Loading clinical trials...

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 | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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

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

NCT05450692•AstraZeneca

View on ClinicalTrials.gov

Summary

This study will assess the efficacy and safety of the combination of ceralasertib and durvalumab versus standard of care docetaxel in patients with locally advanced and metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based chemotherapy.

Detailed Description

This study will consist of two treatment arms (Groups A and B). Participants will be randomised in a 1:1 ratio to one of the two treatment groups: * Group A: Ceralasertib plus durvalumab combination therapy Each 28-day cycle will begin with ceralasertib administered orally followed by durvalumab administered intravenously. * Group B: Docetaxel monotherapy Each 21-day cycle will begin with the administration of docetaxel.

Eligibility

Age

18 - 130 years

Sex

ALL

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 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:
•1. Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy.
•2. All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved.
•3. 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.
•4. 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.
+2 more criteria

Locations (193)

Research Site

Mobile, Alabama, United States

Research Site

Chandler, Arizona, United States

Research Site

Los Alamitos, California, United States

Research Site

Los Angeles, California, United States

Research Site

Whittier, California, United States

Research Site

Jacksonville, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Tampa, Florida, United States

Research Site

Athens, Georgia, United States

Research Site

Atlanta, Georgia, United States

Key Dates

Start Date

September 15, 2022

Primary Completion Date

October 6, 2025

Completion Date

October 30, 2026

Last Updated

November 19, 2025

Enrollment

594

ACTUAL participants

Conditions

Advanced or Metastatic Non-Small Cell Lung Cancer

Interventions

Ceralasertib

DRUG

Durvalumab

DRUG

Docetaxel

DRUG

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AST2303 Tablets (ABK3376 Tablets) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

NCT06955988

Locally Advanced or Metastatic Non-small Cell Lung Cancer

View study

RECRUITINGPHASE1/PHASE2

A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors

NCT06581419

Advanced Malignant NeoplasmAdvanced or Metastatic Non-small Cell Lung Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AST2303 Tablets (ABK3376 Tablets) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer

A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors

A Randomized Phase 2 Trial of TAS-114 in Combination With S-1 Versus S-1

Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Non-Small Cell Lung Cancer

Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer