PF-08634404 + Chemotherapy for Non-Small Cell Lung Cancer
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PF-08634404 alone or in combination with chemotherapy, depending on their assigned part (A, B, or C)
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participants with locally advanced, unresectable NSCLC without AGAs who did not have progressive disease per RECIST 1.1 after definitive, platinum-based concurrent chemoradiotherapy (cCRT) and are candidates for consolidation treatment will receive PF-08634404 IV.
Participants with early-stage or locally advanced, resectable NSCLC without AGAs who did not achieve pCR after standard-of-care (SOC) neoadjuvant chemo-immunotherapy and are candidates for adjuvant treatment will receive PF-08634404 IV.
Participants with treatment naïve early-stage or locally advanced, resectable NSCLC without Actionable Genomic Alterations (AGAs) who are candidates for neoadjuvant treatment will receive intravenous (IV) PF-08634404 in combination with chemotherapy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
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.
pfizerclinicaltrials.com
pfizerclinicaltrials.com/find-a-trial/nct07222566-advanced-non-small-cell-lung-cancer-trialClinical 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
P1 data • P2 data • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Melanoma • Non Small Cell Lung Cancer · Print · Email · More sharing.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.