Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04745689
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-12-15
First Post:
2020-12-16
Brief Title:
Study of AZD2811 Durvalumab in ES-SCLC
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase II Multicenter Open-Label Single Arm Study to Determine the Efficacy Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction With Platinum-Based Chemotherapy Combined With Durvalumab for the First-Line Treatment of Patients With Extensive Stage Small-Cell Lung Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TAZMAN
Brief Summary:
A Phase II Multicenter Open-Label Single Arm Study to Determine the Efficacy Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction with Platinum-Based Chemotherapy Combined with Durvalumab for the First-Line Treatment of Patients with Extensive Stage Small-Cell Lung Cancer
Detailed Description:
Primary objective of this study is to evaluate the efficacy of AZD2811 and durvalumab in patients who have not progressed following induction therapy with platinum-based chemotherapy combined with durvalumab
This is an open-label single arm study Patients will be treated in an induction phase with platinum-based induction therapy and durvalumab At the end of this induction period participants will be assessed for disease progression per RECIST v11
Participants who have not progressed per RECIST v11 at the end of the induction phase will roll over into the maintenance phase of the trial where patients will commence AZD2811 and durvalumab combination
Participants will be treated with AZD2811 and durvalumab as maintenance therapy until confirmed progressive disease start of non-protocol defined anticancer therapy unacceptable toxicity or withdrawal of consent
If study intervention is permanently discontinued the participant will remain in the study to be evaluated for safety assessment as well as for confirmed disease progression and for survival
Targeted population are adult patients aged 18 years with histologically or cytologically documented extensive disease American Joint Committee on Cancer Stage 7th edition IV SCLC T any N anyM1 ab or T3-4 due to multiple lung nodules that are too extensive or have tumornodal volume that is too large to be encompassed in a tolerable radiation plan Patients must have WHOECOG performance status of 0 or 1
Tumor assessments will be performed at Screening as baseline with follow-up every 6 weeks 1 week for the first 36 weeks and then every 8 weeks 1 week until confirmed objective disease progression
This is an open-label single arm study Patients will be treated in an induction phase with platinum-based induction therapy and durvalumab At the end of this induction period participants will be assessed for disease progression per RECIST v11
Participants who have not progressed per RECIST v11 at the end of the induction phase will roll over into the maintenance phase of the trial where patients will commence AZD2811 and durvalumab combination
Participants will be treated with AZD2811 and durvalumab as maintenance therapy until confirmed progressive disease start of non-protocol defined anticancer therapy unacceptable toxicity or withdrawal of consent
If study intervention is permanently discontinued the participant will remain in the study to be evaluated for safety assessment as well as for confirmed disease progression and for survival
Targeted population are adult patients aged 18 years with histologically or cytologically documented extensive disease American Joint Committee on Cancer Stage 7th edition IV SCLC T any N anyM1 ab or T3-4 due to multiple lung nodules that are too extensive or have tumornodal volume that is too large to be encompassed in a tolerable radiation plan Patients must have WHOECOG performance status of 0 or 1
Tumor assessments will be performed at Screening as baseline with follow-up every 6 weeks 1 week for the first 36 weeks and then every 8 weeks 1 week until confirmed objective disease progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None