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Study on Alectinib and Durvalumab for Patients with Locally Advanced, Unresectable Stage III Non-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

This clinical trial is focused on studying treatments for Non-Small Cell Lung Cancer (NSCLC), which is a type of lung cancer that is common and can be challenging to treat when it reaches an advanced stage. The study will explore the effectiveness and safety of different therapies for patients with locally advanced, unresectable Stage III NSCLC. The treatments being tested include Alecensa (also known by its code name RO5424802), which contains the active substance alectinib, and IMFINZI, which contains the active substance durvalumab. Another treatment option being evaluated is entrectinib, which is a type of medication known as a tyrosine kinase inhibitor.

The purpose of the study is to compare these treatments in patients who have specific biomarkers, which are unique characteristics found in their cancer cells. These patients have already received a combination of chemotherapy and radiation therapy, known as chemoradiotherapy, and have not shown any progression of their disease on imaging tests. The study will assess how well these treatments work in preventing the cancer from getting worse, which is referred to as progression-free survival.

Participants in the study will receive one of the treatments, and some may receive a placebo. The study will monitor the patients over a period of time to observe the effects of the treatments on their cancer and overall health. The trial aims to provide valuable information on the best treatment options for patients with this type of lung cancer, helping to improve future care and outcomes for those affected by NSCLC.

The research process

The trial runs in 6 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, participation begins with a comprehensive evaluation to confirm eligibility. This includes a whole-body PET-CT scan performed within 42 days prior to the first dose of chemoradiotherapy.

    Eligibility requires a diagnosis of locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) and no disease progression after at least two cycles of platinum-based chemoradiotherapy.

  2. Step 2

    Treatment assignment

    Participants are assigned to treatment groups based on specific biomarkers. Those with ALK fusion positivity are placed in Cohort A1, while those with ROS1 fusion positivity are placed in Cohort A2.

    The treatment involves either alectinib or entrectinib for Cohort A2, and durvalumab for comparison.

  3. Step 3

    Medication administration

    For those receiving alectinib, the medication is administered orally in the form of Alecensa 150 mg hard capsules.

    Participants receiving durvalumab will have it administered through intravenous infusion, using IMFINZI 50 mg/mL concentrate for solution for infusion.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess progression-free survival (PFS) and other health indicators. This includes imaging studies and clinical evaluations.

    Secondary assessments include time to central nervous system progression, distant metastasis-free survival, and overall survival, among others.

  5. Step 5

    Patient-reported outcomes

    Participants will report on physical functioning, role functioning, and symptoms such as cough, chest pain, and shortness of breath at specified intervals.

    Quality of life is measured using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) at 5, 11, and 17 months.

  6. Step 6

    Adverse events monitoring

    The incidence, type, and severity of any adverse events are recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0.

    Changes in vital signs, physical findings, and laboratory results are monitored throughout the study.

Who can join the trial?

9 criteria

  • The patient must have a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC).
  • A special scan called a PET-CT must be done on the whole body before and within 42 days of starting a specific cancer treatment.
  • The lung cancer must be at a stage called locally advanced, unresectable Stage III, which means it has spread locally and cannot be removed by surgery. This must be confirmed by examining tissue samples.
  • The patient must not have had any worsening of the disease during or after receiving at least two cycles of a specific type of cancer treatment called platinum-based chemoradiotherapy.
  • The patient must have a specific genetic change called ALK fusion positivity for one group of the study.
  • The patient must have a specific genetic change called ROS1 fusion positivity for another group of the study.
  • The patient must be able to swallow a medication called entrectinib whole, without chewing, crushing, or opening the capsules, for the group with ROS1 fusion positivity.
  • Both male and female patients can participate in the study.
  • The study includes patients who are considered part of a vulnerable population.

Who cannot join the trial?

10 criteria

  • Patients who have had a recent heart attack or severe heart problems.
  • Patients with uncontrolled high blood pressure.
  • Patients who have another type of cancer that is not under control.
  • Patients who are pregnant or breastfeeding.
  • Patients who have an active infection that requires treatment.
  • Patients who have a known allergy to the study drugs.
  • Patients who have had a major surgery within the last 4 weeks.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures.
  • Patients who have received another investigational drug within the last 4 weeks.
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Investigated drugs

  • Alectinib

    is a medication used in this trial to treat patients with a specific type of lung cancer. It works by targeting and blocking certain proteins that help cancer cells grow. This medication is being tested to see how well it works in patients whose cancer has not progressed after receiving other treatments like chemotherapy and radiation.

  • Entrectinib

    is another medication being studied in this trial. It is designed to target and inhibit certain proteins that are involved in the growth and spread of cancer cells. The trial aims to determine its effectiveness in patients with lung cancer who have specific biomarkers and have already undergone treatments such as chemotherapy and radiation.

  • Durvalumab

    is an immunotherapy drug included in this trial. It helps the immune system recognize and attack cancer cells. The study is evaluating how well durvalumab works in comparison to other treatments for patients with advanced lung cancer who have not shown disease progression after previous therapies.

What is already known about the treatment

  • Alectinib

    Alectinib is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating non-small cell lung cancer (NSCLC), particularly in patients with specific biomarkers. The medication works by inhibiting the activity of certain proteins that promote cancer cell growth, specifically targeting the ALK protein. Alectinib is classified as a tyrosine kinase inhibitor, which helps to block the signals that lead to cancer cell proliferation.

  • Entrectinib

    Entrectinib is taken orally as capsules and is under investigation for its potential to treat non-small cell lung cancer (NSCLC) in patients with specific genetic markers. It functions by blocking the action of proteins that encourage cancer cell growth, focusing on the TRK, ROS1, and ALK proteins. Entrectinib belongs to the class of medications known as tyrosine kinase inhibitors, which are designed to interfere with the pathways that allow cancer cells to grow and spread.

  • Durvalumab

    Durvalumab is administered through intravenous infusion and is being evaluated for its role in treating non-small cell lung cancer (NSCLC) in patients who have undergone chemoradiotherapy. It works by enhancing the body's immune response against cancer cells by blocking the PD-L1 protein, which helps cancer cells evade immune detection. Durvalumab is classified as an immune checkpoint inhibitor, a type of medication that helps the immune system recognize and attack cancer cells more effectively.

Investigated diseases

Non-Small Cell Lung Cancer – This is a type of lung cancer that includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of all cases. The disease typically starts in the cells lining the lungs and can grow and spread to other parts of the body. In its early stages, it may not cause noticeable symptoms, but as it progresses, symptoms like persistent cough, chest pain, and shortness of breath may occur. The progression of the disease can vary, with some cases remaining localized while others spread to distant organs. The rate of progression and the specific symptoms can differ based on the subtype and stage of the cancer.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503920-14-00Protocol codeBO42777Estimated enrolment332 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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