Health conditions
(Data source: WHO)
Metastatic Non-Squamous Non-Small Cell Lung Cancer
Interventions (Data source: WHO)
Biological: Nivolumab;Drug: Sitravatinib;Drug: Docetaxel
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Diagnosis of Non-Squamous Non-Small Cell Lung Cancer
- Receipt of at least one but not more than two prior treatment regimens in the advanced
setting
- Prior treatment with PD-1/PD-L1 checkpoint inhibitor therapy and platinum-based
chemotherapy in combination or in sequence (i.e., platinum-based chemotheraphy
followed by checkpoint inhibitor therapy)
- Most recent treatment regimen must have included a checkpoint inhibitor therapy with
radiographic disease progression on or after treatment
- Candidate to receive docetaxel as second or third line therapy
Exclusion Criteria:
- Uncontrolled brain metastases
- Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions
- Unacceptable toxicity with prior checkpoint inhibitor therapy
- Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than
maintenance chemotherapy
- Impaired heart function
-
Further information on trial
Recruitment status
Active, not recruiting
Academic title
(Data source: WHO)
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
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
Overall Survival (OS)
Secundary end point
(Data source: WHO)
Adverse Events (AEs);Objective Response Rate (ORR);Progression-Free Survival (PFS)
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Countries
(Data source: WHO)
Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
Contact for further information on the trial
Contact for general information
(Data source: WHO)
Ronald L. Shazer, MD, MBA
Mirati Therapeutics Inc.
Contact for scientific information
(Data source: WHO)
Ronald L. Shazer, MD, MBA
Mirati Therapeutics Inc.
Further trial identification numbers
Secondary ID (Data source: WHO)
516-005
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