Clinical Trials List
2024-09-01 - 2032-12-31
Phase III
Recruiting5
ICD-10C19
Malignant neoplasm of rectosigmoid junction
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9154.0
Malignant neoplasm of rectosigmoid junction
A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer
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Trial Applicant
Johnson & Johnson
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/06/17
Investigators and Locations
Co-Principal Investigator
- Ying-Chun Shen 無
- 張端瑩 無
- 郭弘揚 無
- 李佳真 無
- Chih-Hung Hsu 無
- Chiun Hsu 無
- TA-CHEN HUANG 無
- 呂理駿 無
- YU-YUN SHAO 無
- 莊建淮 無
- 陳國興 無
- Ann-Lii Cheng 無
- 林宗哲 無
- 梁逸歆 無
- 陳柏邑 無
- TSUNG-HAO LIU 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 黃文冠 無
- Chia-Hsun Hsieh 無
- Wen-Chi Chou 無
- Jen-Shi Chen 無
- 賴盈傑 無
- 呂嘉偉 無
- Yung-Chia Kao 無
- Tsai-Sheng Yang 無
- Mengting Peng 無
- 余紹銘 無
- 張境夫 無
- 黃振洋 無
- Ming-Mo Hou 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Cetuximab
Dosage Form
270
Dosage
NA
Endpoints
Secondary Outcome Measure:
- Overall survival
- Objective response rate as assessed by the Blinded Central Independent Review Committee (BICR)
- Progression-free survival as assessed by the trial physician
- Duration of response as assessed by the Blinded Central Independent Review Committee (BICR)
- Duration of response as assessed by the trial physician
- Progression-free survival after next-line treatment
- Duration of disease control as assessed by the Blinded Central Independent Review Committee (BICR)
- Duration of disease control as assessed by the trial physician
- Time to treatment failure
- Proportion of curative resection
- Number of participants experiencing adverse events, categorized by severity
- Number of participants experiencing abnormal laboratory values
- Change in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) since baseline
- Time to symptom and functional deterioration as measured by the EORTC QLQ-C30
- European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC) Colorectal Cancer Unit 29 (EORTC) Changes in QLQ-C30 since baseline
- Time to symptom and functional deterioration as measured by EORTC QLQ-CR29
- Overall side effect load as measured by score on European Organisation for the Treatment and Research of Cancer (EORTC) Scale 168
Inclution Criteria
Have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. Participants must have unresectable or metastatic disease
Determined to have Kirsten rat sarcoma viral oncogene (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), and v-raf murine sarcoma viral oncogene homolog B (BRAF) wild-type (WT) tumor by local and/or central testing (if available)
Must agree to the submission of fresh tumor tissue
Have measurable disease according to RECIST v1.1
Has not received any prior systemic therapy for unresectable or metastatic colorectal cancer (CRC). Prior adjuvant/neoadjuvant therapy in the non-metastatic disease is permitted. However, the last course of adjuvant or neoadjuvant chemotherapy must have concluded greater than (>) 12 months prior to CRC recurrence/metastases
Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 or 1
Exclusion Criteria
Has medical history of (noninfectious) interstitial lung disease (ILD) /pneumonitis/pulmonary fibrosis or has current ILD/pneumonitis/pulmonary fibrosis, or where suspected ILD/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening
Has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or cetuximab, (b) any component of mFOLFOX6 and, (c) any component of FOLFIRI
Has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is likely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
Participant with known mismatch repair deficiency (dMMR)/ high microsatellite instability (MSI-H) status and human epidermal growth factor receptor 2 (HER2)-positive/amplified tumor
Has prior exposure to any agents that target epidermal growth factor receptor (EGFR), mesenchymal epithelial transition (MET) or vascular endothelial growth factor (VEGF)
The Estimated Number of Participants
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Taiwan
50 participants
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Global
1000 participants
