First-line patients with extensive disease small-cell lung cancer (SCLC) MedDRA version: 21.1 Level: PT Classification code 10041068 Term: Small cell lung cancer extensive stage System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Documented evidence of extensive stage SCLC (ES-SCLC) • Participants must be considered suitable to receive a platinum-based chemotherapy regimen, combined with durvalumab, as first-line treatment for ES-SCLC • No prior exposure to immune-mediated therapy • Life expectancy =12 weeks at Day 1. • ECOG 0 or 1 at enrolment. 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 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: • Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy • Has a paraneoplastic syndrome (PNS) of autoimmune systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS • Active infection including tuberculosis, HIV, hepatitis B and C • Active or prior documented autoimmune or inflammatory disorders • Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of AZD2811 + durvalumab by 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 Objective: - To evaluate efficacy of AZD2811 + durvalumab: - proportion of participants alive at 12 months OS12, 15 months OS15, and 18 months OS18 who have not progressed during induction. - proportion of participants alive and progression free at 6 months APF6 and 9 months APF9 who have not progressed during induction. - assessment of Objective response rate (ORR): - in all participants in induction. - in participants who had not progressed during induction. - assessment of PFS in participants who had not progressed during induction. - assessment of OS in participants who had not progressed during induction. - To assess the safety and tolerability profile of study intervention in SCLC. - To evaluate the PK of durvalumab and AZD2811. - To evaluate the effect of AZD2811 + durvalumab on SCLC symptoms and health-related QoL using EORTC QLQ-C30 and QLQ-LC13.;Primary end point(s): Maintenance participants alive and progression free (APF12);Timepoint(s) of evaluation of this end point: Up to 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Maintenance participants alive at 12 months (OS12), 15 months (OS15), and 18 months (OS18) 2. Maintenance participants alive and progression free at 6 months (APF6) and 9 months (APF9) using investigator assessments according to RECIST 1.1 3. Objective response rate (ORR) for all participants using investigator assessments according to RECIST 1.1. 4. Maintenance participants Progression-free survival (PFS) using investigator assessments according to RECIST 1.1 5. Overall survival (OS) in maintenance participants 6. The safety and tolerability profile of study intervention in SCLC. 7. The pharmacokinetics of durvalumab and AZD2811. 8. Disease-related symptoms & Health-related QoL measured by EORTC QLQ-LC30 & EORTC QLQ-LC13;Timepoint(s) of evaluation of this end point: 1. Up to 18 months 2. Up to 9 months 3. to 8. Up to approximately 3 years | — |
Countries
Korea, Republic of, Poland, Spain, United States
Contacts
Public ContactInformation Center
AstraZeneca AB
Outcome results
None listed