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Study Comparing Ceralasertib and Durvalumab with Docetaxel for Patients with Advanced Non-Small Cell Lung Cancer After Previous Treatments

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

This clinical trial is focused on studying treatments for advanced or metastatic non-small cell lung cancer, a type of lung cancer that has spread beyond the lungs. The study is comparing two different treatment options for patients whose cancer has progressed after previous treatments. One option is a combination of two medications: ceralasertib and durvalumab. Ceralasertib, also known by its code name AZD6738, is a medication taken orally in the form of a film-coated tablet. Durvalumab is given as an infusion, which means it is administered directly into the bloodstream through a vein. The other treatment option being studied is docetaxel, a medication also given as an infusion.

The purpose of this study is to determine if the combination of ceralasertib and durvalumab is more effective than docetaxel in treating patients with this type of lung cancer. Participants in the study will be randomly assigned to receive either the combination therapy or docetaxel. The study will monitor the overall survival of participants, which refers to the length of time patients live after starting the treatment. Other aspects being evaluated include how long the cancer stays under control, the quality of life reported by participants, and the safety and tolerability of the treatments.

The study will take place over a period of time, with participants receiving treatment for up to 24 months. During this time, participants will have regular check-ups and assessments to monitor their health and the progress of their cancer. The study aims to provide valuable information on the effectiveness and safety of these treatments for patients with advanced or metastatic non-small cell lung cancer.

The research process

The trial runs in 7 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, eligibility is confirmed based on specific criteria such as age, medical history, and current health status.

    A negative pregnancy test is required for women of childbearing potential.

    Documentation of advanced or metastatic non-small cell lung cancer (NSCLC) is necessary.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups: ceralasertib plus durvalumab or docetaxel.

    This process ensures that each participant has an equal chance of receiving either treatment.

  3. Step 3

    Treatment with ceralasertib plus durvalumab

    If assigned to this group, ceralasertib is taken orally in the form of film-coated tablets.

    Durvalumab is administered intravenously as a solution for infusion.

    The treatment schedule and dosage are determined by the study protocol and medical team.

  4. Step 4

    Treatment with docetaxel

    If assigned to this group, docetaxel is administered intravenously as a solution for infusion.

    The treatment schedule and dosage are determined by the study protocol and medical team.

  5. Step 5

    Monitoring and assessments

    Regular monitoring of health status and response to treatment is conducted.

    Assessments include physical examinations, imaging tests, and laboratory tests.

    Participant-reported outcomes such as quality of life and physical functioning are also evaluated.

  6. Step 6

    End of treatment

    The treatment phase concludes as per the study protocol or if the participant decides to withdraw.

    Final assessments are conducted to evaluate the overall response to the treatment.

  7. Step 7

    Follow-up

    Participants enter a follow-up phase to monitor long-term health outcomes.

    This phase includes periodic health assessments and may continue for a specified duration after the treatment ends.

Who can join the trial?

10 criteria

  • Participant must be at least 18 years old at the time of screening.
  • Women of childbearing potential must have a negative pregnancy test. This means a test to confirm they are not pregnant.
  • Must have a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC) that is either advanced or has spread to other parts of the body.
  • Must not have certain genetic changes in their cancer, specifically EGFR and ALK wild-type status, which means these genes are normal and not mutated.
  • Must have evidence of cancer progression, meaning the cancer has grown or spread, after the most recent treatment.
  • Eligible for second- or third-line therapy, meaning they have already tried one or two other treatments. They must have received a specific type of treatment called anti-PD-(L)1 therapy and a treatment that includes platinum, either separately or together.
  • Must have a performance status of 0 or 1 on the ECOG/WHO scale, which means they are fully active or have some symptoms but can still do light work.
  • Must have adequate organ function and enough healthy blood cells.
  • Must have a minimum life expectancy of 12 weeks, meaning they are expected to live at least 12 more weeks.
  • Must weigh more than 30 kg (about 66 pounds) and not have severe weight loss due to cancer, known as cancer-associated cachexia.

Who cannot join the trial?

4 criteria

  • Patients who have not received second- or third-line therapy for their lung cancer.
  • Patients with lung cancer that has specific genetic changes that can be targeted by other treatments.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population that the study is not designed to include.
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Investigated drugs

  • Ceralasertib

    is a medication being studied for its potential to help treat advanced non-small cell lung cancer. It is being tested in combination with another drug to see if it can improve outcomes for patients whose cancer has progressed after previous treatments.

  • Durvalumab

    is an immunotherapy drug that helps the body's immune system attack cancer cells. It is being used in combination with ceralasertib to see if this combination can be more effective in treating advanced non-small cell lung cancer.

  • Docetaxel

    is a chemotherapy drug that is commonly used to treat various types of cancer, including lung cancer. In this study, it is being used as a comparison to evaluate the effectiveness of the ceralasertib and durvalumab combination.

What is already known about the treatment

  • Ceralasertib

    Ceralasertib is administered orally and is currently being studied in clinical trials for its potential use in treating advanced or metastatic non-small cell lung cancer (NSCLC). It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication for ceralasertib is in combination with other treatments for NSCLC, particularly in patients whose disease has progressed after prior therapies. At the molecular level, ceralasertib works by inhibiting a specific enzyme involved in DNA damage repair, which can enhance the effectiveness of other cancer treatments. It is classified as a kinase inhibitor in pharmacology.

  • Durvalumab

    Durvalumab is administered via intravenous infusion and is an established medication in the treatment of certain types of cancer, including advanced or metastatic non-small cell lung cancer (NSCLC). It is used primarily in patients whose cancer has progressed after previous treatments. Durvalumab works by blocking a protein that prevents the immune system from attacking cancer cells, thereby enhancing the body's immune response against the tumor. It is classified as an immune checkpoint inhibitor in pharmacological terms.

  • Docetaxel

    Docetaxel is administered through intravenous infusion and is a well-known chemotherapy drug used in the treatment of various cancers, including advanced or metastatic non-small cell lung cancer (NSCLC). It is typically used when other treatments have failed to control the disease. Docetaxel works by disrupting the normal function of microtubules in cells, which are essential for cell division, thereby inhibiting cancer cell growth. It is classified as a taxane-based chemotherapy agent.

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 spread beyond the lungs to other parts of the body. It is the most common form of lung cancer, accounting for a significant majority of cases. The disease progresses as cancer cells grow uncontrollably, forming tumors that can invade nearby tissues and organs. In its advanced or metastatic stage, the cancer has spread to distant parts of the body, such as the bones, brain, or liver. This progression can lead to a variety of symptoms, including persistent cough, chest pain, and difficulty breathing. The disease's advancement is often marked by the cancer's resistance to initial treatments, necessitating further therapeutic strategies.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509429-37-00Protocol codeD533BC00001Estimated enrolment892 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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