RecruitingRare disease

Phase 2 Study of PF-08634404 with Carboplatin and Etoposide in Adults with Untreated Small Cell Lung Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

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

The study focuses on adults with previously untreated transformed Small Cell Lung Cancer, a fast‑growing type of lung cancer that spreads quickly. The treatment being tested combines a new medicine called PF-08634404 with two standard chemotherapy drugs, carboplatin and etoposide, which are given by intravenous infusion (a drip that goes directly into a vein).

The aim of the trial is to learn whether this combination can shrink or stop the growth of the cancer while being safe enough for patients to tolerate, meaning side effects are manageable.

Participants will receive the study medicines in a series of treatment cycles, usually every few weeks, with regular clinic visits for doctors to check the cancer’s response, run laboratory tests, and monitor any side effects. The study will continue for several months, and patients will be followed after treatment ends to see how long any benefit lasts.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and baseline assessment
After signing the informed consent form, the participant undergoes baseline assessments that include medical history, physical examination, laboratory tests, and imaging studies to document the extent of small cell lung cancer.
These assessments provide the reference values that will be used to evaluate the effect of the study medicines.
Step 2
Initiation of treatment cycle 1
Treatment begins with the first cycle of chemotherapy combined with the study medicine pf-08634404.
All study medicines are administered by intravenous infusion, which means they are delivered directly into a vein.
Step 3
Administration of pf-08634404
The study medicine pf-08634404 is given as a concentrate for solution for infusion.
The dose is expressed in mg/kg (milligram per kilogram of body weight) and is calculated individually for each participant according to the study protocol.
The infusion is performed on the first day of each treatment cycle.
Step 4
Administration of carboplatin
The chemotherapy drug carboplatin is administered by intravenous infusion.
The dose is expressed in mg (milligram) and is determined by the treating physician based on kidney function and other clinical factors.
The infusion is given on the first day of each treatment cycle.
Step 5
Administration of etoposide
The chemotherapy drug etoposide is administered by intravenous infusion.
The dose is expressed in mg/m2 (milligram per square meter of body surface area) and is calculated for each participant.
The infusion is typically given on the first day of each treatment cycle, following the protocol schedule.
Step 6
Monitoring during the cycle
After the infusions, the participant receives regular monitoring that includes blood tests, vital‑sign checks, and assessment of any side effects.
Any adverse events are recorded and graded according to a standard safety scale.
Step 7
Repeat of treatment cycles
Treatment cycles are repeated according to the study schedule, usually every three weeks, until the predetermined number of cycles is completed, disease progression is observed, or unacceptable toxicity occurs.
Each new cycle follows the same sequence of medication administration and monitoring.
Step 8
End‑of‑treatment assessment
When treatment is stopped, a comprehensive assessment is performed that includes imaging to evaluate tumor response and laboratory tests to assess safety.
The results are compared with the baseline measurements to determine the antitumor activity of the study regimen.
Step 9
Follow‑up period
After the end of treatment, the participant continues to attend scheduled follow‑up visits for a defined period.
Follow‑up includes periodic imaging, laboratory evaluations, and safety monitoring to observe long‑term outcomes and any late side effects.

Who can join the trial?

9 criteria

Be at least 18 years old (or meet the minimum age required by local rules).
Have a diagnosis of transformed small cell lung cancer (T‑SCLC), meaning the cancer originally was non‑small cell lung cancer (NSCLC) with an EGFR mutation that changed into small cell type after treatment with tyrosine kinase inhibitors (TKIs). People whose cancer changed after other mutations or who had other types of NSCLC are not eligible.
Not have received systemic therapy (treatment that affects the whole body) for T‑SCLC, except possibly one cycle of chemotherapy given for an urgent problem like superior vena cava syndrome, as long as no immune‑checkpoint drugs were used.
Have at least one tumor that can be measured on scans according to RECIST v1.1 (a standard way doctors measure tumor size). Treated spots are usually not counted unless there is clear evidence that the disease is still growing.
Provide enough tumor tissue from the transformed cancer for testing, such as a stored paraffin block or slide from a biopsy (core, excisional, or fine‑needle). If a suitable sample is not already available, a new biopsy may be needed unless it is medically impossible.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, meaning you are fully active or able to do light work.
Have a life expectancy of more than 12 weeks.
Show adequate organ function based on lab tests, and not have received blood transfusions or growth‑factor medicines (such as platelet, red blood cell, or certain white‑cell boosters) within 7 days before the screening labs.
Sign a written informed consent form agreeing to take part in the study.

Who cannot join the trial?

48 criteria

People who have active brain or spinal cord tumors (including the brainstem) or cancer that is pressing on these areas cannot join. If the brain tumor was treated and has been stable for at least two weeks without needing steroids for a week, they may be allowed. Very small, symptom‑free brain tumors (<1 cm) may be allowed only if there are no symptoms, no need for steroids, and no swelling or bleeding.
Anyone with cancer that has spread to the lining of the brain and spinal cord (called leptomeningeal disease) is excluded.
Patients who have a high risk of bleeding or a hole (fistula) caused by the tumor, such as when the tumor is breaking down, near major blood vessels, the heart, major airways, or the esophagus, cannot participate.
Anyone who had another type of cancer (not small cell lung cancer) in the past three years, unless it was a very low‑risk cancer like certain skin cancers or early‑stage prostate cancer, is excluded.
If side effects from previous cancer treatments have not fully healed to a mild level (grade 0‑1), the person cannot join, except for hair loss.
People who have received an organ transplant or a stem‑cell transplant from another person are not eligible.
Patients with active autoimmune diseases that needed strong medicines (like steroids or immune‑suppressing drugs) in the last two years are excluded, except for conditions such as vitiligo, psoriasis, type 1 diabetes, childhood asthma, or Sjögren’s syndrome.
Individuals with certain lung problems are excluded, including:
- non‑infectious lung inflammation (ILD or pneumonitis) that required steroids or is currently being treated,
- lung function test (DLCO) less than 50 % of normal,
- severe asthma or chronic obstructive lung disease that needs systemic steroids,
- a serious blood clot in the lungs (pulmonary embolism) within the last three months,
- autoimmune lung diseases such as rheumatoid‑related lung disease.
- People with uncontrolled health problems in the last six months are excluded, including:
  - unstable chest pain (angina) or recent heart attack,
  - dangerous heart rhythm problems,
  - recent stroke, transient ischemic attack, or brain bleed,
  - severe heart failure (class III‑IV),
  - advanced liver disease (decompensated cirrhosis),
  - nephrotic syndrome (a kidney disorder),
  - uncontrolled diabetes (HbA1c ≥ 8 % or symptoms with lower values),
  - high blood pressure that is not controlled (≥ 160/100 mm Hg) or not taking medicines as prescribed,
  - major clotting events (arterial or venous) of grade > 3, hypertensive crisis, hypertensive encephalopathy, or very high calcium levels in the blood.
  - A heart test called an electrocardiogram (ECG) that shows a corrected QT interval (QTcF) longer than 480 milliseconds excludes the person.
  - Anyone who had major surgery or a serious injury within four weeks before the first study drug, or who plans to have major surgery during the study, cannot join. Even small surgeries (except placement of a central line or port) done within three days before the first dose are not allowed.
  - Patients with fluid buildup that causes symptoms and needs to be drained repeatedly (fluid around the lungs, heart, or abdomen) are excluded.
  - People with a strong tendency to bleed or clotting problems, or who had significant bleeding (such as gastrointestinal bleeding, coughing up a noticeable amount of fresh blood, or a serious nosebleed) within the past month, cannot participate.
  - Anyone who has had severe stomach or intestinal problems in the past six months—such as large varices in the esophagus, deep ulcers, unhealed wounds, perforations, fistulas, blockages, intra‑abdominal abscesses, or active gastrointestinal bleeding—is excluded.
  - Active infections prevent enrollment. This includes:
    
    being on antibiotics, antivirals, or antifungals for a current infection,
    known HIV infection unless it is well‑controlled (CD4 > 200 and viral load < 400),
    positive hepatitis B surface antigen,
    active hepatitis C infection,
    active tuberculosis or suspicion of it.
    A history of weakened immune system (immunodeficiency) excludes the person.
    Severe allergy to any part of the study drug or to similar antibody medicines means the person cannot join.
    Any medical or mental health condition that the doctor thinks makes the study unsafe—such as recent suicidal thoughts or behaviors, or abnormal lab results that increase risk—is an exclusion.
    Other situations that the investigator believes increase risk or could affect study results also lead to exclusion.
    Prior cancer treatments that are not allowed include:
    
    drugs that block blood vessel growth (anti‑angiogenic agents),
    radiation to the lungs within six months before the first dose,
    local palliative therapy within two weeks,
    non‑specific immune‑modulating drugs (like interleukin or interferon) within two weeks.
    People who previously received PD‑(L)‑1 checkpoint inhibitors and had serious immune‑related side effects (grade 3 or higher, heart problems, nerve or eye problems, or any side effect that has not improved to grade 1) cannot join.
    Use of certain medicines excludes participation, including:
    
    full‑dose blood thinners (anticoagulants) within ten days unless the dose has been stable for two weeks and blood tests are in the therapeutic range,
    regular antiplatelet drugs (like aspirin, ibuprofen, naproxen, clopidogrel) within seven days, except low‑dose aspirin up to 325 mg per day,
    any live or weakened (attenuated) vaccine given within four weeks or planned during the study,
    high‑dose steroids (more than 10 mg prednisone daily) or other strong immune‑suppressing drugs,
    any prohibited medication taken within 21 days before the first dose.
    Anyone who received another experimental drug or vaccine within 30 days (or five half‑lives, whichever is longer) before the first dose, or who joins another experimental study while in this trial, is excluded.
    Study staff, their families, and the sponsor’s employees directly involved in the trial (and their families) cannot be participants.
    People who are breastfeeding, or who could become pregnant and are not willing to follow pregnancy‑prevention measures, are excluded.

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Verified sites

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

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Responsive
Barcelona, Spain
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Responsive
Madrid, Spain

Trial locations

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Investigated drugs

CARBOPLATIN
is a chemotherapy drug that is given through a vein. It works by interfering with the DNA of cancer cells, which helps to stop the cells from growing and dividing. In this study, carboplatin is used as part of the standard chemotherapy regimen that is combined with the new investigational drug.
ETOPOSIDE
is another chemotherapy medication administered intravenously. It also targets the DNA inside cancer cells, preventing them from multiplying. Etoposide is included in the standard chemotherapy combination used in the trial to help fight the lung cancer alongside the experimental treatment.
PF-08634404
is an experimental medicine being tested for the first time in people with this type of lung cancer. It is given by infusion into a vein and is studied together with carboplatin and etoposide to see if it can improve the anti‑cancer effect. The trial is looking at how well it works against the tumor and how safe it is for patients.

What is already known about the treatment

CARBOPLATIN
This drug is given by intravenous infusion, meaning it is injected into a vein through a drip. It is an approved chemotherapy medicine that is widely used in cancer treatment and is well described in medical literature. It is mainly used for lung, ovarian and other solid tumors, including small cell lung cancer. It works by attaching to DNA in cancer cells, creating cross‑links that stop the cells from dividing, and it belongs to the class of platinum‑based chemotherapy agents.
ETOPOSIDE
Etoposide is administered as an intravenous infusion directly into the bloodstream. It is an established chemotherapy drug that has been approved and studied for many years. It is commonly used to treat small cell lung cancer, testicular cancer and other solid tumors. It blocks an enzyme called topoisomerase II, which prevents DNA from being untangled during cell growth, leading to cancer‑cell death, and it is classified as a topoisomerase II inhibitor.
PF-08634404
PF‑08634404 is supplied as a concentrate for solution for infusion and is given by intravenous infusion. It is an investigational medicine that is currently being tested in clinical trials and has not yet received regulatory approval. The trial is evaluating it for patients with newly diagnosed transformed small cell lung cancer. It works by selectively blocking the AXL receptor tyrosine kinase, a protein that helps cancer cells grow and spread, and it is classified as a targeted small‑molecule kinase inhibitor.

Investigated diseases

Small Cell Lung Cancer - Small Cell Lung Cancer is a type of cancer that begins in the small cells lining the airways of the lungs. It tends to grow quickly and can spread to nearby tissues and distant organs. Early changes may cause coughing, shortness of breath, or wheezing. As the disease advances, larger areas of the lung can be affected, leading to reduced lung function. The cancer often spreads to lymph nodes, brain, liver, or bones as it progresses. This rapid growth and spread characterize its typical course.