Study of ceralasertib plus durvalumab versus docetaxel for patients with advanced or metastatic non-small cell lung cancer

Phase 1

• Conditions: Advanced or Metastatic Non-Small Cell Lung Cancer; MedDRA version: 21.1Level: PTClassification code: 10059515Term: Non-small cell lung cancer metastatic Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-509429-37-00
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-14
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 892

Inclusion Criteria

Participant must be = 18 years at the time of screening., Negative pregnancy test (serum test) for WOCBP., Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology., Documented EGFR and 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., ECOG/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.

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 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 ATR inhibitor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified