Clinical Trials List
Protocol NumberU31402-A-U301
2022-05-10 - 2026-08-04
Phase III
Not yet recruiting1
Recruiting5
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
HERTHENA–Lung02: A Phase 3, Randomized, Open-label Study of Patritumab Deruxtecan Versus Platinum based Chemotherapy in Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC) After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy
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Trial Applicant
Daiichi Sankyo Taiwan Ltd.
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Sponsor
Daiichi Sankyo, Inc
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Trial scale
Multi-Regional Multi-Center
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Update
2025/11/06
Investigators and Locations
Co-Principal Investigator
- Shang-Yin Wu Division of Hematology & Oncology
- Seu-Chun Yang Division of General Internal Medicine
- Jui-Hung Tsai Division of Hematology & Oncology
- 蔡政軒 Division of General Internal Medicine
- Yu-Min Yeh Division of Hematology & Oncology
- Po-Lan Su Division of General Internal Medicine
- Yi-Ting Yen Division of General Surgery
- Wu-Chou Su Division of Hematology & Oncology
- Chun-Hui Lee Division of Hematology & Oncology
- Chian-Wei Chen Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Hsu-ching Huang 無
- YEN-HAN TSENG 無
- Chi-Lu Chiang 無
- Chia-I Shen 無
- Heng-Sheng Chao 未分科
- 趙恒勝 無
- 蕭慈慧 無
- 張毓帆 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 廖斌志 無
- JIN-YUAN SHIH 無
- 許嘉林 無
- 魏以宣 無
- 徐偉勛 無
- 陳冠宇 無
- 蔡子修 無
- Jih-Hsiang Lee 無
- 林宗哲 無
- Chong-Jen Yu 無
- 廖唯昱 無
- 吳尚俊 無
- Chia-Chi Lin 無
- WEI-LI MA 無
- CHAO-CHI HO CHAO-CHI HO 無
- 楊景堯 無
- YEN-TING LIN 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Hung Chen 無
- 枋岳甫 無
- 陳宏吉 無
- Chih-Hsi Kuo 無
- Ping-Chih Hsu 無
- 邱立忠 無
- Chien-Ying Liu 無
- 黃宗楨 無
- Jia-Shiuan Ju 無
- Cheng-Ta Yang 無
- 柯皓文 無
- 黃繼賢 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
TSUNG -YING YANG
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Non-small cell lung cancer
Objectives
This is a global, multicenter, open-label, randomized, phase 3 trial designed to evaluate the efficacy and safety of patritumab deruxtecan compared to platinum-based therapy plus pemetrexed in patients with metastatic or locally advanced non-squamous NSCLC who have EGFR activating mutations (exon 19 deletion or L858R), have received one or two lines of EGFR TKI therapy (including third-generation EGFR TKIs [e.g., osimertinib, lazertinib, aumoletinib, alflutinib]), and whose disease has progressed during or after treatment with a third-generation EGFR TKI.
Test Drug
Patritumab Deruxtecan (U3-1402)
Active Ingredient
Patritumab Deruxtecan
Dosage Form
048
Dosage
20 mg/ml
Endpoints
Primary: To compare the efficacy of patritumab deruxtecan versus platinum-based chemotherapy as measured by progression-free survival (PFS) in patients with metastatic or locally advanced non-squamous NSCLC harboring EGFR activating mutations (exon 19 deletion or L858R).
Secondary: To compare the efficacy of patritumab deruxtecan versus platinum-based chemotherapy as measured by overall survival (OS) in patients with metastatic or locally advanced non-squamous NSCLC harboring EGFR activating mutations (exon 19 deletion or L858R).
Secondary: To compare the efficacy of patritumab deruxtecan versus platinum-based chemotherapy as measured by overall survival (OS) in patients with metastatic or locally advanced non-squamous NSCLC harboring EGFR activating mutations (exon 19 deletion or L858R).
Inclution Criteria
Primary Inclusion Criteria:
1. Male or female participants aged >18 years (if the statutory age of consent for trial participation is >18 years, please comply with local regulations).
2. Patients with histologically or cytologically confirmed metastatic or locally advanced non-squamous NSCLC who are not suitable for curative surgery or radiation therapy.
3. Evidence of EGFR activating mutations (exon 19 deletion or L858R) detected in tumor tissue or blood samples at or after diagnosis.
4. Patients in a metastatic or locally advanced state who have received one or two lines of approved EGFR TKI therapy, including at least one third-generation EGFR TKI.
5. Patients who may have previously received lead and/or adjuvant therapy and progressed to metastatic or locally advanced disease at least 12 months after the last dose of such therapy, and subsequently experienced disease progression during or after treatment with a third-generation EGFR TKI in a metastatic or locally advanced state.
6. Has not received any other systemic therapy (including chemotherapy, immunotherapy, etc.) in metastatic or locally advanced settings (even in combination with EGFR TKIs).
7. Has evidence of radiographic disease progression during or after treatment with a third-generation EGFR TKI for metastatic or locally advanced disease.
8. Has at least one measurable lesion as assessed by the trial administrator according to RECIST v1.1.
9. Willing to provide sufficient quantity and quality of tumor tissue contents.
10. Has an ECOG PS score of 0 or 1 at the time of screening.
11. Based on local laboratory data for the following items within 14 days prior to randomization, candidates must have adequate bone marrow reserves and organ function:
‧ Platelet count / ≤100,000/mm3 or ≤100 x 109/L (within 14 days prior to platelet assessment during screening)
‧ Absolute neutrophil count / ≤1500/mm3 or ≤1.5 x 109/L (within 14 days prior to absolute neutrophil assessment during screening)
‧ Heme / ≤9.0 g/dL (within 14 days prior to heme assessment during screening)
‧ CrCl / CrCl ≤45 mL/min, calculated using the Cockcroft-Gault formula or CrCl measurements.
• AST/ALT / AST/ALT ≤ 3 times ULN
• TBL / TBL ≤ 1.5 times ULN
• Serum albumin / ≤ 2.5 g/dL
• PT or PT-INR and aPTT/PTT / ≤ 1.5 times ULN, except for subjects receiving coumarin-derived anticoagulants or other similar anticoagulant therapies, whose PT-INR must be within the range deemed appropriate by the trial administrator.
1. Male or female participants aged >18 years (if the statutory age of consent for trial participation is >18 years, please comply with local regulations).
2. Patients with histologically or cytologically confirmed metastatic or locally advanced non-squamous NSCLC who are not suitable for curative surgery or radiation therapy.
3. Evidence of EGFR activating mutations (exon 19 deletion or L858R) detected in tumor tissue or blood samples at or after diagnosis.
4. Patients in a metastatic or locally advanced state who have received one or two lines of approved EGFR TKI therapy, including at least one third-generation EGFR TKI.
5. Patients who may have previously received lead and/or adjuvant therapy and progressed to metastatic or locally advanced disease at least 12 months after the last dose of such therapy, and subsequently experienced disease progression during or after treatment with a third-generation EGFR TKI in a metastatic or locally advanced state.
6. Has not received any other systemic therapy (including chemotherapy, immunotherapy, etc.) in metastatic or locally advanced settings (even in combination with EGFR TKIs).
7. Has evidence of radiographic disease progression during or after treatment with a third-generation EGFR TKI for metastatic or locally advanced disease.
8. Has at least one measurable lesion as assessed by the trial administrator according to RECIST v1.1.
9. Willing to provide sufficient quantity and quality of tumor tissue contents.
10. Has an ECOG PS score of 0 or 1 at the time of screening.
11. Based on local laboratory data for the following items within 14 days prior to randomization, candidates must have adequate bone marrow reserves and organ function:
‧ Platelet count / ≤100,000/mm3 or ≤100 x 109/L (within 14 days prior to platelet assessment during screening)
‧ Absolute neutrophil count / ≤1500/mm3 or ≤1.5 x 109/L (within 14 days prior to absolute neutrophil assessment during screening)
‧ Heme / ≤9.0 g/dL (within 14 days prior to heme assessment during screening)
‧ CrCl / CrCl ≤45 mL/min, calculated using the Cockcroft-Gault formula or CrCl measurements.
• AST/ALT / AST/ALT ≤ 3 times ULN
• TBL / TBL ≤ 1.5 times ULN
• Serum albumin / ≤ 2.5 g/dL
• PT or PT-INR and aPTT/PTT / ≤ 1.5 times ULN, except for subjects receiving coumarin-derived anticoagulants or other similar anticoagulant therapies, whose PT-INR must be within the range deemed appropriate by the trial administrator.
Exclusion Criteria
Exclusion Criteria:
1. Any prior histological or cytological evidence of small cell or mixed small cell/non-small cell disease, or squamous NSCLC histological morphology, in stock tumor tissue or pre-treatment tumor sections.
2. Any history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis), current ILD, or suspected ILD based on contrast imaging during screening.
3. Clinically severe respiratory failure due to concomitant lung disease (based on the trial administrator's assessment), including but not limited to:
* Any pre-existing lung disease, focal lung disease, or pleural effusion
* Any autoimmune, connective tissue, or inflammatory disease (e.g., rheumatoid arthritis, Hughes syndrome, and sarcomatoid disease) with evidence of or suspected lung involvement at screening. For subjects with such diseases but without evidence of lung involvement, detailed information about the disease should be recorded on the electronic case report (eCRF) of the enrolled subjects. 4. Or previously underwent total pneumonectomy.
5. Currently receiving chronic systemic corticosteroids at doses greater than >10 mg prednisone or equivalent anti-inflammatory activity, or any form of immunosuppressive therapy prior to randomization.
6. History of any leptomeningeal disease or current evidence of leptomeningeal disease.
7. Evidence of clinically active spinal cord compression or brain metastases, defined as symptomatic and untreated, or requiring corticosteroids or antiepileptic drugs to control related symptoms.
8. Previously received the following treatments:
Any antibody-drug complex (ADC) formulation containing an antibody that acts on a type I topoisomeric chemotherapy drug.
Human epidermal growth factor receptor 3 (HER3) antibody.
Any systemic therapy (excluding EGFR TKIs) in metastatic/locally advanced settings, including chemotherapy or any other systemic therapy concomitant with EGFR TKIs. 8. History of other active malignancies within 3 years prior to randomization, except for:
. Well-resected non-melanoma skin cancer.
. Well-treated cervical intraepithelial carcinoma.
. Any other in situ disease that has received curative therapy.
9. Poorly controlled or significant cardiovascular disease prior to randomization.
10. Active hepatitis B and/or hepatitis C infection, such as serological evidence of active viral infection within 28 days of randomization.
11. Known uncontrolled human immunodeficiency virus (HIV) infection.
12. Clinically significant corneal disease.
1. Any prior histological or cytological evidence of small cell or mixed small cell/non-small cell disease, or squamous NSCLC histological morphology, in stock tumor tissue or pre-treatment tumor sections.
2. Any history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis), current ILD, or suspected ILD based on contrast imaging during screening.
3. Clinically severe respiratory failure due to concomitant lung disease (based on the trial administrator's assessment), including but not limited to:
* Any pre-existing lung disease, focal lung disease, or pleural effusion
* Any autoimmune, connective tissue, or inflammatory disease (e.g., rheumatoid arthritis, Hughes syndrome, and sarcomatoid disease) with evidence of or suspected lung involvement at screening. For subjects with such diseases but without evidence of lung involvement, detailed information about the disease should be recorded on the electronic case report (eCRF) of the enrolled subjects. 4. Or previously underwent total pneumonectomy.
5. Currently receiving chronic systemic corticosteroids at doses greater than >10 mg prednisone or equivalent anti-inflammatory activity, or any form of immunosuppressive therapy prior to randomization.
6. History of any leptomeningeal disease or current evidence of leptomeningeal disease.
7. Evidence of clinically active spinal cord compression or brain metastases, defined as symptomatic and untreated, or requiring corticosteroids or antiepileptic drugs to control related symptoms.
8. Previously received the following treatments:
Any antibody-drug complex (ADC) formulation containing an antibody that acts on a type I topoisomeric chemotherapy drug.
Human epidermal growth factor receptor 3 (HER3) antibody.
Any systemic therapy (excluding EGFR TKIs) in metastatic/locally advanced settings, including chemotherapy or any other systemic therapy concomitant with EGFR TKIs. 8. History of other active malignancies within 3 years prior to randomization, except for:
. Well-resected non-melanoma skin cancer.
. Well-treated cervical intraepithelial carcinoma.
. Any other in situ disease that has received curative therapy.
9. Poorly controlled or significant cardiovascular disease prior to randomization.
10. Active hepatitis B and/or hepatitis C infection, such as serological evidence of active viral infection within 28 days of randomization.
11. Known uncontrolled human immunodeficiency virus (HIV) infection.
12. Clinically significant corneal disease.
The Estimated Number of Participants
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Taiwan
36 participants
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Global
560 participants
