*Non-small Cell Carcinoma *Non-Small Cell Lung Cancer Metastatic *Non-Small Cell Lung Carcinoma
Conditions
Interventions
*Drug: PF-08046054
-Antibody Drug Conjugate
Participants will receive PF-08046054, administered as an IV infusion.
-Other Names:
#SGN-PDL1V
*Drug: Docetaxel monotherapy
-Participants will receive Doce
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1.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. 2.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. 3.Participants who have NSCLC with known AGAs are permitted (eg, EGFR mutations, ALK translocations). 4.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. 5.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
Exclusion criteria: Exclusion Criteria 1.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. 2.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 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. 3.Participants with a history of leptomeningeal metastasis are excluded. 4.Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within 5 half-lives. 5.Previous receipt of an MMAE-containing agent or prior docetaxel. There are additional inclusion and exclusion criteria. The study center will determine if criteria for participations are met.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Overall Survival [Time Frame: Approximately 5 years] -Overall survival defined as the time from the date of randomization to the date of death due to any cause. *Progression Free Survival (PFS) assessed by blinded independent central review (BICR) [Time Frame: Approximately 5 years] -Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by BICR per RECIST v1.1, or death due to any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Objective Response Rate as assessed by BICR [Time Frame: Approximately 5 years] -The proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1. *Progression Free Survival as assessed by Investigator [Time Frame: Approximately 5 years] -Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST v1.1, or death due to any cause, whichever occurs first. *Objective Response Rate (ORR) as assessed by Investigator [Time Frame: Approximately 5 years] -The proportion of participants who have a confirmed CR or PR, as best overall response assessed by investigator as per RECIST 1.1. *Duration of Response as assessed by BICR [Time Frame: Approximately 5 years] -The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by BICR assessment per RECIST v1.1, or death due to any cause, whichever occurs first. *Duration of Response as assessed by Investigator [Time Frame: Approximately 5 years] -The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first. *Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation [Time Frame: Through 90 days after the last study intervention; Approximately 5 years] -An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. *Mean scores and Change from baseline in the global health status/quality of life (QoL) score on the European Organisation for Research and Treatment of Cancer Quality of L | — |
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed