DEFOSBARASERTIB for Extensive-stage small cell lung cancer

Inclusion criteria

• {"criterion_text":"- Documented evidence of extensive stage SCLC (ES-SCLC)\n- Participants must be considered suitable to receive a platinum-based chemotherapy regimen, combined with durvalumab, as first-line treatment for ES-SCLC\n- No prior exposure to immune-mediated therapy\n- Life expectancy ≥12 weeks\n- ECOG 0 or 1 at enrolment"}

Exclusion criteria

• {"criterion_text":"- Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy\n- Has a paraneoplastic syndrome (PNS) of autoimmune systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS\n- Active infection including tuberculosis, HIV, hepatitis B and C\n- Active or prior documented autoimmune or inflammatory disorders\n- Uncontrolled intercurrent illness, including but not limited to interstitial lung disease"}

Primary endpoints

• {"endpoint_text":"- Maintenance participants alive and progression free (APF12)","definition_or_measurement_approach":"Assessment of the proportion of participants alive and progression free at 12 months (APF12) who have not progressed during EP-durvalumab based induction therapy"}

Secondary endpoints

• {"endpoint_text":"- Maintenance participants alive at 12 months (OS12), 15 months (OS15), and 18 months (OS18)\n- Maintenance participants alive and progression free at 6 months (APF6) and 9 months (APF9) using investigator assessments according to RECIST 1.1\n- Objective response rate (ORR) for all participants using investigator assessments according to RECIST 1.1\n- Maintenance participants Progression-free survival (PFS) using investigator assessments according to RECIST 1.1\n- Overall survival (OS) in maintenance participants\n- The safety and tolerability profile of study intervention in SCLC\n- The pharmacokinetics of durvalumab and AZD2811\n- Disease-related symptoms & Health-related QoL measured by EORTC QLQ-LC30 & EORTC QLQ-LC13","definition_or_measurement_approach":"OS endpoints measured as proportion alive at specified timepoints; APF6/APF9 and PFS/ORR assessed using investigator assessments according to RECIST 1.1; PK assessed for durvalumab and AZD2811; QoL measured by EORTC QLQ-C30 and QLQ-LC13; safety/tolerability assessed by standard safety reporting"}

Spain

Earliest CTIS Part Ii Submission Date

19-06-2024

Latest Decision Or Authorization Date

09-02-2026

Processing Time Days

600

Number Of Sites

1

Number Of Participants

3

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Fortrea Inc.

Responsibilities

sponsorDuties codes: [1,11,12,8,9]; submissions contact: submissions@fortrea.com

Third parties

• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties codes: [1,11,12,8,9]; contact email submissions@fortrea.com; address: 8 Moore Drive, Durham, 27709-0009, United States","organisation_type":"Pharmaceutical company"}