PF-08046054 vs Docetaxel for Lung Cancer

Recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Must not be taking: Corticosteroids, Anti-PD-L1, Docetaxel, MMAE

Disqualifiers: Other malignancy, Active CNS lesions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 5 years

680 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if the new drug, PF-08046054, is more effective than the standard treatment, docetaxel, for individuals with non-small cell lung cancer (NSCLC). It targets participants whose cancer has metastasized or cannot be treated with surgery or radiation, and who have previously undergone treatments such as chemotherapy and drugs targeting genetic changes in their cancer. The trial seeks individuals with NSCLC who have not responded to other treatments and have PD-L1 expression of 1% or more in their tumors. Participants will be randomly assigned to receive either PF-08046054 or docetaxel, both administered as IV infusions. As a Phase 3 trial, this study serves as the final step before potential FDA approval, offering participants the opportunity to contribute to the development of a promising new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team to understand any specific requirements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that PF-08046054, a treatment for non-small cell lung cancer (NSCLC), is generally well tolerated. In earlier studies, patients with advanced NSCLC who took PF-08046054 experienced manageable side effects that were not severe.

The treatment remains under investigation, but early results are promising, showing potential in fighting cancer cells. Like any new treatment, side effects may occur, but current data suggests they should be manageable.

For those considering joining a trial, this information indicates that PF-08046054 could be a safe option. Always consult a doctor to determine the best course of action for your health situation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Unlike the standard treatment for lung cancer, which often includes chemotherapy drugs like Docetaxel, PF-08046054 is unique because it introduces a novel mechanism of action. Most chemotherapy drugs work by disrupting cell division, but PF-08046054 targets specific pathways involved in cancer cell growth, potentially offering a more precise attack on cancer cells. Researchers are excited about PF-08046054 because it might result in fewer side effects and improved effectiveness compared to traditional chemotherapy options. This targeted approach could lead to better outcomes for patients with lung cancer.

What evidence suggests that this trial's treatments could be effective for non-small cell lung cancer?

This trial will compare PF-08046054 with Docetaxel for treating non-small cell lung cancer (NSCLC). Research has shown that PF-08046054, which participants in this trial may receive, could be a promising treatment for NSCLC. Early results suggest this drug can help shrink tumors in patients whose cancer has spread or returned after other treatments. These findings also indicate that the side effects of PF-08046054 are manageable. Docetaxel, another treatment option in this trial, is already known to be effective for NSCLC. However, PF-08046054 might offer a new option, especially for patients who have already tried other therapies. ^{1 2 4 6 7}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Adults with previously-treated PD-L1 positive NSCLC, who have tried platinum-based chemo and PD-1/PD-L1 inhibitors. They must have cancer that's spread or can't be surgically removed/radiated. Not for those with neuroendocrine components in their cancer or less than 1% PD-L1 expression.

Inclusion Criteria

My cancer worsened within 6 months after platinum chemotherapy and I've had PD-1/PD-L1 therapy.

My lung cancer is at an advanced stage and cannot be removed by surgery.

My tumor shows PD-L1 expression on more than 1% of cells.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either PF-08046054 or docetaxel via IV infusion. PF-08046054 is administered twice during each 21-day cycle, while docetaxel is administered once per cycle.

Up to 5 years

Regular visits at the clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Docetaxel
• PF-08046054

Trial Overview The trial is testing PF-08046054 against standard docetaxel to see which is better for advanced NSCLC after other treatments failed. Participants are randomly assigned to one of the two drugs, given via IV every few weeks, with possible treatment up to five years.

How Is the Trial Designed?

Group I: PF-08046054 monotherapy Experimental Treatment 1 Intervention

PF-08046054 monotherapy

Group II: Docetaxel monotherapy Active Control 1 Intervention

Docetaxel monotherapy

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.8611

Interim results of PDL1V (PF-08046054), a vedotin-based ... Here we present the safety profile and preliminary efficacy in patients with metastatic, relapsed/refractory non-small cell lung cancer (NSCLC) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07144280

NCT07144280 | A Study to Learn About the ... The purpose of this study is to understand if PF-08046054 alone works well compared to standard-of-care docetaxel alone in participants with ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05208762

NCT05208762 | A Study of PF-08046054/SGN-PDL1V in ... This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.6033

Initial safety and efficacy of PDL1V (PF-08046054), a ... A secondary objective is antitumor activity. Results: As of December 20, 2024, 14 patients were dosed; median age was 61 years (range 36–76).

5. pfizerclinicaltrials.com pfizerclinicaltrials.com/find-a-trial/nct07144280-non-small-cell-carcinoma-trial

Clinical Trial for Non-small Cell Carcinoma ... 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 ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02193-8/fulltext

607O Interim results of a phase I study of SGN-PDL1V (PF- ... Single agent SGN-PDL1V was generally well tolerated with a manageable safety profile. Encouraging preliminary antitumor activity was observed. Enrollment in the ...

7. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/pf-08046054-pfizer-non-small-cell-lung-cancer-likelihood-of-approval/

PF-08046054 by Pfizer for Non-Small Cell Lung Cancer PF-08046054 is under clinical development by Pfizer and currently in Phase I for Non-Small Cell Lung Cancer.