Clinical Trials List
Protocol NumberC5851005
NCT Number(ClinicalTrials.gov Identfier)NCT07144280
Not yet recruiting
2025-09-01 - 2033-05-31
Phase III
Recruiting6
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
PADL1NK-005: A Randomized, Phase 3, Open-Label Study to Evaluate PF-08046054/SGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/04/10
Investigators and Locations
Co-Principal Investigator
- 廖映庭 Division of Thoracic Medicine
- 蕭慈慧 Division of Thoracic Medicine
- Hsu-ching Huang Division of Thoracic Medicine
- Yuh-Min Chen Division of Thoracic Medicine
- 趙恒勝 Division of Thoracic Medicine
- Chi-Lu Chiang Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- James Chih-Hsin Yang Division of General Internal Medicine
- 吳尚俊 Division of General Internal Medicine
- 廖唯昱 Division of General Internal Medicine
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
- 徐偉勛 Division of General Internal Medicine
- 黃俊凱 Division of General Internal Medicine
- 陳冠宇 Division of General Internal Medicine
- 楊景堯 Division of General Internal Medicine
- YEN-TING LIN Division of General Internal Medicine
- 蔡子修 Division of General Internal Medicine
- 許嘉林 Division of General Internal Medicine
- Jih-Hsiang Lee Division of General Internal Medicine
- 廖斌志 Division of General Internal Medicine
- 錢穎群 Division of General Internal Medicine
- Chia-Chi Lin Division of General Internal Medicine
- Chong-Jen Yu Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- KUO-HSUAN HSU Division of Thoracic Medicine
- 李柏昕 Division of Thoracic Medicine
- YEN-HSIANG HUANG Division of Thoracic Medicine
- JENG-SEN TSENG Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 紀炳銓 Division of General Internal Medicine
- 詹博強 Division of General Internal Medicine
- 陳正雄 Division of General Internal Medicine
- 林明泰 Division of General Internal Medicine
- 林慶雄 Division of General Internal Medicine
- 黃國揚 Division of General Internal Medicine
- 蔡偉宏 Division of General Internal Medicine
- 葉金水 Division of General Internal Medicine
- 施穎銘 Division of General Internal Medicine
- 林俊維 Division of General Internal Medicine
- 張時榮 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 李岱晃 Division of General Internal Medicine
- 郭家佑 Division of General Internal Medicine
- Inn-Wen Chong Division of General Internal Medicine
- 莊政皓 Division of General Internal Medicine
- Chih-Jen Yang Division of General Internal Medicine
- 李玫萱 Division of General Internal Medicine
- Ying-Ming Tsai Tsai Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chien-Chung Lin
Co-Principal Investigator
- Chian-Wei Chen Division of General Internal Medicine
- Po-Lan Su Division of General Internal Medicine
- Yu-Min Yeh Division of General Internal Medicine
- Chun-Hui Lee Division of General Internal Medicine
- Chin-Wei Kuo Division of General Internal Medicine
- Seu-Chun Yang Division of General Internal Medicine
- Shang-Yin Wu Division of General Internal Medicine
- 林建佑 Division of General Internal Medicine
- Wu-Chou Su Division of General Internal Medicine
- 蔡政軒 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Non-small Cell Carcinoma、 Non-Small Cell Lung Cancer Metastatic、 Non-Small Cell Lung Carcinoma
Objectives
A trial to understand the efficacy of the investigational drug PF-08046054/SGN-PDL1V compared to Docetaxel in adult participants with previously treated programmed death-ligand 1 (PD-L1)-positive non-small cell lung cancer (NSCLC).
Test Drug
Injectables
Active Ingredient
PF-08046054 (SGN-PDL1V)
DOCETAXEL
DOCETAXEL
Dosage Form
270
270
270
Dosage
40 mg
20 mg/mL
20 mg/mL
Endpoints
• Overall survival (OS)
• Progression-free survival (PFS) assessed by BICR using the Solid Tumor Response Assessment Standard version 1.1 (RECIST v1.1).
• Progression-free survival (PFS) assessed by BICR using the Solid Tumor Response Assessment Standard version 1.1 (RECIST v1.1).
Inclution Criteria
Inclusion Criteria
Histologically or cytologically confirmed diagnosis of NSCLC with locally advanced, unresectable Stage IIIB or IIIC not eligible for definitive chemoradiotherapy or metastatic (Stage IV: M1a, M1b, or M1c) disease per the American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer Control (UICC) Staging System. Note: Participants with a neuroendocrine component or histology are not eligible.
PD-L1 expression on ≥1% of tumor cells based on local immunohistochemistry (IHC) testing with an assay utilizing the anti-PD-L1 monoclonal antibody clones 22C3 or SP263.
Participants who have NSCLC with known AGAs are permitted.
Able to provide any of the following tumor tissues for biomarker analysis:
Archival specimen (preferably collected within 12 months after the last anticancer therapy) (see laboratory manual for details); or
De novo biopsy from a tumor lesion, if medically feasible.
Participants must have received the following therapies and progressed during or relapsed after receiving their most recent prior therapy, or have been intolerant to their most recent therapy:
Participants with no known AGAs must fulfill 1 of the following conditions:
Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, and unless contraindicated, a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting and received a PD-(L)1 monoclonal antibody at any time during the course of treatment.
Participants with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations) must fulfill the following conditions:
Must have received at least 1 relevant AGA-targeted therapy if locally available and, in the opinion of the investigator, additional AGA-targeted therapy is not in the best interest of the participant
Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting.
May have received PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
Histologically or cytologically confirmed diagnosis of NSCLC with locally advanced, unresectable Stage IIIB or IIIC not eligible for definitive chemoradiotherapy or metastatic (Stage IV: M1a, M1b, or M1c) disease per the American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer Control (UICC) Staging System. Note: Participants with a neuroendocrine component or histology are not eligible.
PD-L1 expression on ≥1% of tumor cells based on local immunohistochemistry (IHC) testing with an assay utilizing the anti-PD-L1 monoclonal antibody clones 22C3 or SP263.
Participants who have NSCLC with known AGAs are permitted.
Able to provide any of the following tumor tissues for biomarker analysis:
Archival specimen (preferably collected within 12 months after the last anticancer therapy) (see laboratory manual for details); or
De novo biopsy from a tumor lesion, if medically feasible.
Participants must have received the following therapies and progressed during or relapsed after receiving their most recent prior therapy, or have been intolerant to their most recent therapy:
Participants with no known AGAs must fulfill 1 of the following conditions:
Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, and unless contraindicated, a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting and received a PD-(L)1 monoclonal antibody at any time during the course of treatment.
Participants with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations) must fulfill the following conditions:
Must have received at least 1 relevant AGA-targeted therapy if locally available and, in the opinion of the investigator, additional AGA-targeted therapy is not in the best interest of the participant
Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting.
May have received PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
Exclusion Criteria
Exclusion Criteria
History of another malignancy within 3 years before the first dose of PF-08046054, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year overall survival [OS] ≥90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
Any central nervous system (CNS) lesions, unless definitively treated with CNS-directed local therapy (surgery and/or radiotherapy). Participants with definitively treated brain metastases are eligible if they meet the following criteria:
The participant is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least >14 days prior to randomization (if requiring steroid treatment).
No clinical or radiographic progression in the CNS following CNS-directed definitive radiotherapy and/or surgery.
Time since CNS-directed treatment is ≥28 days prior to randomization.
Participants with a history of leptomeningeal metastasis are excluded.
Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within 5 half-lives.
Previous receipt of an MMAE-containing agent or prior docetaxel.
History of another malignancy within 3 years before the first dose of PF-08046054, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year overall survival [OS] ≥90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.
Any central nervous system (CNS) lesions, unless definitively treated with CNS-directed local therapy (surgery and/or radiotherapy). Participants with definitively treated brain metastases are eligible if they meet the following criteria:
The participant is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least >14 days prior to randomization (if requiring steroid treatment).
No clinical or radiographic progression in the CNS following CNS-directed definitive radiotherapy and/or surgery.
Time since CNS-directed treatment is ≥28 days prior to randomization.
Participants with a history of leptomeningeal metastasis are excluded.
Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within 5 half-lives.
Previous receipt of an MMAE-containing agent or prior docetaxel.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
680 participants
