A Phase III Study of Ceralasertib plus Durvalumab versus Docetaxel in Patients with Non Small Cell Lung Cancer (NSCLC) Whose Disease Progressed On or After Prior Anti PD (L)1 Therapy And Platinum Based Chemotherapy - LATIFY

Study identifier:D533BC00001

ClinicalTrials.gov identifier:NCT05450692

EudraCT identifier:2022-000493-26

CTIS identifier:N/A

Recruiting

Official Title

A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel 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: LATIFY

Medical condition

Advanced or Metastatic Non-Small Cell Lung Cancer

Phase

Phase 3

Healthy volunteers

Study drug

Ceralasertib, Durvalumab, Docetaxel

Sex

All

Estimated Enrollment

580

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 15 Sept 2022

Estimated Primary Completion Date: 22 May 2025

Estimated Study Completion Date: 22 May 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Mar 2024 by AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion 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 as determined at a local laboratory.
- 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 either separately or in combination.
- Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0 or 1.
- Adequate organ function and marrow reserve
- Minimum life expectancy of 12 weeks.
- Body weight > 30 kg and no cancer-associated cachexia.
- Negative pregnancy test (serum test) for women of childbearing potential (WOCBP).

Exclusion Criteria

- Participant with mixed SCLC and NSCLC histology.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention.
- 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, either alone or in any combination.
- Participants:
(a) Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy.
(b) All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved.
(c) 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.
(d) 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, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day.
- Participants who have received more than one prior line of platinum-based chemotherapy in metastatic setting.
- Participants who have received a prior ataxia telangiectasia and Rad3-related protein (ATR) inhibitor.

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Arms	Assigned Interventions
Experimental: Group A: Ceralasertib plus durvalumab combination therapy Participants will be administered ceralasertib orally followed by durvalumab administered intravenously.	Drug: Ceralasertib Participants will receive ceralasertib oral tablets. Drug: Durvalumab Participants will receive durvalumab as an intravenous infusion.
Active Comparator: Group B: Docetaxel monotherapy Participants will be administered docetaxel (standard of care) administered intravenously.	Drug: Docetaxel Participants will received docetaxel as an intravenous infusion.

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]