Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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16 November 2020 |
Main ID: |
EUCTR2019-001043-41-GB |
Date of registration:
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17/08/2020 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
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Scientific title:
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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) |
Date of first enrolment:
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14/10/2020 |
Target sample size:
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532 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-001043-41 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Canada
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France
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Germany
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Hungary
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Israel
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Italy
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Netherlands
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Spain
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Vanessa Tassell
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Address:
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9393 Towne Centre Drive, Suite 200
CA 92121
San Diego
United States |
Telephone:
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Email:
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tassellv@mirati.com |
Affiliation:
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Mirati Therapeutics, Inc. |
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Name:
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Vanessa Tassell
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Address:
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9393 Towne Centre Drive, Suite 200
CA 92121
San Diego
United States |
Telephone:
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Email:
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tassellv@mirati.com |
Affiliation:
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Mirati Therapeutics, Inc. |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Diagnosis of Non-Squamous Non-Small Cell Lung Cancer 2. Receipt of at least one but not more than two prior treatment regimens in the advanced setting 3. 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) 4. Most recent treatment regimen must have included a checkpoint inhibitor therapy with radiographic disease progression on or after treatment 5. Candidate to receive docetaxel as second or third line therapy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 266 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 266
Exclusion criteria: 1. Uncontrolled brain metastases 2. Tumors that have tested positive for EGFR, ROS1, ALK mutations, or ALK fusions 3. Unacceptable toxicity with prior checkpoint inhibitor therapy 4. Receipt of systemic anti-cancer therapy post checkpoint inhibitor therapy, other than maintenance chemotherapy 5. Impaired heart function
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Non-Squamous Non-Small Cell Lung Cancer MedDRA version: 20.0
Level: LLT
Classification code 10079440
Term: Non-squamous non-small cell lung cancer
System Organ Class: 100000004864
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Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
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Intervention(s)
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Product Name: Sitravatinib Product Code: MGCD516 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Sitravatinib Current Sponsor code: MGCD516 malate Other descriptive name: Sitravatinib malate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 35-
Product Name: Sitravatinib Product Code: MGCD516 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Sitravatinib Current Sponsor code: MGCD516 malate Other descriptive name: Sitravatinib malate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-
Trade Name: Opdivo Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Nivolumab CAS Number: 946414-94-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10-
Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: DOCETAXEL CAS Number: 114977-28-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20-
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Primary Outcome(s)
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Primary end point(s): Overall Survival (OS)
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Secondary Objective: - To evaluate the safety of sitravatinib in combination with nivolumab in the study population. - To evaluate the relative tolerability of sitravatinib and nivolumab versus docetaxel. - To evaluate secondary efficacy endpoints in the study population. - To evaluate the pharmacokinetics (PK) of sitravatinib (MGCD516) administered in combination with nivolumab. - To evaluate health-related quality of life and lung cancer-specific symptoms in the study population.
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Main Objective: 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.
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Timepoint(s) of evaluation of this end point: primary analysis, interim analysis, and end of study
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: primary analysis, interim analysis, and end of study
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Secondary end point(s): 1. Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events, laboratory abnormalities, and number of patients discontinuing study treatment due to an adverse event. 2. Secondary efficacy endpoints: - Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). -Duration of Response (DOR); - Clinical Benefit Rate (CBR); - Progression-Free Survival (PFS); and - 1-Year Survival Rate. 3. Blood plasma concentrations of MGCD516. 4. Patient reported outcome (PROs): - Lung Cancer Symptom Scale (LCSS); and - European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).
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Secondary ID(s)
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2019-001043-41-FR
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516-005
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NCT03906071
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Source(s) of Monetary Support
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Mirati Therapeutics, Inc.
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Ethics review
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Status: Approved
Approval date: 14/10/2020
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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