NCT05941897

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
8mo left

Started Jun 2023

Typical duration for phase_2

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jun 2023Jan 2027

First Submitted

Initial submission to the registry

June 12, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

June 21, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2024

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

June 12, 2023

Last Update Submit

March 4, 2026

Conditions

Advanced or Metastatic NSCLC

Keywords

Lung NeoplasmsLung DiseasesCarcinoma, Non-Small-Cell LungCarcinoma, BronchogenicRespiratory Tract DiseasesBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsDurvalumabCeralasertibATR inhibitorImmunotherapy

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR)

    Objective response rate (ORR) is defined as the proportion of participants who have a complete response (CR) or partial response (PR) per RECIST 1.1.

    At month 6 after the last patient's first dose (approximately 18 months).

Secondary Outcomes (6)

  • Duration of Response (DoR)

    Up to 30 months

  • Time to response (TTR)

    Up to 30 months

  • Disease control rate (DCR)

    At month 6 after the last patient's first dose (approximately 18 months).

  • Progression free survival (PFS)

    Up to 30 months

  • Overall survival (OS)

    Up to 30 months

  • +1 more secondary outcomes

Study Arms (1)

Group A

EXPERIMENTAL

Ceralasertib plus durvalumab combination therapy Participants will be administered orally ceralasertib followed by IV durvalumab each 28 days cycle.

Drug: CeralasertibDrug: Durvalumab

Interventions

CeralasertibDRUG

Participants will receive ceralasertib oral tablets.

Group A
DurvalumabDRUG

Participants will receive durvalumab as an intravenous infusion

Group A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Research Site

Moscow, 111123, Russia

Location

Research Site

Moscow, 115478, Russia

Location

Research Site

Moscow, 115533, Russia

Location

Research Site

Moscow, 125284, Russia

Location

Research Site

Moscow, 143423, Russia

Location

Research Site

Nizhny Novgorod, 603126, Russia

Location

Research Site

Saint Petersburg, 197758, Russia

Location

Research Site

Saint Petersburg, 198255, Russia

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung NeoplasmsLung DiseasesCarcinoma, BronchogenicRespiratory Tract DiseasesBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasms

Interventions

ceralasertibdurvalumab

Condition Hierarchy (Ancestors)

Bronchial Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2023

First Posted

July 12, 2023

Study Start

June 21, 2023

Primary Completion

July 29, 2024

Study Completion (Estimated)

January 1, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.Yes,indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
More information

Locations

RU(8)