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
Conditions
Sponsors
Mirati Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. - 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.;Primary end point(s): Overall Survival (OS);Timepoint(s) of evaluation of this end point: primary analysis, interim analysis, and end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| 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).;Timepoint(s) of evaluation of this end point: primary analysis, interim analysis, and end of study | — |
Countries
Belgium, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactVanessa Tassell
Mirati Therapeutics, Inc.
Outcome results
None listed