety of ceralasertib and durvalumab combination in local population to obtain relevant information for routine clinical practice. The results of this additional study will provide clinical data on efficacy and safety of an innovation drug in the new region - Russian Federation.

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.