Group A: Ceralasertib plus durvalumab combination therapy for Malignant Neoplasms

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Malignant Neoplasms+2 More
Ceralasertib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Malignant Neoplasms

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Up to 3 years

At 12 months
Overall Survival (OS) at 12 months
At Week 18
Disease Control Rate (DCR)
Month 3
Overall Survival (OS)
Up to 3 years
Duration of Response (DoR)
Number of participants with Adverse Evens (AEs)
Objective Response Rate (ORR)
Plasma concentrations for ceralasertib plus durvalumab combination therapy
Progression-Free Survival (PFS)
TTD of physical function
Time To Deterioration (TTD) of health-related quality of life (QoL)
Time To Response (TTR)
Time to second progression or death (PFS2)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Group B: Docetaxel monotherapy
1 of 2
Group A: Ceralasertib plus durvalumab combination therapy
1 of 2
Active Control
Experimental Treatment

580 Total Participants · 2 Treatment Groups

Primary Treatment: Group A: Ceralasertib plus durvalumab combination therapy · No Placebo Group · Phase 3

Group A: Ceralasertib plus durvalumab combination therapyExperimental Group · 2 Interventions: Ceralasertib, Durvalumab · Intervention Types: Drug, Drug
Group B: Docetaxel monotherapy
Drug
ActiveComparator Group · 1 Intervention: Docetaxel · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceralasertib
2017
Completed Phase 1
~30
Durvalumab
2017
Completed Phase 2
~3200

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

AstraZenecaLead Sponsor
3,956 Previous Clinical Trials
91,808,289 Total Patients Enrolled
ParexelIndustry Sponsor
268 Previous Clinical Trials
94,666 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Documented radiological PD whilst on or after receiving the most recent treatment regimen.
You are 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.
You have a performance status of 0 or 1.
You have a minimum life expectancy of 12 weeks.
You are 30 kilograms or more, and no cancer-associated cachexia.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: October 15th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.