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 : March 12, 2021
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Non-Squamous Non-Small Cell Lung Cancer | Biological: Nivolumab Drug: Sitravatinib Drug: Docetaxel | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 532 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 : | September 2022 |
Estimated Study Completion Date : | July 2023 |

Arm | Intervention/treatment |
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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.
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Biological: Nivolumab
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 Drug: Sitravatinib 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.
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Drug: Docetaxel
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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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) | miratistudylocator@emergingmed.com |

Study Director: | Ronald L. Shazer, MD, MBA | Mirati Therapeutics Inc. |
Responsible Party: | Mirati Therapeutics Inc. |
ClinicalTrials.gov Identifier: | NCT03906071 |
Other Study ID Numbers: |
516-005 |
First Posted: | April 8, 2019 Key Record Dates |
Last Update Posted: | March 12, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Sitravatinib Nivolumab Docetaxel Checkpoint inhibitor |
MGCD516 NSCLC SAPPHIRE |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic |
Bronchial Neoplasms Docetaxel Nivolumab Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Immunological |