Status:
RECRUITING
A Study to Learn About the Study Medicine Called 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)
Lead Sponsor:
Pfizer
Conditions:
Non-small Cell Carcinoma
Non-Small Cell Lung Cancer Metastatic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to understand if PF-08046054 alone works well compared to standard-of-care docetaxel alone in participants with non-small cell lung cancer (NSCLC) with PD-L1 expression gr...
Eligibility Criteria
Inclusion
- 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:
- 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 a PD-L1 or PD-1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy), unless contraindicated.
- 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-L1 or PD-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 approved AGA-targeted therapy 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-1 or PD-L1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
- 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.
- There are additional inclusion and exclusion criteria. The study center will determine if criteria for participations are met.
Exclusion
Key Trial Info
Start Date :
September 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 10 2032
Estimated Enrollment :
680 Patients enrolled
Trial Details
Trial ID
NCT07144280
Start Date
September 29 2025
End Date
March 10 2032
Last Update
December 15 2025
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