Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05450692 | 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 | PHASE3 | ACTIVE NOT_RECRUITING | 594 | — | — | Sep 15, 2022 | Dec 31, 2027 | Apr 16, 2026 | 191 | United States, Argentina +21 |
The superiority of ceralasertib plus durvalumab combination therapy relative to docetaxel will be demonstrated by assessment of OS (HR with 95% CI and p-value) 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 cause.
| Arm | Type | Description |
|---|---|---|
| Group A: Ceralasertib plus durvalumab combination therapy | EXPERIMENTAL | Participants will be administered ceralasertib orally followed by durvalumab administered intravenously. |
| Group B: Docetaxel monotherapy | ACTIVE_COMPARATOR | Participants will be administered docetaxel (standard of care) administered intravenously. |
| Name | Type | Description |
|---|---|---|
| Ceralasertib | DRUG | Participants will receive ceralasertib oral tablets. |
| Durvalumab | DRUG | Participants will receive durvalumab as an intravenous infusion. |
| Docetaxel | DRUG | Participants will received docetaxel as an intravenous infusion. |
Inclusion Criteria: * Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology. * Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status as determ...