Ignite Creation Date:
2024-05-06 @ 9:40 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03043872
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2017-01-18
Brief Title:
Durvalumab Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer CASPIAN
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase III Randomized MulticenterOpen-Label Comparative Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for the First-Line Treatment in Patients With Extensive Disease Small-Cell Lung Cancer SCLC CASPIAN
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
CASPIAN
Brief Summary:
This is a phase III randomized open-label multicenter global study to determine the efficacy and safety of combining durvalumab tremelimumab with platinum based chemotherapy EP followed by durvalumab tremelimumab maintenance therapy versus EP alone as first-line treatment in patients with extensive-stage small-cell lung cancer
Detailed Description:
Primary objective of this study is to assess the efficacy of durvalumab tremelimumab EP treatment compared with EP and the efficacy of durvalumab EP treatment compared with EP in terms of OS
All patients will be randomized in a 111 ratio in a stratified manner according to the planned platinum-based therapy for Cycle 1 cisplatin or carboplatin to receive treatment with durvalumab tremelimumab EP Arm 1 durvalumab EP Arm 2 or standard of care- EP Arm 3 Arm 1 and Arm 2 patients receive the treatment until confirmed disease progression while Arm 3 patients receive up to 6 cycles of EP and prophylactic cranial irradiation if clinically indicated at the Investigators discretionPatients who have discontinued treatment due to toxicity or symptomatic deterioration clinical progression or who have commenced subsequent anticancer therapy will be followed up until 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 at Week 6 1 week from the date of randomization at Week 12 1 week from the date of randomization and then every 8 weeks 1 week until confirmed objective disease progression
An independent data monitoring committee IDMC comprised of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule of durvalumab tremelimumab in combination with platinum based chemotherapy at two early stages of enrolment
All patients will be randomized in a 111 ratio in a stratified manner according to the planned platinum-based therapy for Cycle 1 cisplatin or carboplatin to receive treatment with durvalumab tremelimumab EP Arm 1 durvalumab EP Arm 2 or standard of care- EP Arm 3 Arm 1 and Arm 2 patients receive the treatment until confirmed disease progression while Arm 3 patients receive up to 6 cycles of EP and prophylactic cranial irradiation if clinically indicated at the Investigators discretionPatients who have discontinued treatment due to toxicity or symptomatic deterioration clinical progression or who have commenced subsequent anticancer therapy will be followed up until 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 at Week 6 1 week from the date of randomization at Week 12 1 week from the date of randomization and then every 8 weeks 1 week until confirmed objective disease progression
An independent data monitoring committee IDMC comprised of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule of durvalumab tremelimumab in combination with platinum based chemotherapy at two early stages of enrolment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-001203-23 | EUDRACT_NUMBER | None | None |