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)

  • STATUS
    Recruiting
Updated on 23 April 2021
cancer
lung cancer
experimental drug
docetaxel
nivolumab
cancer chemotherapy
platinum-based chemotherapy
advanced lung cancer
lung carcinoma
squamous non-small cell lung cancer
non-squamous non-small cell lung cancer
advanced non-squamous non-small cell lung cancer

Summary

This is an open-label, randomized (1:1), multicenter, Phase 3 clinical trial evaluating the safety and efficacy of nivolumab in combination with investigational agent sitravatinib compared to docetaxel in patients with advanced non-squamous NSCLC who have previously experienced radiographic disease progression on or after treatment with platinum-based chemotherapy in combination with CIT.

Description

Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs, including the TAM family (TYRO3, AXL and MERTK), VEGFR2, KIT and MET.

Nivolumab is a human IgG monoclonal antibody that binds to the PD-1 receptor and selectively blocks the interaction with its ligands PD-L1 and PD-L2, thereby releasing PD-1 pathway mediated inhibition of the immune response, including anti-tumor immune response.

RTKs have been implicated in mediating an immunosuppressive tumor microenvironment, which has emerged as a potential resistance mechanism to checkpoint inhibitor therapy.

Inhibition of these RTKs by sitravatinib may augment anti-tumor immune response and improve outcomes by overcoming resistance to checkpoint inhibitor therapy.

Details
Condition Non-Small Cell Lung Cancer, Lung Cancer
Clinical Study IdentifierTX223045
Last Modified on23 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Lung Cancer?
Diagnosis of Non-Squamous Non-Small Cell Lung Cancer
Receipt of prior first-line treatment with platinum-based chemotherapy in combination with PD-1/PD-L1 checkpoint inhibitor therapy
Adequate bone marrow and organ function
Candidate to receive docetaxel as second 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 in the first-line setting
Impaired heart function
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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