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Study on the Effectiveness and Safety of Alectinib, Entrectinib, and a Drug Combination for Patients with Advanced or Metastatic 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 advanced or metastatic non-small cell lung cancer (NSCLC), a type of lung cancer that has spread beyond the lungs. The study aims to evaluate the effectiveness and safety of several targeted therapies. These therapies include alectinib for patients with specific genetic changes known as ALK+ or RET+, entrectinib for those with ROS1+ mutations, and a combination of atezolizumab, cobimetinib, and vemurafenib for patients with BRAF V600+ mutations. Additionally, the study will assess the combination of atezolizumab, bevacizumab, carboplatin, and pemetrexed for patients with EGFR exon 20+ mutations.

The purpose of the study is to determine how well these treatments work in patients whose cancer has specific genetic mutations detected through a blood test. Participants will receive one of the targeted therapies or a combination of therapies, depending on their specific genetic profile. Some patients may receive a placebo as part of the study. The treatments will be administered either orally or through intravenous infusion, depending on the medication. The study will monitor the participants' response to the treatment, including any side effects they may experience.

Throughout the study, participants will undergo regular check-ups and tests to track their progress and ensure their safety. The study will last for a period of time, during which the effectiveness of the treatments will be evaluated. The goal is to find the most effective treatment options for patients with advanced or metastatic NSCLC, based on their unique genetic makeup.

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, a diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC) is confirmed.

    Eligibility is determined based on specific criteria, including measurable disease and adequate organ function.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current health status and establish a baseline for the study.

    This includes various tests and measurements to ensure readiness for the trial.

  3. Step 3

    Treatment assignment

    Based on specific genetic markers, a treatment plan is assigned.

    Possible treatments include alectinib, entrectinib, atezolizumab combined with other medications, or vemurafenib.

  4. Step 4

    Treatment administration

    Medications are administered according to the assigned treatment plan.

    Oral medications such as alectinib and entrectinib are taken as film-coated tablets or capsules.

    Intravenous medications like atezolizumab are given through infusions.

  5. Step 5

    Ongoing monitoring

    Regular monitoring is conducted to assess the effectiveness and safety of the treatment.

    This includes tracking any side effects and adjusting the treatment as necessary.

  6. Step 6

    Follow-up assessments

    Periodic assessments are performed to evaluate the response to treatment.

    These assessments help determine the overall progress and any necessary changes to the treatment plan.

  7. Step 7

    Completion of the study

    Upon completion of the study, a final assessment is conducted to evaluate the outcomes.

    The results contribute to understanding the efficacy and safety of the treatments for NSCLC.

Who can join the trial?

7 criteria

  • Must have a confirmed diagnosis of **advanced** or **metastatic** non-small cell lung cancer (NSCLC). This means the cancer is in a late stage and has spread to other parts of the body.
  • The cancer must be **unresectable**, meaning it cannot be removed with surgery, and classified as Stage IIIb or Stage IV.
  • Must have **measurable disease**. This means the cancer can be measured in size using specific criteria called RECIST, version 1.1.
  • Must have **adequate recovery** from the most recent cancer treatment, whether it was a drug treatment or a local treatment like radiation.
  • Must have **adequate organ function**, meaning the organs are working well enough to handle the treatment.
  • Must have a **life expectancy** of at least 12 weeks, meaning the doctors expect the patient to live for at least 3 more months.
  • Female patients who can have children and male patients must be willing to use **acceptable methods of contraception** to prevent pregnancy during the study.

Who cannot join the trial?

6 criteria

  • Patients who have a different type of cancer other than Non-small cell lung cancer (NSCLC).
  • Patients who are not in the advanced or metastatic stage of NSCLC. This means the cancer has not spread to other parts of the body.
  • Patients who are not selected based on specific test results from the FoundationOne Liquid Companion Diagnostic (F1LCDx).
  • Patients who are not within the specified age range for the study.
  • Patients who are not eligible based on gender, as the study includes both male and female participants.
  • Patients who belong to a vulnerable population that is not selected for this study.
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Investigated drugs

  • Alectinib

    is a medication used in this trial for patients with non-small cell lung cancer (NSCLC) who have specific genetic changes known as ALK or RET mutations. It works by targeting and blocking the proteins produced by these mutations, which can help slow down or stop the growth of cancer cells.

  • Entrectinib

    is another targeted therapy in the trial, used for patients with NSCLC who have ROS1 mutations. This medication helps to inhibit the activity of the ROS1 protein, which can contribute to the growth and spread of cancer cells.

  • Atezolizumab

    is an immunotherapy drug included in the trial. It is used in combination with other medications to help the immune system recognize and attack cancer cells more effectively. In this study, it is combined with other drugs for patients with specific genetic mutations in their cancer.

  • Cobimetinib

    is used alongside atezolizumab and vemurafenib for patients with BRAF V600 mutations. It works by blocking certain proteins that promote cancer cell growth, enhancing the effects of the other medications in the combination.

  • Vemurafenib

    is part of the combination therapy with atezolizumab and cobimetinib for patients with BRAF V600 mutations. It specifically targets and inhibits the activity of the BRAF protein, which is involved in cell growth and division.

  • Bevacizumab

    is used in combination with atezolizumab, carboplatin, and pemetrexed for patients with EGFR exon 20 mutations. It works by inhibiting the growth of blood vessels that supply nutrients to tumors, helping to slow down tumor growth.

What is already known about the treatment

  • Alectinib

    Alectinib is administered orally in the form of capsules. It is currently used in the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) with specific genetic mutations. The medication works by inhibiting the activity of certain proteins that promote cancer cell growth. It belongs to the class of drugs known as tyrosine kinase inhibitors.

  • Entrectinib

    Entrectinib is taken orally as capsules. It is used for treating advanced or metastatic NSCLC with specific genetic mutations. The drug functions by blocking the action of proteins involved in the growth and spread of cancer cells. It is classified as a tyrosine kinase inhibitor.

  • Atezolizumab

    Atezolizumab is administered intravenously. It is used in combination with other drugs for treating advanced or metastatic NSCLC. The medication works by helping the immune system recognize and attack cancer cells. It is part of a class of drugs known as immune checkpoint inhibitors.

  • Cobimetinib

    Cobimetinib is taken orally in tablet form. It is used in combination with other medications for treating NSCLC with specific mutations. The drug inhibits certain proteins that contribute to cancer cell growth. It is classified as a MEK inhibitor.

  • Vemurafenib

    Vemurafenib is administered orally as tablets. It is used in combination with other drugs for NSCLC with specific genetic mutations. The medication targets and inhibits proteins that promote cancer cell growth. It belongs to the class of BRAF inhibitors.

  • Bevacizumab

    Bevacizumab is given intravenously. It is used in combination with other drugs for treating advanced or metastatic NSCLC. The drug works by inhibiting the growth of blood vessels that supply nutrients to tumors. It is classified as an angiogenesis inhibitor.

Investigated diseases

Non-small cell lung cancer (NSCLC) – 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. NSCLC typically grows and spreads more slowly than small cell lung cancer. The disease often begins in the cells lining the air passages and can progress to invade nearby tissues and organs. As it advances, it may spread to lymph nodes and other parts of the body. Symptoms can include a persistent cough, chest pain, and difficulty breathing.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-507500-31-00Protocol codeBO29554Estimated enrolment616 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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