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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

A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY TO EVALUATE PF-08046054/SGN-PDLlV VERSUS DOCETAXEL IN ADULT PARTICIPANTS WITH PREVIOUSLY-TREATED PROGRAMMED CELL DEATH LIGAND 1 (PD-Ll) POSITIVE NON-SMALL-CELL LUNG CANCER (NSCLC)

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Yung-Hung Luo Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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 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 林聖皓 Division of General Internal Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

  • 紀炳銓 Division of General Internal Medicine
  • 詹博強 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
  • 陳正雄 Division of General Internal Medicine
  • 林明泰 Division of General Internal Medicine
  • 林慶雄 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

Principal Investigator Jen-Yu Hung Division of General Internal Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin
National Taiwan University Hospital

Co-Principal Investigator

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

Dosage Form

270
270

Dosage

40 mg
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).

Inclution Criteria

Inclusion Criteria

Histologically or cytologically confirmed diagnosis of locally advanced, unresectable Stage IIIB and IIIC not eligible for definitive chemoradiotherapy or metastatic (Stage IV: M1a, M1b, or M1c) NSCLC 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 (eg, estimated glomerular filtration rate (EGFR) mutations, anaplastic lymphoma kinase (ALK) translocations).
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
Fresh tissue 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:

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.
Active central nervous system (CNS) lesions are excluded. Active is defined as untreated or symptomatic requiring corticosteroids >10 mg/day of prednisone equivalent within the previous 14 days.

Participants with clinically inactive, definitively treated brain metastases (surgery and/or radiotherapy) 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 (if requiring steroid treatment).
No evidence of clinical and radiographic disease progression in the CNS for ≥28 days after definitive radiotherapy and/or surgery.
The use of corticosteroids at higher dose occurring ≥28 days prior to the Screening visit unless it is intermittent use for other medical conditions and allowed as a concomitant therapy.
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 Monomethyl auristatin E (MMAE)-containing agent or prior docetaxel.

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    680 participants

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