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PARP Inhibitor

Ceralasertib + Durvalumab for Lung Cancer (LATIFY Trial)

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
Pivotal Trial

LATIFY Trial Summary

This trialwill test a new drug combo to treat advanced lung cancer after other treatments have failed.

Who is the study for?
This trial is for adults with advanced NSCLC who have already tried anti-PD-(L)1 and platinum-based chemotherapy without success. They should not be pregnant, must have a good performance status (able to carry out daily activities), adequate organ function, and no severe weight loss due to cancer. People with certain other cancers or those who've had serious side effects from previous immunotherapies can't join.Check my eligibility
What is being tested?
The study compares the effectiveness of Ceralasertib combined with Durvalumab against the standard treatment Docetaxel in patients whose NSCLC has worsened despite prior therapies. It aims to see if this new combination can improve outcomes for these patients.See study design
What are the potential side effects?
Possible side effects include immune system reactions that could affect organs, infusion-related responses, fatigue, digestive issues like nausea or diarrhea, blood cell count changes increasing infection risk, and potential allergic reactions.

LATIFY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is advanced or has spread, as confirmed by tests.
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My cancer is not caused by changes in the EGFR or ALK genes.
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My cancer has worsened despite my most recent treatment.
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I've had treatments for advanced lung cancer including anti-PD-(L)1 and platinum-based therapy.
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I am fully active or can carry out light work.
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My organs and bone marrow are working well.
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I weigh more than 30 kg and do not have severe weight loss due to cancer.

LATIFY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response (DoR)
Number of participants with Adverse Evens (AEs)
+8 more

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

LATIFY Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group A: Ceralasertib plus durvalumab combination therapyExperimental Treatment2 Interventions
Participants will be administered ceralasertib orally followed by durvalumab administered intravenously.
Group II: Group B: Docetaxel monotherapyActive Control1 Intervention
Participants will be administered docetaxel (standard of care) administered intravenously.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceralasertib
Not yet FDA approved
Durvalumab
FDA approved

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,224 Previous Clinical Trials
288,417,685 Total Patients Enrolled
ParexelIndustry Sponsor
300 Previous Clinical Trials
99,620 Total Patients Enrolled

Media Library

Ceralasertib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05450692 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Group A: Ceralasertib plus durvalumab combination therapy, Group B: Docetaxel monotherapy
Non-Small Cell Lung Cancer Clinical Trial 2023: Ceralasertib Highlights & Side Effects. Trial Name: NCT05450692 — Phase 3
Ceralasertib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05450692 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How can people with this condition sign up for the trial?

"The study, which was first shared on September 15th, is looking for volunteers. The information available on clinicaltrials.gov was last updated on October 7th, 20202."

Answered by AI

How many people can volunteer for this clinical trial at most?

"Accessing the information available on clinicaltrials.gov, it appears as though this study is still recruiting patients. This trial was first made public on September 15th, 2020 and the most recent update was October 7th, 2020. The aim is to enroll 580 individuals across 11 different research sites."

Answered by AI

Could you tell me how many research centers are participating in this project?

"To limit travel-related complications, it is best to select a trial site near you from the 11 available locations. These include clinics in Atlanta, Allentown and Los Angeles among other cities."

Answered by AI

What are ceralasertib and durvalumab's side effects?

"Group A: Ceralasertib plus durvalumab combination therapy is considered safe, with a score of 3. This is due to the fact that it is a Phase 3 trial, which implies that in addition to some efficacy data, there are also multiple rounds of safety data supporting this conclusion."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
~254 spots leftby May 2025