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Study on Chemotherapy with Paclitaxel, Cisplatin, and Carboplatin for Patients with Resected Stage I or IIA Non-Squamous 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 a type of lung cancer known as non-squamous non-small cell lung cancer (NSCLC) that has been completely removed through surgery. The study involves patients with early stages of this cancer, specifically stage I or IIA, who are identified as having a high or intermediate risk of cancer returning. The purpose of the study is to explore the benefits of using additional treatment, called adjuvant chemotherapy, after surgery to help prevent the cancer from coming back. This treatment involves using a combination of medications, including Paclitaxel, Cisplatin, Carboplatin, Vinorelbine Tartrate, Docetaxel, and Pemetrexed, which are administered through an intravenous infusion, meaning they are given directly into a vein.

The study is designed to compare two groups of patients: those who receive the chemotherapy treatment and those who do not, to see if the treatment helps in extending the time patients remain free from cancer. The chemotherapy treatment is given in cycles, with each cycle lasting a few weeks, and the total treatment period can last up to 16 weeks. The study aims to personalize patient care by using a special test called the 14-Gene Prognostic Assay, which helps determine the risk level of cancer returning based on the genetic makeup of the tumor.

Participants in the study will be monitored over time to track their health and any signs of cancer returning. The study will help researchers understand if using chemotherapy after surgery can improve outcomes for patients with high or intermediate risk of cancer recurrence. This information could lead to better treatment strategies for patients with early-stage non-squamous NSCLC in the future.

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

    Randomization

    Upon joining the study, the patient is randomly assigned to one of two groups: observation or adjuvant chemotherapy. This randomization is based on the results of a 14-gene prognostic test, which assesses the risk level of the patient's cancer.

  2. Step 2

    Chemotherapy administration

    If assigned to the chemotherapy group, the patient receives four cycles of a standard treatment for non-small cell lung cancer. This treatment involves a combination of medications administered through an intravenous infusion.

    The medications used may include paclitaxel, cisplatin, carboplatin, vinorelbine tartrate, docetaxel, and pemetrexed. The specific combination and dosage depend on the patient's individual treatment plan.

  3. Step 3

    Follow-up

    After completing the chemotherapy cycles, the patient enters a follow-up phase. This phase involves regular monitoring to assess the duration of disease-free survival (DFS), which is the time from randomization to any recurrence of the disease or death from any cause.

    The follow-up period is expected to last up to five years from the start of the study. During this time, the patient's health and any potential recurrence of cancer are closely monitored.

  4. Step 4

    Data analysis

    Throughout the trial, data is collected to evaluate the effectiveness of the treatment. The primary focus is on the duration of DFS in patients identified as high or intermediate risk by the 14-gene prognostic assay.

    Secondary analyses include overall survival (OS) and time to recurrence (TTR), which help to further understand the benefits of personalized treatment based on molecular data.

Who can join the trial?

11 criteria

  • The patient must have signed a written consent form approved by the appropriate authorities before any study-related procedures that are not part of regular care.
  • Men must agree to use two reliable methods of contraception with female partners, practice true abstinence, or have sexual relationships only with male partners or sterile female partners during and for 6 months after chemotherapy.
  • The patient should have national health insurance coverage (only for patients in France).
  • The patient must be 18 years or older.
  • The patient must be able to follow the study protocol, including being a suitable candidate for additional chemotherapy and likely to comply with follow-up for 5 years.
  • The patient must be willing to be randomly assigned to receive chemotherapy.
  • The patient must have a completely removed (R0) Stage I or IIA non-squamous non-small cell lung cancer, as confirmed by a tissue examination. This means the cancer has been surgically removed, and the tissue has been checked under a microscope. Certain types of lung cancer are eligible, and specific surgical procedures are required.
  • A sufficient tissue sample must be available for a specific test called the 14-Gene Prognostic Assay.
  • The patient must have a life expectancy of at least 5 years, not considering the lung cancer diagnosis.
  • The patient must have an ECOG performance status of 0-1, which means they are fully active or have some symptoms but do not need bed rest during the day.
  • Women who can have children must practice true abstinence, have sexual relationships only with female partners or sterile male partners, or use reliable contraception methods. They must have a negative pregnancy test before the study and agree to use contraception during the study and for 6 months after the last study medication.

Who cannot join the trial?

8 criteria

  • Patients who have not had their lung cancer completely removed through surgery.
  • Patients with lung cancer that is not classified as stage I or IIA.
  • Patients with a type of lung cancer called **squamous** non-small cell lung cancer.
  • Patients who are not at **High or Intermediate Risk** according to a specific test called the 14-Gene Prognostic Assay.
  • Patients who are not willing to start additional treatment after surgery, which involves four cycles of a standard lung cancer treatment using **platinum-based** drugs.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial groups.
  • Patients who are considered part of a **vulnerable population**, which means they might need special protection or care.
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Investigated drugs

Platinum-Based Doublet Chemotherapy is a standard treatment for non-small cell lung cancer (NSCLC). It involves using two chemotherapy drugs, one of which is a platinum compound. This combination is used to kill cancer cells and prevent them from growing and dividing. In this trial, patients with completely resected stage I or IIA non-squamous NSCLC, identified as high or intermediate risk, may receive this therapy to see if it improves their disease-free survival.

What is already known about the treatment

Cisplatin – Cisplatin is administered intravenously and is commonly used in combination with other chemotherapy drugs. It is currently well-established in medical literature as a standard treatment for various types of cancer, including non-small cell lung cancer (NSCLC). The main therapeutic indication for cisplatin is to treat completely resected stage I or IIA non-squamous NSCLC, especially in patients identified as high or intermediate risk by a 14-gene prognostic assay. At the molecular level, cisplatin works by binding to DNA in cancer cells, causing cross-linking and ultimately leading to cell death. It is classified as a platinum-based chemotherapy agent.

Investigated diseases

Non-Squamous Non-Small Cell Lung Cancer (NSCLC) – This type of lung cancer is characterized by the presence of cancerous cells in the lung tissue that are not of the squamous cell type. It is a common form of lung cancer, distinct from small cell lung cancer, and includes subtypes such as adenocarcinoma and large cell carcinoma. In its early stages, specifically stage I or IIA, the cancer is localized and may be completely resected, meaning it can be surgically removed. The progression of the disease can vary, with some patients experiencing recurrence after initial treatment. The risk of recurrence can be assessed using molecular prognostic data, which helps in personalizing patient care.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511185-37-00Protocol codeEC-120888Estimated enrolment915 patientsSponsorIntergroupe Francophone De Cancerologie Thoracique

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