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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)

Short Title: C5851005


Enrollment Status: Not yet recruiting

NCT #: NCT07144280

Specialty Area: Oncology

Condition Studied: Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with PD-L1 expression

Age Groups: Adult; Older Adult

Phase: III


Study Information

Summary / Purpose

To study a new treatment approach for people with locally advanced or metastatic non-small cell lung cancer whose disease has continued to grow after prior therapy. This study is comparing an investigational targeted therapy given alone or in combination with an immunotherapy medication to a standard treatment approach to see how well each works and how safe they are. The goal of the study is to learn whether the investigational approach may help control the cancer more effectively or with a different side effect profile.

Study Type: Interventional
Accepts Healthy Volunteers: No

Who Can Participate

Eligibility Criteria:
  • Adults 18+ years of age
  • Diagnosed with advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has a PD-L1 expression of at least 1% and has progressed after prior standard treatments, including platinum-based chemotherapy and immunotherapy.
  • Certain genetic mutations (such as EGFR or ALK) may also be eligible if they have already received the appropriate targeted therapies.
  • No uncontrolled brain metastases, a recent history of other cancers (with some exceptions)
  • No prior treatment with docetaxel or similar investigational agents, or serious uncontrolled medical conditions.

What's Involved

Participation in the study will include:
  • Being randomly assigned to receive either the investigational drug PF-08046054 (SGN-PDL1V) or the chemotherapy drug Docetaxel given by intravenous (IV) infusion in repeating treatment cycles.
  • Attending regular clinic visits for safety monitoring, physical exams, blood tests, and imaging scans to evaluate how the cancer responds to treatment and to monitor for side effects.
  • Attending follow-up visits after treatment ends.

Principal Investigator

Additional Information

Location: Renown Health, Office of Clinical Research
Address:

1500 E 2nd St. Reno, NV 89502

General Research: 775-982-3646
Oncology Research: 775-982-5050
Email: Renown-CRD@renown.org

Disclaimer: This listing gives you general information about the study and isn't part of the official consent process. If you decide to learn more, the research team will talk with you and check if you meet any additional requirements to join the study.

ER Wait Times

How are wait times calculated?

Our estimated ER wait times reflect the average time from check-in to being seen by a medical professional during triage, where patients are prioritized based on the severity of their condition.

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