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Study of SKB264 and Pembrolizumab for Treating Patients with 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

This clinical trial is focused on studying the treatment of advanced or metastatic non-small cell lung cancer (NSCLC). The study will explore the use of a medication called SKB264, which is an antibody-drug conjugate. This type of treatment combines an antibody, which can specifically target cancer cells, with a drug that can kill these cells. The trial will assess the safety and how well patients tolerate SKB264 when used alone or in combination with other treatments. The goal is to understand how effective SKB264 is in treating NSCLC and to observe the response rate, which refers to how well the cancer responds to the treatment.

Participants in the study will receive SKB264 through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of up to 75 days, during which participants will be closely monitored for any side effects and the effectiveness of the treatment. The study will also include a comparison with a placebo to better understand the effects of SKB264. The trial aims to provide valuable information on the potential benefits of SKB264 for patients with advanced stages of NSCLC.

In addition to SKB264, the study will involve other medications such as carboplatin, a chemotherapeutic agent, and osimertinib, which is used for certain types of lung cancer. These medications will be used in combination with SKB264 to evaluate their combined effects on the cancer. The study will help determine the best treatment options for patients with NSCLC, focusing on improving their quality of life and extending survival. Participants will be required to visit the study site regularly for assessments and to receive their treatments.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be required to provide informed consent, confirming their understanding and agreement to participate in the trial.

    Eligibility will be confirmed based on specific criteria, including age, health status, and previous treatments.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate the participant's health status and ensure all eligibility criteria are met.

    This assessment may include medical history review, physical examination, and laboratory tests.

  3. Step 3

    Treatment phase

    Participants will receive the study medication SKB264 as a monotherapy or in combination with other treatments.

    The medication will be administered through intravenous use as a solution for infusion.

    The dosage and frequency will be determined by the study protocol and adjusted based on the participant's response and tolerance.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will be conducted to assess the participant's response to the treatment and to identify any side effects.

    This will include scheduled visits for physical examinations, laboratory tests, and imaging studies as needed.

  5. Step 5

    End of treatment

    Upon completion of the treatment phase, a final assessment will be conducted to evaluate the overall response to the study medication.

    Participants will be informed of the results and any further steps or follow-up care required.

Who can join the trial?

12 criteria

  • Participants must be at least 18 years old when they sign the consent form, regardless of gender.
  • Participants must have a **left ventricular ejection fraction (LVEF)** of 50% or higher. This is a measure of how well the heart pumps blood.
  • Participants should have recovered from any side effects of previous treatments, except for those that are not considered a safety risk, like hair loss or skin changes.
  • Participants must use birth control methods that follow local regulations for clinical study participants.
  • Participants should willingly join the study, sign the consent form, and be able to attend study visits and follow procedures.
  • Participants must have **non-small cell lung cancer (NSCLC)** that is either locally advanced or has spread to other parts of the body and cannot be treated with surgery or radiation.
  • For certain groups, participants must have specific genetic characteristics of their cancer, such as being **EGFR wild-type** or having specific **EGFR mutations**. These are specific changes in the cancer cells that affect treatment options.
  • Participants must be able to provide samples of their tumor before starting the study treatment.
  • Participants must have at least one tumor that can be measured using imaging tests, but brain tumors cannot be used for this purpose.
  • Participants must have an **ECOG performance status** of 0 or 1, which means they are fully active or have some symptoms but can still do light work. This is assessed within 7 days before starting the study treatment.
  • Participants must have a life expectancy of at least 3 months.
  • Participants must have adequate organ function, as shown by lab tests.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not reached the required age range for the study.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have a medical condition that could interfere with the study results.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who have a history of certain heart conditions.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of drug or alcohol abuse.
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Investigated drugs

SKB264 is an investigational medication being studied for its potential use in treating advanced or metastatic non-small cell lung cancer (NSCLC). The trial aims to assess how safe and tolerable this medication is when used alone or in combination with other treatments. Additionally, the study seeks to determine how effective SKB264 is in shrinking or eliminating tumors in patients with this type of lung cancer.

What is already known about the treatment

SKB264 – This medication is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating advanced or metastatic non-small cell lung cancer. The main therapeutic use of SKB264 is to help manage this type of lung cancer, particularly in advanced stages. At the molecular level, SKB264 works by targeting specific proteins on cancer cells, which may help to slow down or stop the growth of these cells. It is classified as an investigational drug, meaning it is still under research and not yet approved for general medical use.

Investigated diseases

Advanced or Metastatic Non-small Cell Lung Cancer – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by its ability to spread to other parts of the body. It is termed "non-small cell" to distinguish it from small cell lung cancer, which behaves differently. In its advanced or metastatic stages, the cancer has spread beyond the lungs to other organs or tissues. The progression of this disease can vary, but it often involves the growth of tumors in the lungs and potentially other areas. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the disease advances, it can lead to more severe respiratory issues and other systemic symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507270-41-00Protocol codeSKB264-II-04Estimated enrolment498 patientsSponsorSichuan Kelun-Biotech Biopharmaceutical Co. Ltd.

sourced from the EU Clinical Trials Register and site verification

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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).