Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

A study of PF-08634404 and a drug combination in adults with advanced or metastatic non-small cell lung cancer

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Featured sites

Sites that work closely with us on this trial

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is designed to compare the effectiveness and safety of two different treatment approaches for adults with Non-Small Cell Lung Cancer that is either Locally Advanced or Metastatic. This means the cancer is either growing into nearby tissues or has spread to other parts of the body. The purpose of the study is to determine if a new medicine, PF-08634404, used along with Chemotherapy, works better than a current treatment combining Pembrolizumab with chemotherapy.

The treatments involve medications administered through an Intravenous line, which is a method of delivering medicine directly into a vein. One group receives the study drug PF-08634404 along with a combination of chemotherapy drugs, which may include Paclitaxel, Carboplatin, or Pemetrexed. Another group receives Pembrolizumab combined with these chemotherapy drugs. Some participants may also receive Paclitaxel Albumin-Bound or a Placebo involving Sodium Chloride. During the study, participants will be monitored to see how they respond to the medicines and to track their Overall Survival and Progression-Free Survival, which refers to the length of time during and after treatment that a person lives with the disease without it getting worse.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study participation and group assignment

    After joining the study, one of two different treatment paths will be assigned through a process called randomization, which means the assignment is made by chance.

    The two paths are experimental, receiving a combination of pf-08634404 and chemotherapy, or control, receiving pembrolizumab and chemotherapy.

  2. Step 2

    Administration of treatments

    In the experimental arm, the treatment consists of pf-08634404, which is given through an intravenous infusion (delivered directly into a vein), combined with chemotherapy.

    The chemotherapy used in this group includes carboplatin, pemetrexed, and either paclitaxel or paclitaxel albumin-bound, all administered via intravenous methods.

    In the control arm, the treatment consists of pembrolizumab, which is given through an intravenous infusion, combined with chemotherapy.

    The chemotherapy used in this group includes carboplatin and pemetrexed, administered through intravenous methods.

  3. Step 3

    Monitoring and evaluation

    Throughout the study, overall survival, which is the length of time from the start of treatment that patients remain alive, is monitored.

    The progression-free survival, or the time during and after treatment that the disease does not get worse, is assessed by blinded independent central review (an evaluation by doctors who do not know which treatment was received).

    adverse events, which are any unexpected medical problems or side effects, are recorded by type, frequency, and severity.

    laboratory tests are used to monitor any changes in blood or other bodily fluids.

    The response rate, which measures how much the cancer shrinks, is monitored.

    The duration of response, which is how long the cancer stays shrunk, is tracked.

    Levels of pf-08634404 in the body are measured before and after doses, along with the presence of any anti-drug antibodies (proteins the body may create in response to the medicine).

    Changes in quality of life, including physical function and symptoms such as shortness of breath, cough, and chest pain, are evaluated.

Who can join the trial?

8 criteria

  • You must be 18 years of age or older.
  • You must have a confirmed diagnosis of locally advanced (cancer that has spread to nearby parts of the body) or metastatic (cancer that has spread to distant parts of the body) non-small cell lung cancer.
  • The cancer must be squamous or non-squamous in type and cannot be treated by complete surgical resection (the complete removal of the tumor through surgery) or curative chemoradiation (a combination of chemotherapy and radiation therapy intended to cure the disease).
  • You must have tumor tissue available, such as a paraffin block (a small sample of tissue preserved in wax) or slides from a biopsy (a procedure to remove a small piece of tissue for testing).
  • Your PD-L1 status must be known, which refers to a specific protein level on your cancer cells that helps doctors determine if certain treatments will work.
  • You must have measurable disease, meaning the tumors can be clearly seen and measured on scans according to standard medical rules called RECIST v1.1.
  • Your ECOG PS score must be 0 or 1, which is a scale used to measure how well you can perform daily activities and your overall physical strength during the illness.
  • Your expected survival must be 12 weeks or longer.

Who cannot join the trial?

20 criteria

  • You cannot participate if you have certain genetic mutations (known as AGAs) such as EGFR, ALK, ROS1, NTRK, BRAF, RET, or MET, because there are already specific approved treatments available for these.
  • You are ineligible if you had major surgery within the last 4 weeks or minor surgery within the last 3 days.
  • You cannot join if you have a history of severe bleeding problems or coagulation dysfunction, which means your blood does not clot normally.
  • You are excluded if you had esophageal varices (swollen veins in the food pipe), severe ulcers, unhealed wounds, gastrointestinal perforation (a hole in the digestive tract), abdominal fistula (an abnormal connection between organs), gastrointestinal obstruction (a blockage in the intestines), abdominal abscess (a collection of pus), or stomach bleeding within the last 6 months.
  • You cannot participate if you have an active infection, including HIV, HBV (Hepatitis B), or HCV (Hepatitis C).
  • You are ineligible if you have a history of immunodeficiency, which means your immune system does not work correctly to fight infections.
  • You cannot join if you have any medical or mental health conditions, including suicidal thoughts or behavior within the last 5 years, or any health issues that make participating in the study unsafe.
  • You are excluded if you have had previous cancer treatments, such as immunotherapy, radiotherapy (radiation treatment) to the lungs within the last 6 months, or certain types of targeted therapies.
  • You cannot participate if you previously had immune-related adverse events, which are side effects caused by the immune system attacking healthy cells, that required you to stop treatment or take immunosuppressive therapy (medicine to dampen the immune system).
  • You are ineligible if you have taken blood thinners (anticoagulants or antiplatelet therapy) very recently, or if you have received a live vaccine within the last 4 weeks.
  • You cannot join if you are currently taking high-dose steroids or other prohibited medications.
  • You are excluded if you are breastfeeding, or if you are a person capable of becoming pregnant or a male who is unwilling to use contraception (birth control).
  • You cannot participate if you have active lesions in the Central Nervous System (CNS), which refers to the brain or spinal cord, though some small, inactive brain metastases (cancer that spread to the brain) may be allowed.
  • You are ineligible if you have a high risk of hemorrhage (severe bleeding) or a fistula (an abnormal opening in the body).
  • You cannot join if you have had another type of cancer within the last 3 years or if there is any sign of a previous cancer still present.
  • You are excluded if you still have unresolved side effects from previous cancer treatments that have not improved to a mild level (Grade 0 or 1).
  • You cannot participate if you have a history of severe allergies to the study medicine or to antibodies (proteins used in certain treatments).
  • You are ineligible if you have had an organ transplant or a stem cell transplant.
  • You cannot join if you have certain lung conditions, such as ILD or pneumonitis (inflammation of the lung tissue) or if your lung function test (DLCO) is too low.
  • You are excluded if you have had uncontrolled health problems in the last 6 months, such as heart disease, stroke, high blood pressure, diabetes, or blood clots.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Paclitaxel

    is a type of chemotherapy medicine used to treat cancer by stopping cancer cells from growing and dividing.

  • PF-08634404

    is an experimental treatment being studied to see if it helps fight cancer when combined with other medicines.

  • Paclitaxel albumin-bound

    is a specialized form of chemotherapy designed to deliver the medicine more effectively to cancer cells.

  • Pembrolizumab

    is an immunotherapy medicine that helps the body's own immune system recognize and attack cancer cells.

  • Carboplatin

    is a chemotherapy drug used to slow or stop the growth of cancer cells.

  • Pemetrexed

    is a chemotherapy medication used to treat certain types of cancer by interfering with the way cancer cells grow.

What is already known about the treatment

  • Paclitaxel

    This medication is an established chemotherapy drug administered through an intravenous injection into a vein. It is widely used to treat various types of cancer, including lung cancer, by working at a molecular level to stop cancer cells from dividing and growing. As a taxane-class anti-cancer agent, it freezes the internal structure of cells so they cannot multiply.

  • PF-08634404

    This is an experimental drug currently being studied in clinical trials, provided as a concentrated solution for infusion through an intravenous line. It is being investigated for its ability to treat advanced lung cancer by targeting specific proteins involved in cancer cell survival. This substance belongs to a class of targeted therapy agents designed to interfere with the growth signals of tumor cells.

  • Sodium chloride

    This is a common salt solution used as a placebo in this study and is administered through an intravenous drip. In clinical trials, it serves as a neutral substance to ensure that results are due to the active medications rather than patient expectations. It is a basic saline solution used widely in medical settings for hydration and as a carrier for other drugs.

  • Paclitaxel albumin-bound

    This is a specialized form of chemotherapy administered via intravenous infusion that uses a protein called albumin to carry the medicine through the body. It is an approved treatment for certain cancers, designed to deliver the drug more effectively to tumor sites. By attaching the medicine to a natural protein, it helps the drug reach cancer cells more efficiently while potentially reducing some side effects.

  • Pembrolizumab

    This is a well-known immunotherapy medication given through an intravenous infusion to treat many types of cancer, including lung cancer. It works by blocking a specific protein on immune cells that cancer uses to hide from the body's natural defenses. This drug is classified as an immune checkpoint inhibitor, which helps the patient's own immune system recognize and attack the cancer.

  • Carboplatin

    This is a standard chemotherapy drug that is administered through an intravenous injection. It is frequently used in combination treatments for various cancers, including lung cancer, to damage the DNA of rapidly dividing cells. It belongs to a class of medicines called platinum-based antineoplastic agents, which stop cancer cells from replicating.

Investigated diseases

Locally advanced or metastatic non-small cell lung cancer - This is a type of cancer that starts in the cells of the lung and is not composed of small, round cells. Locally advanced means the cancer has grown into nearby structures or tissues near the lungs. Metastatic means the cancer cells have spread from the original site in the lung to other parts of the body. As the disease progresses, these cells can form new tumors in distant organs. The condition typically involves the uncontrolled growth of abnormal cells within the lung tissue.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523461-17-01Protocol codeC6461001Estimated enrolment1 410 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).