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Non-small cell lung cancer stage I – Trials in Disease

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Ongoing Clinical Trials for Stage I Non-Small Cell Lung Cancer

There are currently 4 ongoing clinical trials investigating new treatments for Stage I Non-Small Cell Lung Cancer. These studies are testing innovative combinations of chemotherapy, immunotherapy, and targeted radiation therapies aimed at preventing cancer recurrence and improving survival outcomes for patients with early-stage lung cancer.

Clinical trial locations

Study on Datopotamab Deruxtecan and Rilvegostomig for Stage I Non-Small Cell Lung Cancer Patients with ctDNA-Positive or High-Risk Features

This trial is designed for patients with Stage I adenocarcinoma who have undergone complete surgical removal of their tumor but show signs of circulating tumor DNA in their blood or have high-risk features that increase the chance of cancer returning. The study tests a novel combination of two medications: Datopotamab deruxtecan and Rilvegostomig.

Inclusion criteria: Participants must have confirmed Stage I adenocarcinoma that has been completely removed through surgery, with no signs of cancer on post-surgical scans. They must either test positive for circulating tumor DNA before surgery or have high-risk features such as visceral pleural invasion, lymphovascular invasion, or high-grade tumor cells. Patients need to have good overall health status and adequate organ function, with life expectancy exceeding 6 months.

Exclusion criteria: Patients with cancer types other than Stage I adenocarcinoma, those without ctDNA-positive results or high-risk features, and those who have not had complete tumor removal are not eligible. Pregnant or breastfeeding women, patients with serious health conditions that could interfere with the study, and those participating in other trials are also excluded.

Study focus: The main goal is to determine whether the combination of Datopotamab deruxtecan and Rilvegostomig works better than standard treatments in preventing cancer recurrence. Participants will be randomly assigned to receive either the new combination treatment, Rilvegostomig alone, or standard care. The trial will monitor disease-free survival, overall survival, and quality of life.

Investigational drugs: Datopotamab deruxtecan is an antibody-drug conjugate that delivers chemotherapy directly to cancer cells, potentially reducing harm to healthy cells. Rilvegostomig is a monoclonal antibody designed to help the immune system recognize and attack cancer cells more effectively.

Study on Atezolizumab, Carboplatin, and Etoposide for Adults with Advanced Large-Cell Neuroendocrine Lung Cancer

This trial focuses on large-cell neuroendocrine carcinoma, a rare and aggressive form of lung cancer. The study tests a combination of Atezolizumab, an immunotherapy drug, with standard chemotherapy drugs Carboplatin or Cisplatin and Etoposide.

Inclusion criteria: Participants must have a confirmed diagnosis of locally advanced or metastatic large-cell neuroendocrine carcinoma without curative treatment options. They should not have received previous systemic therapy, unless it was curative treatment that ended at least 6 months before cancer recurrence. Patients must plan to receive treatment with platinum-based chemotherapy and Etoposide, have an ECOG performance status of 0 to 2, be at least 18 years old, and have adequate organ function including appropriate liver enzyme levels, bilirubin, creatinine, neutrophil, and platelet counts.

Exclusion criteria: Patients who have received cancer treatment within the last 4 weeks, have severe allergic reactions to study drugs, active infections requiring treatment, other serious medical conditions, are pregnant or breastfeeding, or participated in another clinical trial within the last 4 weeks cannot participate. Those with brain metastases, autoimmune diseases, or a history of drug or alcohol abuse within the last 12 months are also excluded.

Study focus: The trial aims to evaluate how well Atezolizumab combined with standard chemotherapy improves survival in patients with this aggressive form of lung cancer. Researchers will monitor treatment response, cancer changes, and side effects throughout the study.

Investigational drugs: Atezolizumab is an immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells. Platinum-based drugs like Carboplatin or Cisplatin damage cancer cell DNA to stop their growth, while Etoposide interferes with cell division.

Study on Chemotherapy with Paclitaxel, Cisplatin, and Carboplatin for Patients with Resected Stage I or IIA Non-Squamous Non-Small Cell Lung Cancer

This trial investigates the benefit of additional chemotherapy after surgery for patients with non-squamous lung cancer at high or intermediate risk of recurrence. The study uses a special genetic test called the 14-Gene Prognostic Assay to determine which patients might benefit from additional treatment.

Inclusion criteria: Patients must have completely removed Stage I or IIA non-squamous cancer, be 18 years or older, and have adequate tissue available for the genetic test. They need to have a life expectancy of at least 5 years, ECOG performance status of 0-1, and be willing to undergo randomization. Men and women of childbearing potential must use reliable contraception methods.

Exclusion criteria: Patients with incompletely removed cancer, squamous cell type, those not at high or intermediate risk according to the genetic test, or those unwilling to receive four cycles of platinum-based chemotherapy are excluded. Vulnerable populations requiring special protection are also not eligible.

Study focus: The trial compares patients receiving adjuvant chemotherapy to those under observation alone, aiming to determine if chemotherapy extends disease-free survival in patients identified as high or intermediate risk by genetic testing. This personalized approach could lead to better treatment strategies.

Investigational drugs: The study uses platinum-based doublet chemotherapy, which combines two drugs including a platinum compound. These medications work together to kill cancer cells and prevent their growth and division after surgical removal.

Study on the Safety and Effectiveness of Stereotactic Body Radiotherapy with or without Pembrolizumab for Patients with Unresected Stage I or II Non-Small Cell Lung Cancer

This trial is for patients with early-stage lung cancer who cannot undergo surgery. It tests whether adding Pembrolizumab, an immunotherapy drug, to Stereotactic Body Radiotherapy (a precise form of radiation therapy) improves outcomes compared to radiation alone.

Inclusion criteria: Participants must have previously untreated Stage I or II lung cancer confirmed by CT and PET scans. They cannot have thoracic surgery due to medical conditions, or they have chosen SBRT over surgery with clear documentation of this decision. Patients must have an ECOG Performance Status of 0-2, be able to receive SBRT without ultra-central tumor location, and have adequate organ function. Women must not be pregnant or breastfeeding and must use effective contraception.

Exclusion criteria: Patients with unresected Stage I or II cancer who fall outside the specified age range, belong to excluded clinical trial groups, or are part of vulnerable populations requiring special care cannot participate.

Study focus: The trial evaluates whether adding Pembrolizumab to SBRT can improve event-free survival, meaning the time patients remain free from cancer progression or recurrence. Researchers will also assess overall survival rates, quality of life, and treatment side effects.

Investigational drugs: Pembrolizumab is an immune checkpoint inhibitor that blocks the PD-1 protein on immune cells, helping them recognize and attack cancer cells more effectively. SBRT delivers high-precision radiation doses to tumors while minimizing damage to surrounding healthy tissue.

Summary

The four ongoing clinical trials for Stage I lung cancer reflect different clinical scenarios and treatment approaches. Three trials focus on patients who have undergone surgical removal of their tumors, exploring whether additional treatments can prevent recurrence. One trial addresses patients who cannot have surgery, testing precision radiation therapy with or without immunotherapy.

Germany and France are particularly active in this research, with Germany participating in all four trials and France in three. The trials span a total of 12 European countries, demonstrating strong international collaboration in advancing treatment options for early-stage lung cancer.

Several innovative approaches are being tested, including the use of genetic testing to personalize treatment decisions, novel antibody-drug conjugates that target cancer cells more precisely, and combinations of immunotherapy with chemotherapy or radiation. These studies aim to improve outcomes for patients with early-stage disease, when treatment has the greatest potential to prevent cancer from returning or progressing.

Ongoing Clinical Trials on Non-small cell lung cancer stage I

  • Study on Datopotamab Deruxtecan and Rilvegostomig for Stage I Non-Small Cell Lung Cancer Patients with ctDNA-Positive or High-Risk Features

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Hungary Italy The Netherlands +3

  • Study on the Effectiveness and Safety of Osimertinib for Patients with Stage IB-IIIA Non-Small Cell Lung Cancer After Tumor Removal

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy Poland Spain +1

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