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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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut Catala d'Oncologia
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BadalonaSpainCompleted
Complejo Hospitalario Universitario Insular Materno Infantil
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Las Palmas de Gran CanariaSpainCompleted
Hospital Universitario Lucus Augusti
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LugoSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Fundación Instituto Valenciano de Oncología
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ValenciaSpainCompleted
Istituto Europeo di Oncologia s.r.l
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MilanItalyCompleted
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
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VareseItalyCompleted
Netherlands Cancer Institute
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AmsterdamNetherlandsCompleted

This page is information, not medical advice. Discuss any trial with your doctor.