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Advanced or Metastatic NSCLCPhase 2LOTOSNCT05941897

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 2 study testing Ceralasertib and Durvalumab in people with Advanced or Metastatic NSCLC, run by AstraZeneca at 8 sites in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced or Metastatic NSCLC
What is being tested?
Ceralasertib and Durvalumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
8 sitesRussia
Study dates
21 Jun 2023to 1 Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Russia8 sites

  • Research Site

    Moscow, 111123

  • Research Site

    Moscow, 115478

  • Research Site

    Moscow, 115533

  • Research Site

    Moscow, 125284

  • Research Site

    Moscow, 143423

  • Research Site

    Nizhny Novgorod, 603126

  • Research Site

    Saint Petersburg, 197758

  • Research Site

    Saint Petersburg, 198255

Other trials in Russia

About this study

Official title: 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

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.

Read the detailed 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.

Being tested
Ceralasertib, Durvalumab
Keywords
Lung Neoplasms, Lung Diseases, Carcinoma, Non-Small-Cell Lung, Carcinoma, Bronchogenic, Respiratory Tract Diseases, Bronchial Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Durvalumab, Ceralasertib, ATR inhibitor, Immunotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Lung Diseases, Carcinoma, Bronchogenic, Respiratory Tract Diseases, Bronchial Neoplasms, Respiratory Tract Neoplasms, Thoracic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CeralasertibDrug

    Participants will receive ceralasertib oral tablets.

  • DurvalumabDrug

    Participants will receive durvalumab as an intravenous infusion

Study groups in NCT05941897
Study groupRoleWhat they receive
Group AExperimentalCeralasertib plus durvalumab combination therapy Participants will be administered orally ceralasertib followed by IV durvalumab each 28 days cycle.
Receives: Drug: Ceralasertib; Drug: Durvalumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  1. Duration of Response (DoR)

    DoR is defined as the time from the date of first documented response until date of documented progression per RECIST 1.1.

    Measured: Up to 30 months

  2. Time to response (TTR)

    Time to response (TTR) is defined as the time from the start of treatment until the date of first documented objective response per RECIST 1.1.

    Measured: Up to 30 months

  3. Disease control rate (DCR)

    DCR at 18 weeks is defined as the percentage of participants who have a CR or PR or who have stable disease (SD) for at least 17 weeks per RECIST 1.1.

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

  4. Progression free survival (PFS)

    PFS is defined as time from the start of treatment until progression per Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1).

    Measured: Up to 30 months

  5. Overall survival (OS)

    OS is defined as time from the start of treatment until the date of death due to any cause.

    Measured: Up to 30 months

  6. Number and percentage of AEs in patients receiving Ceralasertib and Durvalumab combination

    The safety and tolerability profile of Ceralasertib and Durvalumab combination will be evaluated using vital signs, laboratory data, electrocardiograms (ECGs), and adverse event data

    Measured: Up to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2023
  2. Study start21 Jun 2023
  3. Primary completion29 Jul 2024
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05941897
Sponsor's protocol ID
AZ-RU-00001
Acronym
LOTOS
Status last verified
Sep 2026
First submitted
12 Jun 2023
Last updated
9 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ceralasertib and Durvalumab in people with Advanced or Metastatic NSCLC, run by AstraZeneca at 8 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: At month 6 after the last patient's first dose (approximately 18 months).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05941897.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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