NCT03906071CompletedPhase 3
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: EU CTIS (euclinicaltrials.eu) · Last updated 24 Sept 2025
Brief summary (registry, in English)
To compare Overall Survival (OS) in patients with non-squamous NSCLC who have experienced disease progression on or after platinum-based chemotherapy and CIT, treated with sitravatinib and nivolumab versus docetaxel.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 196 (actual)
- First submitted
- 6 Aug 2024
- Start date
- 18 Dec 2020
- Lead sponsor
- Mirati Therapeutics Inc.
- Diseases
- Lung cancer
- NCT number
- NCT03906071
- EU CT number
- 2024-516598-60-00
- EudraCT number
- 2019-001043-41
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 196
- 8 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unacceptable toxicity with prior checkpoint inhibitor therapy
Other illness
- Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy
- Impaired heart function
Lab values
- Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions
Other
- Uncontrolled brain metastases
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Completed |
| Complejo Hospitalario Universitario Insular Materno Infantil Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Completed |
| Hospital Universitario Lucus Augusti Coordinator of this site? Confirm its status | Lugo | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Istituto Europeo di Oncologia s.r.l Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi Coordinator of this site? Confirm its status | Varese | Italy | Completed |
| Netherlands Cancer Institute Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.