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

Phase 3

• Conditions: Health Condition 1: C349- Malignant neoplasm of unspecifiedpart of bronchus or lung

• Registration Number: CTRI/2023/01/048703
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Participant must be greater than or equal to 18 years at the time of screening

2.Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.

3.Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status as determined at a local laboratory.

4.Documented radiological PD whilst on or after receiving the most recent treatment regimen.

5.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.

6.Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0 or 1.

7.Adequate organ function and marrow reserve Minimum life expectancy of 12 weeks.

8.Body weight greater than 30 kg and no cancer-associated cachexia.

9.Negative pregnancy test (serum test) for women of childbearing potential (WOCBP).

Exclusion Criteria

1.Participant with mixed SCLC and NSCLC histology.

2.History of another primary malignancy except for malignancy treated with curative intent with no known active disease greater than or equal to 5 years before the first dose of study intervention.

3.Persistent toxicities (CTCAE Grade greater than 2) caused by previous anticancer therapy.

4.Active or prior documented autoimmune or inflammatory disorders.

5.Participants who have received more than one line of prior anti-PD-(L)1, either alone or in any combination.

6.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 greater than or equal to 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 greater than 10 mg prednisone or equivalent per day.

7.Participants who have received more than one prior line of platinum-based chemotherapy in metastatic setting.

8.Participants who have received a prior ataxia telangiectasia and Rad3-related protein (ATR) inhibitor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate superiority of ceralasertib plus durvalumab combination therapy relative to docetaxel by assessment of OS in participants with advanced NSCLC after second- or third-line therapy and without actionable genomic alterations. OS is defined as time from randomisation until the date of death due to any causeTimepoint: Overall Survival (OS) Time Frame: every 3 months (± 1 week) following objective progression of disease (PD) or treatment discontinuation (up to three years)