Phase 3 Study of MRTX849 vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

• Register: EUCTR
• Last refreshed on: 28 June 2021
• Main ID: EUCTR2020-003645-11-GR
• Date of registration: 27/05/2021
• Prospective Registration: Yes
• Primary sponsor: Mirati Therapeutics, Inc.
• Public title: Phase 3 Study of MRTX849 vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
• Scientific title: A Randomized Phase 3 Study of MRTX849 Versus Docetaxel in Patients With Previously Treated Non-Small Cell Lung Cancer With KRAS G12C Mutation
• Date of first enrolment: 25/06/2021
• Target sample size: 452
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-003645-11
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: no; 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Austria, Belgium, Czechia, 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

• Name: Mirati Study Locator Services
• Affiliation: Mirati Therapeutics, Inc.

• Name: Mirati Study Locator Services
• Affiliation: Mirati Therapeutics, Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
• Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
• Candidacy to receive treatment with docetaxel.
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 226
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 226

Exclusion criteria:
• Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510).
• Active brain metastases.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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)

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

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(s)
Concentration type: equal
Concentration number: 200-

Trade Name: Docetaxel Ribosepharm 80 mg/4 ml
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-

Primary Outcome(s)

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.

Primary end point(s): - Overall Survival (OS)
- Progression-free Survival (PFS)

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.

Timepoint(s) of evaluation of this end point: 30 months

Secondary Outcome(s)

Secondary end point(s): - Number of patients with treatment emergent AEs
- Objective Response Rate (ORR)
- Duration of Response (DOR)
- Patient Reported Outcomes (PROs)
- Quality of Life Assessment
- Blood plasma MRTX849 and potential metabolite concentrations

Timepoint(s) of evaluation of this end point: 30 Months

Secondary ID(s)

849-012

NCT04685135

Source(s) of Monetary Support

Mirati Therapeutics, Inc.

Ethics review

Status: Approved
Approval date: 17/06/2021
Contact: