Comparing PF-08046054 with Docetaxel monotherapy for non-small cell carcinoma

Inclusion

• +Participants with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations) must fulfill the following conditions:
• +Participants with a history of leptomeningeal metastasis are excluded.
• +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 ControlControl groupThe group a new treatment is measured against.Read more → (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 biomarkerBiomarkerSomething measurable in the body used as a signal of what is happening.Read more → 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:
• +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
• +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.
• +The participant is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least \>14 days prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (if requiring steroid treatment).
• +Time since CNS-directed treatment is ≥28 days prior to randomization.
• +Prior treatment with an anti-PD-L1 agent (where indicated per protocolProtocolThe detailed plan a study must follow.Read more →) within 5 half-lives.
• +Previous receipt of an MMAE-containing agent or prior docetaxel.
• +There are additional inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteria. The study center will determine if criteria for participations are met.
• +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.
• +Must have received at least 1 relevant AGA-targeted therapy if locally available and, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, 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).
• +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:
• +No clinical or radiographic progression in the CNS following CNS-directed definitive radiotherapy and/or surgery.