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

Prior treatment

• 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.

Other

• Participant with mixed SCLC and NSCLC histology

• 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.