Clinical trial · Interventional
Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Non-Squamous Non-Small Cell Lung Cancer | Lung Non-Squamous Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nivolumab and Sitravatinib
- description
- 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.
- interventionNames
- Biological: Nivolumab
- Drug: Sitravatinib
- type
- ACTIVE_COMPARATOR
- label
- Docetaxel
- description
- Docetaxel will be administered by intravenous infusion at 75 mg/m2 over 1 hour every 3 weeks.
- interventionNames
- Drug: Docetaxel
Primary outcomes (1)
- measure
- Overall Survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available