PF-08634404 + Chemotherapy for Non-Small Cell Lung Cancer

Recruiting at 16 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Must not be taking: Anticoagulants, Antiplatelets, Corticosteroids, others

Disqualifiers: Genomic alterations, 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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 6

Duration: 48 weeks

1410 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new medicine, PF-08634404, used with chemotherapy, is more effective than the current standard treatment for non-small cell lung cancer (NSCLC). NSCLC is a type of lung cancer that may have spread to nearby tissues or other parts of the body. The study involves two groups: one receiving PF-08634404 (an experimental treatment) with chemotherapy and another receiving an approved medicine, pembrolizumab, with chemotherapy. Individuals with NSCLC that has advanced locally or spread, and who have not received treatment for advanced disease, might be suitable for this trial. Participants will receive treatments through IV infusions and will undergo regular health checks. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but certain medications are prohibited close to the start of the trial, such as anticoagulants, antiplatelet therapy, and high-dose corticosteroids. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

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

Research shows that PF-08634404, when used alone to treat non-small cell lung cancer (NSCLC), has produced promising results. It works effectively and has a manageable safety profile, meaning side effects are not too severe.

Pembrolizumab, a well-known treatment for NSCLC, has been used for several years. Studies have shown that it extends patients' lives, and its safety is well-established. Patients generally tolerate pembrolizumab well, although some side effects can occur.

In this study, both treatments are combined with chemotherapy, which may increase side effects. However, existing data suggests that these treatments are generally safe, and side effects can be managed. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for non-small cell lung cancer?

Researchers are excited about PF-08634404 because it represents a new approach in treating non-small cell lung cancer. Unlike current treatments, which often include pembrolizumab, PF-08634404 is an investigational drug that may offer a different mechanism of action or enhanced effectiveness when combined with chemotherapy. This treatment is being explored in combination with two different chemotherapy regimens, which could provide flexibility and potentially better outcomes for patients. The innovative use of PF-08634404 could lead to more personalized and effective treatment strategies for those battling this type of lung cancer.

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

Research has shown that PF-08634404, a new medicine, holds promise for treating non-small cell lung cancer (NSCLC). Early studies suggest it works well with chemotherapy, offering good effectiveness and manageable safety for patients. In this trial, some participants will receive PF-08634404 combined with chemotherapy regimen 1 or 2. Pembrolizumab, on the other hand, has already proven very effective for NSCLC. Participants in other arms of this trial will receive pembrolizumab combined with chemotherapy regimen 1 or 2. Research indicates that when pembrolizumab is used with chemotherapy, it improves long-term outcomes for patients with advanced NSCLC. Overall, this trial examines whether PF-08634404 with chemotherapy can surpass the current standard treatment of pembrolizumab with chemotherapy. ^{1 2 3 4 6}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

Adults with advanced non-small cell lung cancer (NSCLC) that can't be fully removed by surgery or cured with chemoradiotherapy. Participants must be over 18, have a certain level of physical fitness (ECOG score of 0 or 1), and not have specific genetic changes in their cancer. They need to have measurable disease and available tumor tissue for testing.

Inclusion Criteria

My doctor expects me to live for at least 12 more weeks.

I have tumor tissue samples available for testing.

My cancer's PD-L1 status is known from tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PF-08634404 or Pembrolizumab in combination with chemotherapy, followed by maintenance therapy

48 weeks

Regular visits for treatment and health checks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 39 months

Tests to monitor cancer response every 6 weeks during the first 48 weeks, then every 12 weeks thereafter

What Are the Treatments Tested in This Trial?

Interventions

• Chemotherapy Regimen 1
• Chemotherapy Regimen 2
• Pembrolizumab
• PF-08634404

Trial Overview

The trial is comparing the effectiveness of a new drug called PF-08634404 combined with chemotherapy against the standard treatment pembrolizumab plus chemotherapy in treating NSCLC. Patients are randomly assigned to either the experimental group receiving PF-08634404 or the control group receiving pembrolizumab, both alongside tumor-specific chemo.

How Is the Trial Designed?

Group I: Arm C Experimental Treatment 2 Interventions

Participants will receive PF-08634404 combined with chemotherapy regimen 2, followed by maintenance therapy with PF-08634404 and chemotherapy.

Group II: Arm A Experimental Treatment 2 Interventions

Participants will receive PF-08634404 combined with chemotherapy regimen 1, followed by maintenance therapy with PF-08634404.

Group III: Arm B Active Control 2 Interventions

Participants will receive pembrolizumab combined with chemotherapy regimen 1, followed by maintenance therapy with pembrolizumab.

Group IV: Arm D Active Control 2 Interventions

Participants will receive pembrolizumab combined with chemotherapy regimen 2, followed by maintenance therapy with pembrolizumab and chemotherapy.

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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07222566

NCT07222566 | A Study to Learn About the ...

This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment ...

2.

pfizerclinicaltrials.com

pfizerclinicaltrials.com/find-a-trial/nct07227298-advancedmetastatic-non-small-cell-lung-cancer-trial

Advanced/Metastatic Non-Small Cell Lung Cancer ...

This study is being done to learn more about a new medicine called PF-08634404 and how it works when used with other cancer medicines in people who have ...

3.

jitc.bmj.com

jitc.bmj.com/content/13/Suppl_3/A1568

1328 SSGJ-707, a PD-1/VEGF bispecific antibody ...

Results from a phase 2 study demonstrated promising efficacy and manageable safety as monotherapy in first-line NSCLC with tumor proportion ...

4.

s206.q4cdn.com

s206.q4cdn.com/795948973/files/doc_events/2025/Nov/10/PfizerPflash_-4404-SITC-IR-Event-2025_FINAL.pdf

Pfizer Pflash: A Spotlight on the PF'4404 (SSGJ-707 / PF ...

Epidemiology data are rounded, and sourced from US CancerMPact Patient Metrics, Oracle (2025), includes total incident and newly recurrent ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07226999

NCT07226999 | A Study to Learn About the ...

This study is being done to learn more about a new medicine called PF-08634404 and how well it works when given with chemotherapy to adults with ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07227298

NCT07227298 | A Study to Learn About the ...

This study is being done to learn more about a new medicine called PF-08634404 and how it works when used with other cancer medicines in people who have ...