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Osimertinib and drug combination in metastatic non‑small cell lung cancer with targetable genomic driver alterations

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Non‑Small Cell Lung Cancer is a common type of lung cancer. When it has spread beyond the lungs it is called metastatic. Some tumors have genomic driver alterations – specific genetic changes that can be targeted with medicines. The study aims to find the best order of using these medicines to keep the disease from growing for as long as possible.

The trial uses several approved medicines that work on different genetic changes. These include the oral pills Lazcluze, Tafinlar, Lorviqua, Mektovi, OSIMERTINIB, Retsevmo, Alunbrig, KRAZATI, and the infusion drugs OPDIVO, Tecentriq, LIBTAYO, Rybrevant. Some are taken by mouth in tablet or capsule form, while others are given through a vein (intravenous infusion). Each medicine is chosen based on the specific genetic alteration present in the tumor.

Participants are assigned to different sequences of these medicines and are followed with regular check‑ups and scans. The main goal is to measure progression free survival at two years, which means the time before the cancer grows or spreads again. Additional outcomes include overall survival (time alive), objective response rate (how many tumors shrink), duration of response (how long shrinkage lasts), treatment‑related adverse events (side effects caused by the drugs), and health‑related quality of life (how patients feel and function). The study follows each person for several years to collect these data.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Oral Medication Administration

    You will take the prescribed oral tablets and capsules according to the study plan. The medications and their doses are:

    Lazcluze: 240 mg film‑coated tablet, taken orally.

    Tafinlar: 300 mg hard capsule, taken orally.

    Lorviqua: 100 mg film‑coated tablet, taken orally.

    Mektovi: 90 mg film‑coated tablet, taken orally.

    Osimertinib: 80 mg tablet, taken orally.

    Retsevmo: 320 mg hard capsule, taken orally.

    Braftovi: 450 mg hard capsule, taken orally.

    Alunbrig: 180 mg film‑coated tablet, taken orally.

    Retsevmo (40 mg): 320 mg hard capsule, taken orally.

    TEPMETKO: 500 mg film‑coated tablet, taken orally.

    KRAZATI: 1200 mg film‑coated tablet, taken orally.

    Alecensa: 1200 mg hard capsule, taken orally.

    Mekinist: 2 mg film‑coated tablet, taken orally.

    Tabrecta: 800 mg film‑coated tablet, taken orally.

    LUMYKRAS: 960 mg film‑coated tablet, taken orally.

  2. Step 2

    Intravenous Infusion Administration

    You will receive intravenous infusions at the clinic or infusion center as scheduled by the study team. The infusion medications and their doses are:

    Vinorelbine: 30 mg/m² solution for infusion, administered intravenously.

    Nivolumab (OPDIVO): 360 mg solution for injection, administered by infusion.

    Atezolizumab (Tecentriq): 1875 mg solution for injection, administered by infusion.

    Cemiplimab (LIBTAYO): 350 mg concentrate for infusion, administered intravenously.

    Ipilimumab (YERVOY): 10 mg/kg concentrate for infusion, administered intravenously.

    Amivantamab (Rybrevant): 1750 mg solution for injection, administered intravenously.

    Cisplatin: 75 mg/m² solution for infusion, administered intravenously.

    Gemcitabine: 1000 mg/m² solution for infusion, administered intravenously.

    Carboplatin: 6 U solution for infusion, administered intravenously.

    Docetaxel: 75 mg/m² solution for infusion, administered intravenously.

    Pemetrexed: 500 mg/m² solution for infusion, administered intravenously.

  3. Step 3

    Study Duration and Follow‑Up

    The study is planned to recruit participants starting on 30 September 2026 and to continue until 31 March 2030. You will remain in the trial for the duration of your assigned treatment sequence and will attend follow‑up visits as required by the protocol.

Who can join the trial?

14 criteria

  • Be 18 years of age or older, regardless of sex.
  • Have normal liver function, meaning total bilirubin (a substance that shows how well the liver works) is no more than 1.5 times the normal upper limit and the liver enzymes AST and ALT are no more than 2.5 times normal (up to 5 times normal if cancer has spread to the liver).
  • Have normal kidney function, shown by a serum creatinine level of 1.5 mg/dL or less, or a calculated creatinine clearance of at least 60 mL/min for men or 50 mL/min for women using the Cockcroft‑Gault formula.
  • Have blood calcium, INR (a test that measures blood clotting) and partial thromboplastin time (another clotting test) all within normal ranges.
  • Be expected to live at least three more months.
  • Be able to understand the study information and sign a written consent form.
  • Have a confirmed diagnosis of Non Small Cell Lung Cancer that is stage IIIB‑C (cannot be removed surgically and not suitable for chemoradiation) or stage IV, as defined by the AJCC version 9.
  • Not have received any treatment for metastatic disease (treatment‑naïve). Prior adjuvant therapy with targeted drugs or checkpoint inhibitors is allowed only if it was finished at least 12 months before randomization and any side effects have returned to baseline or are stable.
  • Have disease that can be measured on a CT (computed tomography) or MRI (magnetic resonance imaging) scan according to RECIST 1.1 criteria (standard rules for measuring tumor size).
  • Show a targetable oncogenic‑driver alteration—such as EGFR, BRAF‑V600E, KRAS G12C mutations, or ALK, RET, MET exon 14 rearrangements—found in tumor tissue or in circulating tumor DNA before enrollment.
  • Have an ECOG performance status of 0, 1, or 2 (meaning fully active to capable of limited self‑care).
  • If you are a woman who could become pregnant, you must have a negative pregnancy test at the start and use reliable birth control during the study and for about 23 weeks after the last dose of study medication.
  • If you are a man who has sexual contact with a woman who could become pregnant, you must use reliable birth control during the study and for about 31 weeks after the last dose of study medication.
  • Have adequate bone‑marrow blood counts: absolute neutrophil count ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L, and hemoglobin ≥ 9 g/dL.

Who cannot join the trial?

16 criteria

  • Currently taking part in another clinical trial that involves an experimental treatment.
  • Has a known infection with HIV (human immunodeficiency virus), which is the virus that can cause AIDS.
  • Has an active hepatitis B infection (positive hepatitis B surface antigen) or an active hepatitis C infection (detectable hepatitis C virus RNA).
  • Has an active autoimmune disease that needed strong medicines such as disease‑modifying drugs, corticosteroids, or other immune‑suppressing medicines in the past two years. (Routine hormone replacements like thyroid hormone, insulin, or normal steroid replacement are not counted.)
  • Has a history of interstitial lung disease, drug‑related lung inflammation (pneumonitis), or radiation‑induced lung inflammation that required steroid treatment.
  • Received a live vaccine (a vaccine that contains a weakened form of the germ) within 14 days before starting the study treatment.
  • Is pregnant, breastfeeding, or plans to become pregnant while receiving the study drug and for 180 days after the last dose.
  • Is a male who plans to donate sperm or father a child while receiving the study drug and for 180 days after the last dose.
  • Has already received any systemic (whole‑body) therapy for advanced cancer before starting the study treatment.
  • Had major surgery within the past three weeks or has not fully recovered from surgery before starting the study treatment.
  • Received radiation therapy within two weeks before the first day of the study treatment.
  • Is allergic (has a serious hypersensitivity reaction) to any part of the study drugs or their inactive ingredients.
  • Has a serious, uncontrolled medical problem, a non‑cancerous systemic disease, or an active infection that is not under control.
  • Was diagnosed with, detected, or treated for another type of cancer within the past two years, except for skin basal or squamous cell cancer or cervical cancer that has been completely treated.
  • Has active, symptomatic cancer spread to the brain or the covering of the brain (leptomeningeal metastases). If brain metastases have been treated, they must show no growth on MRI scans for at least four weeks and the patient must not need high‑dose steroids.
  • Has an immune deficiency or is taking chronic systemic steroids (more than 10 mg of prednisone or an equivalent each day) or any other immune‑suppressing therapy within seven days before starting the study treatment.
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Investigated drugs

  • Lazertinib

    is an oral medicine that blocks a specific mutant protein that can drive cancer growth in some lung cancers. In the study it is tested to see how well it works alone or in sequence with other drugs.

  • Dabrafenib

    is a pill that targets a mutation in the BRAF gene, which can cause tumor cells to grow. The trial evaluates its effect when given before or after other treatments.

  • Vinorelbine

    is a chemotherapy drug given through an IV. It works by stopping cancer cells from dividing, and the study looks at its role in combination or sequencing with targeted therapies.

  • Nivolumab

    is an IV infusion that helps the immune system recognize and attack cancer cells by blocking a protein called PD‑1. The trial tests how it fits into treatment sequences for lung cancer.

  • Atezolizumab

    is an IV immunotherapy that blocks the PD‑L1 protein, allowing the immune system to fight the tumor. Its position in the treatment order is being examined in the study.

  • Lorlatinib

    is an oral drug that blocks several abnormal proteins (including ALK and ROS1) that drive tumor growth. The study assesses its effectiveness when used early or later in therapy.

What is already known about the treatment

  • Lazertinib

    This drug is taken by mouth as a film‑coated tablet. It is an approved targeted therapy for certain types of non‑small cell lung cancer and is described in many clinical studies. Lazertinib blocks the activity of the mutant EGFR protein that drives tumor growth. It belongs to the class of EGFR tyrosine‑kinase inhibitors.

  • Dabrafenib

    Dabrafenib is an oral capsule that patients swallow. It is an approved treatment for cancers with a BRAF V600 mutation and is widely studied in the literature. The medicine blocks the mutated BRAF protein, stopping signals that tell cancer cells to multiply. It is classified as a BRAF inhibitor.

  • Vinorelbine

    Vinorelbine is given by intravenous infusion of a solution. It is a chemotherapy drug that has been used for many years in lung cancer and is well documented in medical texts. It works by interfering with the formation of microtubules, which are needed for cancer cells to divide. It belongs to the class of vinca alkaloid antineoplastics.

  • Nivolumab

    Nivolumab is administered as an intravenous infusion of a sterile solution. It is an approved immune‑checkpoint inhibitor used for several cancers, including lung cancer, and is supported by extensive clinical research. The antibody blocks the PD‑1 protein on immune cells, helping the body’s own defenses attack the tumor. It is classified as a PD‑1 inhibitor.

  • Atezolizumab

    Atezolizumab is given by intravenous infusion of a solution. It is an approved immunotherapy for lung cancer and other tumors and has a strong evidence base in many trials. It binds to the PD‑L1 protein, preventing it from turning off immune cells that can kill cancer. It is a PD‑L1 inhibitor.

  • Lorlatinib

    Lorlatinib is taken orally as a film‑coated tablet. It is an approved drug for ALK‑positive lung cancer and is well described in recent studies. The medicine blocks the ALK and ROS1 proteins that drive tumor growth. It belongs to the class of ALK/ROS1 tyrosine‑kinase inhibitors.

Investigated diseases

Non‑small cell lung cancer - Non‑small cell lung cancer (NSCLC) is a cancer that starts in the lining of the larger airways of the lungs. It grows as a solid tumor that can invade nearby lung tissue and the chest wall. Over time the tumor may spread through the lymphatic system to nearby lymph nodes and later to distant organs such as the brain, liver, or bones. The disease often develops gradually, with symptoms appearing as the tumor enlarges and spreads.
Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2026-525268-16-00Protocol codeDynamicEstimated enrolment962 patientsSponsorUniversita' Degli Studi Di Torino

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