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Study of alectinib, pemetrexed, carboplatin and cisplatin in patients with resectable stage I-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 focuses on patients with Non-Small Cell Lung Cancer (NSCLC) in stages I-III that can be surgically removed. The study will test different treatment combinations, including alectinib with chemotherapy drugs such as pemetrexed, carboplatin, and cisplatin. The treatments will be selected based on specific biological markers in the patients' cancer cells.

The study consists of two groups. In one group, patients will receive treatment after their cancer has been surgically removed. In the other group, patients will receive treatment before surgery. The medications will be given either by mouth or through an intravenous infusion. The treatment period may last up to 63 months, depending on the group.

The researchers will monitor how well the treatments work and track any side effects that may occur. They will measure how many patients have their cancer completely disappear after treatment and how long patients live without their cancer returning. The study will also look at overall survival and the safety of the treatment combinations.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial diagnosis and group assignment

    You have been diagnosed with non-small cell lung cancer (NSCLC) at stage I-III that can be surgically removed

    Based on your test results, you will be assigned to one of two groups: Cohort B1 (after surgery) or Cohort B2 (before surgery)

    Your cancer must test positive for a specific marker called ALK fusion

  2. Step 2

    Treatment path for Cohort B1 (post-surgery)

    If assigned to Cohort B1, you will first undergo surgery to remove the cancer

    After surgery, you will receive a combination of treatments:

    - Alectinib capsules taken by mouth

    - Chemotherapy medications (pemetrexed, carboplatin, or cisplatin) given through an IV infusion

    Your doctor will monitor for side effects for 28 days after the last chemotherapy treatment

  3. Step 3

    Treatment path for Cohort B2 (pre-surgery)

    If assigned to Cohort B2, you will first receive treatment before surgery:

    - Alectinib capsules taken by mouth

    - Chemotherapy medications (pemetrexed, carboplatin, or cisplatin) given through an IV infusion

    After completing the initial treatment, you will undergo surgery to remove the cancer

    Surgery should take place within 60 days of your last pre-surgery treatment

  4. Step 4

    Follow-up period

    Regular check-ups to monitor your recovery and response to treatment

    Your doctor will perform tests to check your vital signs, take blood samples, and conduct heart monitoring (ECG)

    The study will continue monitoring participants until July 2033

Who can join the trial?

10 criteria

  • Age requirement: Adults (age 18 and older)
  • Both men and women can participate
  • Must have non-small cell lung cancer (NSCLC) that can be surgically removed, specifically the type called adenocarcinoma
  • Must have a confirmed ALK fusion (a specific genetic change in the cancer cells)
  • Must be in relatively good physical condition with an ECOG score of 0 or 1 (able to perform daily activities with little or no assistance)
  • For patients after surgery (Cohort B1):
    • Must have had complete removal of the cancer with clear margins (no cancer cells at the edges of removed tissue)
    • Must have Stage II to selected Stage IIIB cancer
    • For patients before surgery (Cohort B2):
      • Must be considered suitable for complete surgical removal of the cancer
      • Must have confirmed Stage II to Stage IIIB cancer
      • Must be evaluated by both a surgeon and cancer doctor before joining the study

Who cannot join the trial?

13 criteria

  • Previous treatment with any ALK inhibitor (medications that target a specific protein called ALK)
  • History of severe allergic reactions to study medications
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Significant heart problems, including uncontrolled high blood pressure or recent heart attack
  • Severe liver problems or abnormal liver function tests
  • Active or uncontrolled infections, including hepatitis B, hepatitis C, or HIV
  • Other types of cancer within the past 5 years (except for appropriately treated skin cancer or cervical cancer)
  • Pregnant or breastfeeding women
  • Any condition that would make it unsafe to participate in the study or interfere with the evaluation of the study treatment
  • Unable to swallow oral medications
  • Known hypersensitivity to the components of chemotherapy drugs used in the study
  • Mental conditions that would prevent understanding of the study requirements
  • Regular use of medications that could interact with the study drugs
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Investigated drugs

  • Alectinib

    is a targeted therapy medication used to treat certain types of non-small cell lung cancer (NSCLC). It specifically works by blocking a protein called ALK (anaplastic lymphoma kinase) that helps cancer cells grow and spread. This medication is taken orally and is designed to target cancer cells while minimizing damage to healthy cells.

  • Chemotherapy

    refers to medications that kill cancer cells or stop them from growing. It works throughout the body to destroy cancer cells. In this trial, chemotherapy is used in combination with alectinib to treat early-stage lung cancer that can be surgically removed.

What is already known about the treatment

Alectinib – An oral medication used in the treatment of non-small cell lung cancer (NSCLC), specifically for patients with ALK-positive tumors. This targeted therapy works by blocking the ALK protein that drives cancer growth, effectively slowing down or stopping the progression of cancer cells. Alectinib is administered in capsule form and belongs to the class of tyrosine kinase inhibitors, showing particular effectiveness in early-stage resectable NSCLC when combined with chemotherapy. The medication has demonstrated significant clinical benefits in both pre-surgical (neoadjuvant) treatment and post-surgical (adjuvant) therapy for Stage II-IIIB lung cancer patients.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – A type of lung cancer that begins in the cells of the lungs and forms large malignant cells. It develops in the outer parts of the lungs and grows more slowly than small cell lung cancer. The disease typically starts in the cells that line the airways of the lungs, gradually spreading to nearby tissues. NSCLC can be classified into different stages (I through III) based on the size of the tumor and whether it has spread to nearby structures. In resectable cases, the tumor can be surgically removed.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511239-91-00Protocol codeBO43249Estimated enrolment150 patientsSponsorF. Hoffmann-La Roche AG

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