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Phase 2 Study of Safety and Efficacy of PF-08634404 Alone or with Drug Combination in Adults with Early-Stage or Locally Advanced Non-Small Cell Lung Cancer

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What is this trial about?

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

The study looks at adults with early‑stage resectable or locally advanced unresectable Non-Small Cell Lung Cancer, a common type of lung cancer. “Early‑stage resectable” means the tumor is still small enough that doctors think it can be removed by surgery, while “locally advanced unresectable” means the tumor has grown too much to be taken out. The medication being tested is a new drug called PF-08634404, given alone or together with standard chemotherapy drugs paclitaxel, carboplatin, and pemetrexed, which are delivered through a vein.

The purpose of the study is to learn how safe the new drug is and whether it can improve outcomes when used before surgery (called neoadjuvant therapy), after surgery (called adjuvant therapy), or as extra treatment after the main therapy (called consolidation therapy). In the first part, participants receive the new drug combined with the chemotherapy drugs before any surgery to see if the tumor shrinks enough to allow an operation and to monitor side effects. In the second part, the new drug is given by itself after surgery to check safety and tolerance, and in the third part it is given after the main treatment to see if it can be safely added. Participants receive the medication by infusion, have regular check‑ups, may undergo surgery if it becomes possible, and are followed over time to watch for any health problems.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Neoadjuvant therapy (part a)

    You will receive pf-08634404 together with a platinum doublet chemotherapy regimen that includes paclitaxel, carboplatin and pemetrexed. all drugs are given by intravenous infusion according to the study schedule. the specific dose, frequency and length of treatment are defined in the trial protocol and will be administered by the study team.

  2. Step 2

    Surgery assessment and procedure

    After completing neoadjuvant therapy, the feasibility of surgery will be evaluated. if surgery is possible, you will undergo the planned operation to remove the tumor. the timing of surgery follows the completion of the neoadjuvant treatment period.

  3. Step 3

    Adjuvant therapy (part b)

    Following surgery, you will receive pf-08634404 alone as adjuvant therapy. the drug is administered by intravenous infusion according to the study schedule. the exact dose, how often it is given, and the total duration are specified in the trial protocol.

  4. Step 4

    Consolidation therapy (part c)

    After completing adjuvant therapy, you will continue with pf-08634404 monotherapy as consolidation therapy. this treatment is also given by intravenous infusion following the protocol-defined schedule. dosage, frequency and overall treatment length are outlined in the study plan.

Who can join the trial?

13 criteria

  • Age 18 years or older (or at least the legal age to give consent where you live).
  • If you could become pregnant, you must have a negative pregnancy test at screening and again within 72 hours before the first dose; a false‑positive result is allowed if a doctor confirms you are not pregnant.
  • You must have a known PD‑L1 test result (a lab test that measures a protein on cancer cells) for parts B and C of the study.
  • For part C you must have a confirmed diagnosis of stage III non‑small cell lung cancer that cannot be removed by surgery, have received at least 60 Gy of radiation and at least two cycles of platinum‑based chemotherapy, and your cancer must be stable or better according to standard imaging rules (RECIST 1.1). The cancer must be either squamous or non‑squamous type, without small‑cell or large‑cell neuroendocrine features.
  • For part C, only up to 30 % of participants may have a PD‑L1 tumor proportion score (TPS) less than 1 % (meaning very low PD‑L1 expression).
  • Your overall health performance must be rated as 0 or 1 on the ECOG scale (meaning you are fully active or able to do light work).
  • Doctors must expect you to live at least 12 weeks from the start of the study.
  • Your blood, liver, kidney and other organ tests must be within normal limits and you must not have received blood transfusions or growth‑factor medicines (such as G‑CSF, EPO) in the week before testing.
  • You must sign a written informed consent form agreeing to take part.
  • For part A you must be able to provide a recent sample of your tumor tissue (as a paraffin block or slides) if one is available.
  • For part A you must have newly diagnosed, untreated early‑stage or locally advanced stage II‑IIIA/B non‑small cell lung cancer that doctors consider removable by surgery, and you must be a candidate for pre‑surgery (neoadjuvant) treatment followed by complete removal of the tumor.
  • For part A, the cancer must be either squamous or non‑squamous type, without small‑cell elements or large‑cell neuroendocrine carcinoma.
  • For part B you must have had early‑stage or locally advanced stage II‑IIIA/B non‑small cell lung cancer that was completely removed by surgery, be a candidate for post‑surgery (adjuvant) therapy, and you must not have already achieved a pathological complete response (no cancer left) from prior standard treatment.

Who cannot join the trial?

34 criteria

  • Having known changes in the EGFR or ALK genes (genetic alterations that affect tumor behavior) – you must not have these changes.
  • Having had a major operation or serious injury less than 4 weeks before the first dose, or planning a major operation (not related to lung cancer) during the study; also having a small local surgery within 3 days before the first dose.
  • Having fluid buildup around the lungs (pleural effusion), around the heart (pericardial effusion), or in the abdomen (ascites).
  • Having a strong tendency to bleed or clotting problems, such as significant bleeding inside the body, coughing up blood, or frequent nosebleeds within the past month.
  • Having an active infection, which includes:
    • Currently taking medicines for a viral, bacterial, or fungal infection.
    • Known HIV infection that is not well‑controlled (low CD4 count or high viral load).
    • Positive test for hepatitis B surface antigen.
    • Active hepatitis C infection (positive PCR test).
    • Active or suspected tuberculosis infection.
    • Having a history of weakened immune system (immunodeficiency).
    • Being severely allergic to any part of the study drug or to similar antibody medicines.
    • Having any medical or mental health condition that could increase risk, including suicidal thoughts in the past year or suicidal actions in the past five years, or abnormal lab results that make participation unsafe.
    • Any other situation that the doctor believes would raise the risk of the study or make the results hard to understand.
    • Having lesions in the brain or spinal cord, such as cancer spread to these areas or compression of the spinal cord.
    • Having had another type of cancer within the last 3 years, except for very low‑risk cancers (e.g., certain skin cancers, early‑stage prostate cancer, cervical carcinoma in situ, ductal carcinoma in situ, or stage I uterine cancer).
    • Having side effects from previous cancer treatments that have not fully resolved to mild (grade 0‑1) levels, except for hair loss.
    • Having received an organ transplant or a stem‑cell transplant from another person.
    • Having an active autoimmune disease that required strong medicines (such as disease‑modifying drugs, high‑dose steroids, or other immune‑suppressing drugs) in the past 2 years.
    • Having certain lung problems, including:
      • Previous non‑infectious lung inflammation (interstitial lung disease or pneumonitis) that needed steroids or recurred after immunotherapy.
      • Severe asthma or chronic obstructive pulmonary disease (COPD) that needs systemic steroids or oxygen.
      • Recent serious blood clot in the lungs (pulmonary embolism) within the past 3 months.
      • Autoimmune lung diseases with significant involvement (e.g., rheumatoid arthritis‑related lung disease).
      • Having uncontrolled other health problems within the past 6 months, such as:
        • Unstable chest pain (angina) or recent heart attack.
        • Serious heart rhythm problems or major conduction block.
        • Recent heart bypass surgery.
        • Recent stroke, mini‑stroke (TIA), or brain bleed.
        • Severe heart failure (NYHA class III‑IV).
        • Advanced liver disease (decompensated cirrhosis).
        • Nephrotic syndrome (a kidney disorder causing heavy protein loss).
        • Uncontrolled diabetes (HbA1c ≥ 8 % or symptoms despite treatment).
        • Uncontrolled high blood pressure (≥ 160/100 mm Hg) or poor medication adherence.
        • Severe clotting events (grade > 3) in arteries or veins.
        • Hypertensive crisis or brain effects from very high blood pressure.
        • Having a prolonged heart electrical interval on an ECG (> 480 milliseconds, called a QTcF interval), which can increase risk of heart rhythm problems.
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Investigated drugs

Paclitaxel is a chemotherapy medicine given through a vein. It works by stopping cancer cells from growing and dividing. In this study it is used together with other drugs as part of a “platinum doublet” regimen before surgery to shrink lung tumors.

Carboplatin is a platinum‑based chemotherapy given intravenously. It damages the DNA inside cancer cells, which helps stop them from multiplying. In the trial it is one of the drugs in the platinum doublet that is given before surgery.

Pemetrexed is a chemotherapy drug that interferes with the building blocks cancer cells need to make DNA. It is administered by IV and is also part of the platinum doublet chemotherapy used as neoadjuvant treatment in the study.

PF-08634404 is an experimental medicine being tested for lung cancer. It is given by IV infusion and is studied both by itself (as a single‑agent treatment after surgery or as a follow‑up therapy) and together with the platinum doublet chemotherapy. The goal is to see if it can improve safety, how well patients tolerate it, and whether it helps shrink or eliminate tumors.

The combination of PF-08634404 with the platinum doublet chemotherapy (paclitaxel, carboplatin, and pemetrexed) is used before surgery in the trial. This regimen is being evaluated to see if it can safely shrink tumors enough to make surgery possible and to increase the chance of removing all cancer cells.

What is already known about the treatment

  • Paclitaxel

    Paclitaxel is given by slow intravenous infusion into a vein. It is an approved chemotherapy drug that has been used for many years in cancer treatment. It is mainly used together with other drugs to treat non‑small cell lung cancer and other solid tumors. Paclitaxel works by binding to cell “tubes” called microtubules and keeping them from breaking down, which stops cancer cells from dividing; it belongs to the taxane class of antineoplastic agents.

  • Carboplatin

    Carboplatin is administered by intravenous infusion into a vein. It is an established chemotherapy agent that is widely approved and described in medical literature. It is commonly combined with other drugs to treat non‑small cell lung cancer and other cancers. Carboplatin damages the DNA inside cells by forming cross‑links, preventing the cells from copying their genetic material; it is classified as a platinum‑based alkylating agent.

  • Pemetrexed

    Pemetrexed is delivered by intravenous infusion into a vein. It is an approved chemotherapy medication with extensive use in clinical practice. It is indicated for the treatment of non‑small cell lung cancer, often together with platinum drugs. Pemetrexed blocks several enzymes needed for making DNA and RNA, which stops cancer cells from growing; it is a multitargeted antifolate antimetabolite.

  • PF‑08634404

    PF‑08634404 is given as a concentrate for solution that is infused intravenously into a vein. It is an investigational drug currently being studied in early‑phase clinical trials and is not yet approved for general use. The study is testing it as a single agent or in combination for early‑stage or locally advanced non‑small cell lung cancer. PF‑08634404 works by selectively inhibiting a protein called PI3‑kinase that helps cancer cells survive and grow, placing it in the class of targeted kinase inhibitors.

Investigated diseases

Early-stage resectable or locally advanced unresectable non‑small cell lung cancer - It is a type of lung cancer that starts in the cells lining the airways. In early stage, the tumor is confined to the lung and may be removed by surgery. When locally advanced but unresectable, the tumor has spread to nearby structures making surgery impossible, but it has not spread to distant organs. The disease can grow slowly or faster, invading surrounding tissue and lymph nodes. Over time, it may become more extensive, potentially reaching distant sites.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524825-42-00Protocol codeC6461010Estimated enrolment120 patientsSponsorPfizer Inc.

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