Large cell lung cancer – Trials in Disease

Go back

Clinical Trials for Large Cell Lung Cancer: Current Research Studies

There are currently 3 ongoing clinical trials investigating new treatments for large cell lung cancer. These studies are taking place across multiple European countries including Germany, Hungary, Czechia, France, and Spain. The trials focus on immunotherapy combinations, diagnostic testing methods, and personalized cell therapy approaches for patients with advanced disease.

Clinical trial locations

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

This trial is taking place in Germany and focuses on a specific aggressive form of the disease called large-cell neuroendocrine carcinoma. The study combines immunotherapy with standard chemotherapy to see if this approach can improve patient survival.

Main inclusion criteria:

  • Adults aged 18 years or older
  • Diagnosis of locally advanced or metastatic large-cell neuroendocrine carcinoma with no curative treatment options available
  • No previous systemic therapy, though patients who received curative treatment and had cancer return at least 6 months later may participate
  • Good functional status, able to perform daily activities with an ECOG performance score of 0 to 2
  • Measurable disease according to standard cancer measurement criteria
  • Adequate organ function including liver, kidney, and blood cell counts

Main exclusion criteria:

  • Recent cancer treatment within the last 4 weeks
  • History of severe allergic reactions to the study medications
  • Active infections requiring treatment
  • Pregnancy or breastfeeding
  • Brain metastases unless previously treated and stable
  • Unstable autoimmune diseases
  • Recent history of drug or alcohol abuse
  • Other serious medical conditions that could interfere with the study

Focus and goal: The trial evaluates whether adding atezolizumab, an immunotherapy drug that helps the immune system recognize and fight cancer cells, to standard platinum-based chemotherapy with carboplatin or cisplatin and etoposide can improve survival outcomes. Patients receive treatment in cycles through intravenous infusion, and researchers monitor how the cancer responds, track survival times, and assess any side effects.

Investigational drugs: The study uses atezolizumab combined with platinum-based chemotherapy drugs (carboplatin or cisplatin) and etoposide. Atezolizumab is an immunotherapy that blocks a protein helping cancer cells hide from the immune system. The platinum drugs and etoposide are chemotherapy medications that damage cancer cell DNA to stop them from growing and dividing.

Study on the Accuracy of OWL-EVO1 Test for Diagnosing Lung Cancer in Patients Eligible for Screening or with Suspicious CT Findings

This diagnostic study is being conducted in Hungary and Czechia and focuses on testing a new breath-based method for detecting the disease. The OWL-EVO1 Breath Biopsy test aims to provide a non-invasive way to identify cancer in people undergoing screening or those with suspicious CT scan findings.

Main inclusion criteria:

  • Between 45 and 85 years old
  • Able to understand the study and provide informed consent
  • Body mass index between 16 and less than 40
  • Have had a CT scan of the chest area within the last 6 months

Main exclusion criteria:

  • Not eligible for standard screening based on low dose CT scans
  • No suspicious findings on CT scan that could indicate cancer
  • Clinical presentations where cancer is not part of the possible diagnosis

Focus and goal: The trial assesses how accurately the OWL-EVO1 breath test can identify cancer compared to other conditions that might look similar on imaging scans. Participants receive a special solution through intravenous infusion, then breath samples are collected at various time points. Researchers evaluate whether this test can reliably detect cancer, potentially leading to earlier and more accurate diagnosis. The study also monitors the safety and tolerability of the test.

Investigational tool: OWL-EVO1 is a diagnostic test that analyzes breath samples to detect specific markers that may indicate the presence of cancer. It works by identifying volatile organic compounds in the breath that can signal disease. This non-invasive approach could offer a simpler alternative to more invasive diagnostic procedures.

Study on the Safety and Effects of ATL001 and Pembrolizumab in Adults with Advanced Non-Small Cell Lung Cancer

This innovative trial is being conducted across France, Spain, and Germany and explores personalized cell therapy for patients with advanced non-small cell lung cancer, which includes large cell carcinoma as one of its subtypes. The study investigates ATL001, a specialized immune cell therapy, both alone and in combination with pembrolizumab.

Main inclusion criteria:

  • Between 18 and 75 years old
  • Life expectancy of at least 6 months
  • Advanced disease that cannot be surgically removed or has spread, with progression after standard treatments or inability to receive standard treatments
  • Good performance status (ECOG 0-1), meaning able to carry out normal activities with minimal restrictions
  • Previous treatment with PD-1/PD-L1 inhibitor immunotherapy with either disease progression or stable disease after at least four doses
  • Measurable disease according to medical guidelines
  • Accessible tumor sites suitable for tissue collection
  • Adequate organ function based on blood test results
  • Agreement to use effective birth control for specified periods

Main exclusion criteria:

  • Other cancer types besides non-small cell lung cancer
  • Inability to follow study procedures
  • Certain medical conditions that might interfere with the study
  • Medications that could interact with study treatments
  • Pregnancy or breastfeeding
  • Recent participation in another clinical trial
  • History of allergic reactions to study drugs

Focus and goal: The trial evaluates the safety and effectiveness of ATL001, a personalized therapy using specially designed immune T cells that recognize and attack cancer cells. The study examines this treatment alone and combined with pembrolizumab, an approved immunotherapy. The process involves collecting tumor tissue to manufacture the personalized therapy, preparing the body through lymphodepletion medications (fludarabine and cyclophosphamide), then administering ATL001 through infusion. Researchers monitor how tumors respond and track patient outcomes over time.

Investigational drugs: ATL001 is a personalized T cell therapy created from the patient’s own immune cells, modified to target specific proteins on cancer cells. Pembrolizumab is an established immunotherapy that blocks the PD-1 protein, helping the immune system attack cancer cells more effectively. The combination aims to enhance the body’s natural defense mechanisms against cancer.

Summary

The three ongoing clinical trials for large cell lung cancer represent diverse approaches to improving diagnosis and treatment. Two trials focus on advanced disease treatment using immunotherapy approaches, while one investigates a novel diagnostic method.

Geographically, these studies span five European countries, with Germany participating in two trials, demonstrating a concentration of research activity in Central Europe. The trials also show geographic collaboration, with the diagnostic study operating across two countries and the personalized therapy trial spanning three nations.

Treatment approaches vary significantly among these studies. The German trial focuses on combining established immunotherapy with standard chemotherapy for large-cell neuroendocrine carcinoma. The multi-country personalized therapy trial represents cutting-edge research using modified immune cells tailored to individual patients. The diagnostic trial takes a completely different approach, aiming to improve early detection through breath analysis rather than treating established disease.

All three trials require careful patient selection based on specific medical criteria including age, disease stage, previous treatments, and overall health status. Patients interested in participating should discuss eligibility with their healthcare providers, as each study has distinct requirements that may make one more suitable than another depending on individual circumstances.

Ongoing Clinical Trials on Large cell lung cancer

  • Study on the Safety and Effects of ATL001 and Pembrolizumab in Adults with Advanced Non-Small Cell Lung Cancer

    Not recruiting

    1 1 1
    Investigated drugs:
    France Germany Spain
  • Study on the Accuracy of OWL-EVO1 Test for Diagnosing Lung Cancer in Patients Eligible for Screening or with Suspicious CT Findings

    Not recruiting

    1 1
    Investigated drugs:
    Czechia Hungary