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 metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-000493-26-IT
• Lead Sponsor: ASTRAZENECA AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-28
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

1. Participant must be >= 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 EGFR and 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. ECOG/WHO performance status of 0 or 1.
7. Adequate organ function and marrow reserve
8. Minimum life expectancy of 12 weeks.
9. Body weight > 30 kg and no cancer-associated cachexia.
10. Negative pregnancy test (serum test) for WOCBP.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 260

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 >= 5 years before the first dose of study intervention.
3. Persistent toxicities (CTCAE Grade > 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 >= 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.
7. Participants who have received more than one prior line of platinum- based chemotherapy in metastatic setting.
8. Participants who have received a prior ATR inhibitor.

Study & Design

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