問卷
Log In
繁中 EN
TPIDB
TPIDB Outstanding PI
TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol Number20190341
NCT Number(ClinicalTrials.gov Identfier)NCT05920356
Active

2023-07-31 - 2031-02-01

Phase III

Recruiting7

ICD-10C33

Malignant neoplasm of trachea

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.0

Malignant neoplasm of trachea

A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator JIN-YUAN SHIH Division of General Internal Medicine
National Taiwan University Hospital

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 Ping-Chih Hsu Division of General Internal Medicine
Linkou Chang Gung Medical Foundation

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 高婉真 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

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 Chien-Chung Lin Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-Small Cell Lung Cancer (NSCLC)

Objectives

This is a phase 3, international collaborative, multicenter, randomized, open-label trial of patients with stage IV or stage IIIB/C advanced nonsquamous, PD-L1-negative, KRAS p.G12C mutation-positive NSCLC. subjects, to evaluate the efficacy and safety of sotorasib in combination with carboplatin and pemetrexed versus pembrolizumab in combination with carboplatin and pemetrexed in an initial setting. main target: ‧ Comparison of progression-free survival (PFS) in subjects who received sotorasib plus platinum-based doublet chemotherapy versus those who received pembrolizumab plus platinum-based doublet chemotherapy. Major secondary goals: ‧ Comparing the objective response rate (ORR) of subjects who received sotorasib plus platinum-based doublet chemotherapy versus those who received pembrolizumab plus platinum-based doublet chemotherapy. ‧ Comparing overall survival (OS) of subjects who received sotorasib plus platinum-based doublet chemotherapy relative to subjects who received pembrolizumab plus platinum-based doublet chemotherapy. ‧ Compare patient self-reported outcomes (PRO) assessed with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire 30 Core Questions (QLQ-C30) and the Quality of Life Questionnaire 13 Lung Cancer Questions (QLQ-LC13) ‧ PFS2 is defined as the time from random assignment until the trial administrator determines that the disease has worsened after starting a new anticancer therapy Secondary goals: ‧ Comparing progression-free survival 2 (PFS2) in subjects who received sotorasib plus platinum-based doublet chemotherapy versus those who received pembrolizumab plus platinum-based doublet chemotherapy. ‧ Compare the effects of sotorasib plus platinum-based doublet chemotherapy versus pembrolizumab plus platinum-based doublet chemotherapy on other treatments and disease-related symptoms and health-related quality of life ‧ Comparing duration of response, time to response, and disease control in subjects who received sotorasib plus platinum-based doublet chemotherapy versus those who received pembrolizumab plus platinum-based doublet chemotherapy. ‧ Comparing PFS and objective response in subjects who received sotorasib plus platinum-based doublet chemotherapy versus those who received pembrolizumab plus platinum-based doublet chemotherapy, as assessed by the trial sponsor according to RECIST version 1.1 ‧ Compare the safety and tolerability of subjects who received sotorasib plus platinum-containing dual chemotherapy compared with subjects who received pembrolizumab plus platinum-containing dual chemotherapy. ‧ Explore the pharmacokinetics (PK) of sotorasib

Test Drug

sotorasib (AMG 510)Pembrolizumab

Active Ingredient

Sotorasib
Pembrolizumab

Dosage Form

Filmcoated Tablets
Injection

Dosage

120 mg
100mg/4mL

Endpoints

PFS was defined as the time from random assignment until first radiologically documented disease progression, or death from any cause, whichever occurred first. PFS will be limited to after the baseline point, otherwise the last tumor assessment after randomization. Exacerbation will be assessed by the Blinded Central Independent Review Committee (BICR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

Inclution Criteria

Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing
No history of systemic anticancer therapy in metastatic/non-curable settings
Eastern Cooperative Oncology Group (ECOG) ≤ 1

Exclusion Criteria

Exclusion Criteria:

Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology
Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved
Symptomatic (treated or untreated) brain metastases
Gastrointestinal (GI) tract disease causing the inability to take oral medication
Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina
Prior therapy with a KRAS G12C inhibitor

The Estimated Number of Participants

  • Taiwan

    22 participants

  • Global

    750 participants

聯絡我們

台灣臨床試驗主持人資料庫 TPIDB

All Contents Copyright 2020 台灣臨床試驗主持人資料庫TPIDB