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 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.

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