120 Participants NeededMy employer runs this trial

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

Recruiting at 26 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Pfizer
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore a new medicine called PF-08634404, an experimental treatment for non-small cell lung cancer (NSCLC). Researchers seek to determine its effectiveness alone or with chemotherapy in individuals with early-stage or locally advanced NSCLC. The trial seeks participants in good physical condition with NSCLC that is either early-stage or locally advanced and may or may not be surgically removable. Participants will be grouped based on their specific type of NSCLC and previous treatments to test different treatment combinations. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss your specific situation with the study team or your doctor.

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

Previous studies have shown that PF-08634404 has a manageable safety profile, meaning that while some side effects exist, they are generally tolerable. For instance, an earlier study found that when used alone in patients with advanced non-small cell lung cancer, PF-08634404 was effective, with manageable side effects such as fatigue and nausea, common in many cancer treatments.

PF-08634404 is a bispecific antibody that targets proteins involved in cancer cell growth. This type of treatment has been tested in other conditions, suggesting relative safety.

However, PF-08634404 remains investigational and is not yet approved for general use. The current study is part of ongoing research to confirm its safety and effectiveness. A medical team will closely monitor trial participants to manage any side effects that may occur.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-08634404 for non-small cell lung cancer (NSCLC) because it offers a unique approach compared to the standard options like surgery, chemotherapy, and immunotherapy. Unlike these treatments, PF-08634404 can be used as a monotherapy in different stages of NSCLC, either alone or in combination with chemotherapy, which might enhance its effectiveness. It specifically targets cancer cells without Actionable Genomic Alterations (AGAs), potentially offering a tailored treatment for patients who don't respond fully to existing therapies. This targeted approach could lead to better outcomes, making it a promising option in the fight against NSCLC.

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

Research has shown that PF-08634404, one of the treatments in this trial, holds promise for treating non-small cell lung cancer (NSCLC) when used alone. Studies have found that patients with a certain level of PD-L1, a protein on cancer cells, responded well to this treatment. In this trial, some participants will receive PF-08634404 as monotherapy, either as adjuvant or consolidation treatment. Others will receive PF-08634404 combined with chemotherapy as neoadjuvant treatment. When combined with chemotherapy, PF-08634404 has sometimes outperformed standard treatments. This combination has proven to be safe with manageable side effects. This experimental treatment targets PD-1 and VEGF, proteins that aid cancer growth, suggesting it could effectively slow or stop cancer progression.13467

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults (18+) with early-stage or locally advanced non-small cell lung cancer. Participants must be in good health, have healthy organs, and no known DNA changes that affect treatment. The study includes those who may have surgery, need more therapy after surgery, or can't have surgery but finished chemo-radiation.

Inclusion Criteria

My organs are working well enough for treatment.
My PD-L1 test results are available.
I am fully active or restricted in physically strenuous activity only.
See 5 more

Exclusion Criteria

My non-squamous lung cancer tested negative for EGFR and ALK mutations.
I have a high risk of serious bleeding or abnormal connections between organs.
I have an active or ongoing infection like HIV, hepatitis B, or hepatitis C.
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PF-08634404 alone or in combination with chemotherapy, depending on their assigned part (A, B, or C)

Up to 6 months
Multiple visits at clinical study sites

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • PF-08634404

Trial Overview

The study tests a new drug called PF-08634404 alone or combined with chemotherapy in three groups: before surgery, after incomplete response to prior treatment and surgery, or as extra therapy after chemo-radiation if the tumor can’t be removed by surgery.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Part C: PF-08634404 Monotherapy Consolidation after Definitive ChemoradiotherapyExperimental Treatment1 Intervention
Group II: Part B: Adjuvant PF-08634404 MonotherapyExperimental Treatment1 Intervention
Group III: Part A: Neoadjuvant PF-08634404 + ChemotherapyExperimental Treatment3 Interventions

Find a Clinic Near You

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 profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Citations

Clinical Trial for Advanced Non-Small Cell Lung Cancer ...

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 ( ...

NCT07476287 | Symbiotic-Lung-14: A Study to Learn ...

The study team wants to understand how well PF-08634404 works when given alone or with chemotherapy . Chemotherapy is a type of cancer treatment that uses ...

PD-1 x VEGF Bispecific Antibody

PF-08634404 is an investigational compound. Its safety and efficacy have not been established. A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN ...

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 ...

440TiP A phase II/III trial of a PD-1/VEGF bispecific ...

Phase II studies have shown promising efficacy and manageable safety with PF-08634404 as a monotherapy and with chemotherapy in first-line non-small cell lung ...

Symbiotic-Lung-10: A Study to Learn About PF-08634404 ...

The study is for adults with early stage or locally advanced non-small cell lung cancer (NSCLC) that may or may not be removable with surgery. The study is ...

PF-08634404 / 3SBio, Pfizer

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