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RecruitingPhase 3

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)

PADL1NK-005: A Randomized, Phase 3, Open-Label Study to Evaluate 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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years
  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants in the PF-08046054 treatment group will receive an IV infusion (injected directly into the veins) twice during each 21-day cycle."
  • "Participants in the docetaxel treatment group will receive an IV infusion once during each 21-day cycle."
  • "Study participation may be up to 5 years if the participant's NSCLC is responding to treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares PF-08046054/SGN-PDL1V with docetaxel, a standard cancer drug. It is for adults with non-small cell lung cancer that has spread or cannot be treated with surgery or radiation meant to cure it. The cancer must have a protein called PD-L1 and have gotten worse after earlier treatment, or the person could not tolerate their latest treatment.

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 greater than or equal to 1% and had cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted treatment regimen(s) for participants with known actionable genomic alterations (AGAs). Participants in this study must have cancer that has spread through their body or can't be removed with surgery or treated with definitive radiation. Participants will randomly (like a flip of the coin) be assigned to either the PF-08046054 treatment group or the docetaxel treatment group. Participants in the PF-08046054 treatment group will receive an IV infusion (injected directly into the veins) twice during each 21-day cycle. Participants in the docetaxel treatment group will receive an IV infusion once during each 21-day cycle. Study participation may be up to 5 years if the participant's NSCLC is responding to treatment. The study team will see how each participant is doing with the study treatment during regular visits at the clinic.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have non-small cell lung cancer confirmed by a tissue or cell test. It must be stage IIIB or IIIC that cannot be removed or treated with chemotherapy plus radiation meant to cure it, or stage IV cancer that has spread.
  • Have PD-L1 on at least 1% of tumor cells, shown by a required lab test.
  • Provide a stored tumor sample or a new tumor sample, if it is safe to collect one.
  • Your cancer got worse during your latest treatment, came back afterward, or you could not tolerate that treatment.
  • If you have no known gene changes that can be targeted with drugs: have had platinum-based chemotherapy for cancer that spread or came back, plus PD-1 or PD-L1 immune treatment unless you could not safely receive it. Another allowed path is cancer worsening within 6 months of earlier platinum chemotherapy, with immune treatment given at any time.
  • If you have gene changes that can be targeted with drugs: have had at least one matching treatment, if locally available, and your doctor thinks more targeted treatment is not best for you.
  • If you have these gene changes: also have had platinum-based chemotherapy for cancer that spread or came back, or cancer worsened within 6 months of earlier platinum chemotherapy. Prior PD-1 or PD-L1 immune treatment is optional.

Who can't join

  • Cancer with neuroendocrine cells, which have features of nerve and hormone-making cells.
  • Another cancer within the past 3 years, or cancer left over from an earlier diagnosis. Some cancers with a very low risk of spreading or causing death are allowed.
  • Cancer spots in the brain or spinal cord that have not been fully treated with surgery or radiation.
  • Treated brain cancer spots that have worsened, or were treated less than 28 days before group assignment. If steroids are needed, the dose must be stable at no more than 10 mg of prednisone daily, or an equal dose of another steroid, for more than 14 days.
  • Any history of cancer spreading to the lining around the brain or spinal cord.
  • Recent anti-PD-L1 treatment within the study's required waiting period, which depends on how long the drug stays in the body.
  • Past treatment with docetaxel or a drug containing MMAE, a cancer-killing substance.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria * 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 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. * 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 * 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: * 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. 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 relevant AGA-targeted therapy if locally available 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-(L)1 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. * 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: * The participant is on a stable dose of ≤10 mg/day of prednisone or equivalent for at least \>14 days prior to randomization (if requiring steroid treatment). * No clinical or radiographic progression in the CNS following CNS-directed definitive radiotherapy and/or surgery. * Time since CNS-directed treatment is ≥28 days prior to randomization. * 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 MMAE-containing agent or prior docetaxel. There are additional inclusion and exclusion criteria. The study center will determine if criteria for participations are met.

Study sites (241)

AK

AL

AR

CA

CO

DE

FL

GA

IL

KY

LA

MA

MD

MN

MO

MS

MT

NE

NJ

NM

NV

NY

OH

OR

PA

TN

TX

VA

WA