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Clinical Trials List

Protocol NumberC5751003
NCT Number(ClinicalTrials.gov Identfier)NCT06758401
Active

2025-08-20 - 2029-02-17

Phase III

Recruiting8

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

AN OPEN-LABEL, RANDOMIZED, CONTROLLED PHASE 3 STUDY OF SIGVOTATUG VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB COMPARED WITH PEMBROLIZUMAB MONOTHERAPY AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH PD-L1 HIGH (≥50% OF TUMOR CELLS EXPRESSING PD-L1), LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC NON-SMALL CELL LUNG CANCER (BE6A LUNG-02)

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 黃文聰 無
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Hung Luo 無
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHIN-CHOU WANG 無
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang 無
National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Chi Lin 無
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG 無
Taichung Veterans General 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 Lung Cancer、 Carcinoma, Non-Small-Cell Lung 、Carcinoma, Non-Small-Cell Lung (NSCLC)

Objectives

Sigvotatug Vedotin plus Pembrolizumab, compared to Pembrolizumab monotherapy, was indicated as first-line treatment for participants with locally advanced, unresectable, or metastatic non-small cell lung cancer who exhibited high PD-L1 expression (≥50% of tumor cells expressing PD-L1).

Test Drug

Frozen Crystal Injection
Injection

Active Ingredient

Sigvotatug vedotin (PF-08046047 / SGN-B6A)
1013005400

Dosage Form

243
270

Dosage

30 mg
100 mg/4 mL

Endpoints

1. OS
2. BICR PFS

Inclution Criteria

Inclusion Criteria:

Participants must meet the following criteria:

Have pathologically confirmed Stage IIIB or IIIC NSCLC and not be a candidate for surgical resection or definitive chemoradiation, or Stage IV NSCLC per the AJCC Staging Manual (Version 8.0) and the UICC Staging System (Eighth edition).
Participants with non-squamous histology must have documented negative test results for EGFR, ALK, and ROS1 AGAs and no known AGAs in NTRK, BRAF, RET, MET, or other AGAs with approved front-line therapies per local standard of care.
Large cell neuroendocrine carcinoma is excluded.
Candidate for treatment with pembrolizumab monotherapy per local guidelines.
Tumor has PD-L1 expression in ≥50% of tumor cells (TPS ≥50%) as determined by local testing
Measurable disease based on RECIST v1.1 per investigator.
Resolution of acute effects of any prior therapy to either baseline severity or NCI CTCAE Grade 1 or less (except for AEs not constituting a safety risk in the investigator's judgment), unless otherwise excluded.

Exclusion Criteria

Exclusion Criteria:

Life expectancy of <3 months in the opinion of the investigator.
Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.
Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.
Known or suspected hypersensitivity, intolerance, or contraindication to any excipient contained in the drug formulation of sigvotatug vedotin or pembrolizumab.
Participants with any of the following respiratory conditions:

Evidence of noninfectious or drug-induced ILD or pneumonitis
Known DLCO (adjusted for hemoglobin) <50% predicted.
Grade ≥3 pulmonary disease unrelated to underlying malignancy
Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and/or radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter <0.5 cm are permitted.
Major surgery (defined as a surgery requiring inpatient hospitalization of at least 48 hours) within 21 days or minor surgery within 7 days prior to first dose of study intervention.
Receipt of a live vaccine within 30 days prior to first dose of study intervention.
Pre-existing peripheral neuropathy Grade ≥2 per NCI CTCAE v5.0.
Uncontrolled diabetes mellitus, defined as HbA1c ≥8.0% or HbA1c between 7.0% and 8.0% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, required a high-dose steroid taper (≥0.5 mg/kg prednisone or equivalent per day) for >2 weeks, or required treatment with systemic immunosuppressive therapy.
History of autoimmune disease that has required systemic treatment in the past 2 years
Participants with prior solid organ or bone marrow transplantation.
Currently receiving a high-dose steroid (>10 mg prednisone or equivalent per day) or other immune suppressant or has a condition requiring a chronic high-dose steroid or immune suppressant.
Prior and concomitant therapy:

Any prior treatment with MMAE-derived drugs or IB6 targeting agents.
Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC.

(Neo)adjuvant anti-PD-(L)1 is allowed if recurrence or progression occurred ≥9 months after the last dose.
Other (neo)adjuvant or definitive therapy is allowed if recurrence or progression occurred ≥6 months after the last dose.
Prior radiotherapy to the lung within 6 months of first dose of study intervention, referencing the last date radiotherapy was received.
Chemotherapy, biologics, and/or other antitumor treatment with immunotherapy not specifically prohibited that is completed less than 4 weeks prior to first dose of study intervention, or 2 weeks for palliative radiotherapy.
Any prior therapy with an immune-oncology agent directed to a stimulatory or co-inhibitory T-cell receptor
History of or current ongoing infection, including participants positive for active HIV, HBV, or HCV.
Severe uncontrolled cardiac or cerebrovascular condition within the previous 6 months

The Estimated Number of Participants

  • Taiwan

    42 participants

  • Global

    714 participants

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