Efficacy and Safety of IBI308 and Paclitaxel/Albumin Paclitaxel for SCLC Patients Who Failed Etoposide Chemotherapy
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|ClinicalTrials.gov Identifier: NCT04056949|
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : August 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Extensive-Stage Small Cell Lung Cancer||Drug: Paclitaxel/Albumin-Bound Paclitaxel Drug: IBI308||Phase 2|
Primary objective :
To estimate progression free survival (PFS) probability of patient who recurrent SCLC treated with IBI308 combined with paclitaxel/abumin-bound paclitaxel following progression on platinum-etoposide chemotherapy.
I.To evaluate the objective remission rate (ORR), disease control rate. (DCR),durative time of remission ( DoR）and overall survival (OS) of IBI308 combined with paclitaxel/abumin-bound paclitaxel following progression on platinum-etoposide chemotherapy.
II.To evaluate the safety of IBI308 combined with paclitaxel/abumin-bound paclitaxel following progression on platinum-etoposide chemotherapy.
Exploratory Objectives To evaluate the correlation of biomarkers with efficacy and toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||SCLC patients who have failed platinum-etoposide chemotherapy|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy and Safety of IBI308 Combined With Paclitaxel/Albumin-Bound Paclitaxel as Second-Line Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer That Relapsed After Failing to Platinum-Etoposide Chemotherapy|
|Actual Study Start Date :||August 5, 2019|
|Estimated Primary Completion Date :||February 1, 2021|
|Estimated Study Completion Date :||December 31, 2021|
IBI308 + Paclitaxel/Albumin-Bound Paclitaxel
IBI308 Combined with Albumin-Bound Paclitaxe
Drug: Paclitaxel/Albumin-Bound Paclitaxel
Paclitaxel 175mg/m2 IV on day 1of 21 days cycle ;Number of Cycles: 4-6; or Albumin-bound paclitaxel 130mg/m2 IV on day 1 and 8 of 21 days cycle ;Number of Cycles: 4-6;
IBI308 200mg IV infusion, every 3 weeks,until disease progress or intolerable toxicity,used up to 1 year (or 16 cycles)
- progression-free survival (PFS) [ Time Frame: 12 months ]
- overall survival (OS) [ Time Frame: 12 months ]
- disease control rate (DCR) [ Time Frame: 12 months ]
- durative time of remission ( DoR） [ Time Frame: 12 months ]
- objective remission rate (ORR) [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056949
|Contact: Junling Li, doctor||+86 email@example.com|
|Beijing, Beijing, China, 100021|
|Contact: Junling Li, Doctor +86 13801178891 firstname.lastname@example.org|
|Principal Investigator:||Junling Li, doctor||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|