Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (SAPPHIRE)
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|ClinicalTrials.gov Identifier: NCT03906071|
Recruitment Status : Recruiting
First Posted : April 8, 2019
Last Update Posted : September 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Non-Squamous Non-Small Cell Lung Cancer||Biological: Nivolumab Drug: Sitravatinib Drug: Docetaxel||Phase 3|
|Study Type :||Interventional|
|Estimated Enrollment :||532 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase 3 Study of Sitravatinib in Combination With Nivolumab Versus Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer With Disease Progression On or After Platinum-Based Chemotherapy and Checkpoint Inhibitor Therapy SAPPHIRE|
|Actual Study Start Date :||July 15, 2019|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||December 2022|
Experimental: Nivolumab and Sitravatinib
Nivolumab will be administered by intravenous infusion over 30 minutes at 240 mg every 2 weeks or at 480 mg every 4 weeks. Sitravatinib capsules will be administered orally, once daily.
Nivolumab is an antibody directed at the programmed death receptor-1 (PD-1), blocking its interaction with PD-L1 and PD-L2.
Other Name: Opdivo
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
Other Name: MGCD516
Active Comparator: Docetaxel
Docetaxel will be administered by intravenous infusion at 75 mg/m2 over 1 hour every 3 weeks.
Docetaxel is an anti-neoplastic agent that acts by disrupting the microtubular network in cells.
Other Name: Taxotere
- Overall Survival (OS) [ Time Frame: 36 Months ]OS is defined as time from date of randomization to date of death due to any cause
- Adverse Events (AEs) [ Time Frame: 36 Months ]Frequency of patients experiencing treatment-emergent AEs
- Objective Response Rate (ORR) [ Time Frame: 36 Months ]ORR defined as complete response (CR) or partial response (PR) per RECIST version 1.1 recorded from randomization until disease progression or start of new anti-cancer therapy
- Progression-Free Survival (PFS) [ Time Frame: 36 months ]PFS is defined as the time from randomization to the date of the first documentation of objective disease progression or death due to any cause
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): NCT03906071
|Contact: Mirati Therapeutics Study Locator Services||1-844-893-5530 (toll free)||email@example.com|
|Study Director:||Ronald L. Shazer, MD, MBA||Mirati Therapeutics Inc.|