Phase 2 Study of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab plus Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation

A Phase 2 Trial of Adagrasib Monotherapy and in Combination with Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination with Pembrolizumab versus Pembrolizumab plus Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer with KRAS G12C Mutation

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003101-58-HU

Enrollment

256

Registered

2022-02-23

Start date

2022-04-08

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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)

Interventions

Trade Name: KEYTRUDA Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Pembrolizumab CAS Number: 1374853-91-4 Concentration unit: mg/ml milligram(s)/millilitre Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS. 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 102 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 154

Exclusion criteria

Exclusion criteria: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510). Active brain metastases.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. ;Secondary Objective: •To characterize the safety and tolerability of the monotherapy and the combination regimen in the selected population. •To evaluate secondary efficacy endpoints using monotherapy and the combination regimen in the selected population. •To evaluate the pharmacokinetics (PK) of adagrasib administered as monotherapy and in combination with pembrolizumab. ;Primary end point(s): Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);Timepoint(s) of evaluation of this end point: 22 months	—

Measure

Time frame

Main Objective: To evaluate the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. ;Secondary Objective: •To characterize the safety and tolerability of the monotherapy and the combination regimen in the selected population. •To evaluate secondary efficacy endpoints using monotherapy and the combination regimen in the selected population. •To evaluate the pharmacokinetics (PK) of adagrasib administered as monotherapy and in combination with pembrolizumab. ;Primary end point(s): Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);Timepoint(s) of evaluation of this end point: 22 months

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Secondary

Measure	Time frame
Secondary end point(s): -Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities -Duration of Response (DOR), Progression - Free Survival (PFS), 1-Year Survival rate, Overall Survival (OS) - Pharmacokinetics (PK) Blood plasma MRTX849 and potential metabolite concentrations ;Timepoint(s) of evaluation of this end point: 22 months	—

Measure

Time frame

Secondary end point(s): -Safety characterized by type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and laboratory abnormalities -Duration of Response (DOR), Progression - Free Survival (PFS), 1-Year Survival rate, Overall Survival (OS) - Pharmacokinetics (PK) Blood plasma MRTX849 and potential metabolite concentrations ;Timepoint(s) of evaluation of this end point: 22 months

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Countries

Australia, Austria, Belgium, Bulgaria, Canada, China, Czechia, Czech Republic, France, Germany, Hungary, Ireland, Israel, Italy, Korea, Republic of, Netherlands, Poland, Portugal, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactMirati Study Locator Services

Mirati Therapeutics, Inc.

miratistudylocator@careboxhealth.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026