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Clinical Trials List

Protocol Number849-007
NCT Number(ClinicalTrials.gov Identfier)NCT04613596
Active

2022-04-15 - 2029-10-31

Phase II/III

Recruiting8

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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 in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

  • Trial Applicant

    Pharmaceutical Research Associates Taiwan Inc.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林正耀 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳銘芳 無
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Cheng Chang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Te-Chun Hsia Division of General Internal Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Advanced Non-Small Cell Lung Cancer

Objectives

Issue 2 To evaluate the efficacy and safety of MRTX849 monotherapy and concomitantly with pembrolizumab in a cohort of patients with advanced NSCLC harboring KRAS G12C mutations and any PD-L1 TPS who are eligible for first-line treatment. Issue 3 To compare the efficacy of adagrasib plus pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic nonsquamous NSCLC, KRAS G12C mutation, and PD-L1 TPS >=50% who are candidates for first-line treatment.

Test Drug

MRTX849MRTX849KEYTRUDAKEYTRUDA

Active Ingredient

Adagrasib
Pembrolizumab

Dosage Form

Tablet
Tablet
Concentrate for solution for infusion
Concentrate for solution for infusion

Dosage

200 mg per tablet
25mg/mL

Endpoints

Issue 2
Main indicators
- Objective response rate (ORR) defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)
Secondary indicators
- Safety characteristics are the type, incidence, severity, timing, severity, and relationship to the trial treatment of adverse events and abnormal laboratory test results.
- Defined as the time from the first documented objective tumor response (CR or PR) to the first documented progressive disease (PD) or death from any cause, whichever occurs first.
- Defined as the time from the first trial treatment until disease progression or death from any cause, whichever occurs first.
- 1-year survival rate
- Overall survival (OS)
- Pharmacokinetics (PK) Plasma Adagrasib and Possible Metabolite Concentrations

Issue 3
Main indicators
- Progression-free survival (PFS) assessed by blinded independent central review (BICR)
Secondary indicators
- Safety characteristics are the type, incidence, severity, timing, severity, and relationship to the trial treatment of adverse events and laboratory abnormalities
- Pharmacokinetics (PK) Plasma Adagrasib and Possible Metabolite Concentrations
- Patient-reported outcomes for measuring quality of life
- Defined as the time elapsed from the date of first trial treatment to the date of death from any cause. It was defined as the time from the first trial treatment until disease progression or death from any cause, whichever occurred first.
- Defined as the time from the date of the first documented objective tumor response (CR or PR) to the date of the first documented progressive disease (PD) or death from any cause, whichever occurred first.

Inclution Criteria

Inclusion Criteria:

Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS
Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS >=50%
Phase 3: Presence of evaluable or measurable disease per RECIST
Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:

No evidence of brain metastases
Untreated brain metastases not needing immediate local therapy
Previously treated brain metastases not needing immediate local therapy

Exclusion Criteria

Exclusion Criteria:

Phase 2 and Phase 3: 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).
Phase 2: Active brain metastases
Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:

Any untreated brain lesions > 1.0 cm in size
Any brainstem lesions
Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of > 10 mg of prednisone (or equivalent) prior to randomization.
Have poorly controlled (> 1/week) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy
Phase 3: Radiation to the lung > 30 Gy within 6 months prior to the first dose of study treatment

The Estimated Number of Participants

  • Taiwan

    18 participants

  • Global

    545 participants

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