Advanced Non-Small Cell Lung Cancer MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Code: MRTX849
Pharmaceutical Form: Tablet
INN or Proposed INN: Adagrasib
CAS Number: 2326521-71-3
Current Sponsor code: MRTX849
Other descriptive name: MRTX849
Concentration unit: mg milligram
Sponsors
Mirati Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation. • Candidacy to receive treatment with docetaxel. Crossover inclusion criteria 1. Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR 2. EGOG performance status 0-2. 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 225 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 225
Exclusion criteria
Exclusion criteria: • Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, sotorasib). • Active brain metastases. Crossover Exclusion Criteria: 1. Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation. ;Secondary Objective: • To evaluate secondary efficacy endpoints in the study population. • To evaluate the safety and tolerability in the study population. • To evaluate the pharmacokinetics (PK) of MRTX849 administered in the study population. • To evaluate health-related quality of life (HRQOL) and lung cancer-specific symptoms in the study population. ;Primary end point(s): - Progression-free Survival (PFS) Defined as time from randomization until disease progression or death from any cause, whichever occurs first. ;Timepoint(s) of evaluation of this end point: PFS-32 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints: - Overall Survival (OS) - Objective Response Rate (ORR), - Duration of Response (DOR), and - 1-Year Survival Rate. • Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events (AEs), laboratory abnormalities, and number of patients discontinuing study treatment due to an adverse event. • Population PK parameters of MRTX849. • Patient Reported Outcome (PRO) scores using the following: - Lung Cancer Symptom Scale (LCSS), and - European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L - Duration of Response (DOR), and - 1-Year Survival Rate. • Plasma PK parameters of MRTX849 (and metabolites, if applicable). • Patient Reported Outcome (PRO) scores using the following: - Lung Cancer Symptom Scale (LCSS), and - European Quality of Life Five Dimensions Questionnaire (EQ-5D-5L).;Timepoint(s) of evaluation of this end point: 32 months (Primary efficacy endpoint PFS and Secondary efficacy endpoint ORR) and 49 months (all other secondary endpoints) | — |
Countries
Australia, Austria, Belgium, Chile, China, Costa Rica, Czechia, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Korea, Republic of, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Singapore, Spain, Switzerland, United Kingdom, United States
Contacts
Public ContactMirati Study Locator Services
Mirati Therapeutics, Inc.
Outcome results
None listed