Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients WithAdvanced Non-Squamous Non-Small Cell Lung Cancer
- Conditions
- on-Squamous Non-Small Cell Lung CancerMedDRA version: 20.0Level: LLTClassification code 10079440Term: Non-squamous non-small cell lung cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2019-001043-41-IT
- Lead Sponsor
- MIRATI THERAPEUTICS INCORPORATED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 532
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;Secondary Objective: - To evaluate the safety of sitravatinib in combination with nivolumab in the study population.<br>- To evaluate the relative tolerability of sitravatinib and nivolumab versus docetaxel.<br>- To evaluate secondary efficacy endpoints in the study population.<br>- To evaluate the pharmacokinetics (PK) of sitravatinib (MGCD516) administered in combination with nivolumab.<br>- To evaluate health-related quality of life and lung cancer-specific symptoms in the study population.;Primary end point(s): Overall Survival (OS);Timepoint(s) of evaluation of this end point: primary analysis, interim analysis, and end of study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Safety characterized by type, incidence, severity, timing, seriousness<br>and relationship to study treatment of adverse events, laboratory<br>abnormalities, and number of patients discontinuing study treatment<br>due to an adverse event.<br>2. Secondary efficacy endpoints:<br>- Objective Response Rate (ORR) as defined by Response Evaluation<br>Criteria in Solid Tumors version 1.1 (RECIST 1.1).<br>-Duration of Response (DOR);<br>- Clinical Benefit Rate (CBR);<br>- Progression-Free Survival (PFS); and<br>- 1-Year Survival Rate.<br>3. Blood plasma concentrations of MGCD516.<br>4. Patient reported outcome (PROs):<br>- Lung Cancer Symptom Scale (LCSS); and<br>- European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).;Timepoint(s) of evaluation of this end point: primary analysis, interim analysis, and end of study