Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04878107
Status:
UNKNOWN
Last Update Posted:
2022-05-02
First Post:
2021-05-04
Brief Title:
SBRTLDRT in Combination With Camrelizumab and Apatinib in Metastatic Non-small Cell Lung Cancer Patient Previously Treated With PD-1L1 Inhibitor and Chemotherapy
Sponsor:
Wuhan University
Organization:
Wuhan University
Study Overview
Official Title:
SBRTLDRT in Combination With Camrelizumab and Apatinib in Metastatic Non-small Cell Lung Cancer Patient Previously Treated With PD-1L1 Inhibitor and Chemotherapya Prospective Exploratory Study
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
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:
SABRE
Brief Summary:
SABRE STUDY will explore effectiveness and safety of the combination therapy of camrelizumabapatinib and SBRTLDRT in patients with metastatic non-small Cell Lung Cancer NSCLC patient previously treated With PD-1L1 Inhibitor and Chemotherapy
Detailed Description:
SABRE STUDY consists of two stages
first stage of this trial is a single-arm study that requires enrolling at least 18 patients all of whom would receive the treatment of SBRTLDRT in combination with apatinib plus camrelizumabThe trial would proceed into the second stage if 4 or more patients achieve CRPR Otherwise the trial is stopped early due to futility as we fail to reject the null
In the second stage at least 70 patients are equally randomized into two arms to receive SBRTLDRT in combination with apatinib plus camrelizumab or SBRT docetaxel Stratified-area group randomization would be used
first stage of this trial is a single-arm study that requires enrolling at least 18 patients all of whom would receive the treatment of SBRTLDRT in combination with apatinib plus camrelizumabThe trial would proceed into the second stage if 4 or more patients achieve CRPR Otherwise the trial is stopped early due to futility as we fail to reject the null
In the second stage at least 70 patients are equally randomized into two arms to receive SBRTLDRT in combination with apatinib plus camrelizumab or SBRT docetaxel Stratified-area group randomization would be used
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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