Ongoing Clinical Trials for Small Cell Lung Cancer Limited Stage
This article provides information about 5 ongoing clinical trials for patients with limited-stage small cell lung cancer. These studies are testing different immunotherapy and targeted therapy medications given after or alongside standard chemotherapy and radiation treatment. The trials are taking place across multiple European countries and aim to improve survival and prevent cancer from returning or worsening.
Clinical trial locations
- Belgium
- Bulgaria
- Estonia
- France
- Durvalumab Maintenance Therapy for Frail Patients with Limited Stage Small Cell Lung Cancer After Chemoradiotherapy
- Study of Pembrolizumab and Olaparib with Chemoradiation for Patients with Newly Diagnosed Limited-Stage Small Cell Lung Cancer
- Study on Toripalimab and Tifcemalimab for Patients with Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy
- Germany
- Greece
- Hungary
- Italy
- Lithuania
- Netherlands
- Poland
- Portugal
- Romania
- Spain
- Study of Pembrolizumab and Olaparib with Chemoradiation for Patients with Newly Diagnosed Limited-Stage Small Cell Lung Cancer
- Study of Tarlatamab maintenance treatment after chemotherapy and radiation therapy in patients with limited stage small cell lung cancer who cannot receive both treatments together
- Study on Toripalimab and Tifcemalimab for Patients with Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy
Durvalumab Maintenance Therapy for Frail Patients with Limited Stage Small Cell Lung Cancer After Chemoradiotherapy
This trial, conducted in France, focuses on patients who are considered frail and have completed chemotherapy and radiation treatment for their cancer. The study evaluates whether continuing treatment with durvalumab, an immunotherapy medication, can help keep the cancer from returning or getting worse.
Who can join: Patients must be at least 18 years old with confirmed diagnosis of limited-stage disease. They must have completed thoracic chemoradiotherapy including at least 60 Gy of radiation with either cisplatin-etoposide or carboplatin-etoposide chemotherapy. Patients should have disease control shown on scans and must weigh more than 30 kg. They need adequate blood cell counts, kidney function, and liver function. Women who can become pregnant must use effective birth control and have a negative pregnancy test.
Who cannot join: Patients who have already received treatment for their limited-stage disease, those who are not considered frail, and those who have received simultaneous chemotherapy and radiation therapy are excluded. Patients with certain other health conditions may also be excluded.
What the trial tests: The study examines whether durvalumab maintenance therapy can extend the time patients live without their cancer worsening, known as progression-free survival. It also looks at overall survival, quality of life, and any side effects from the treatment.
Investigational drug: Durvalumab is an immunotherapy drug given by intravenous infusion. It works by blocking a protein called PD-L1, which helps cancer cells hide from the immune system, allowing the body to better fight the cancer. Treatment can continue for up to 24 months.
Study on Toripalimab and Tifcemalimab for Patients with Limited-Stage Small Cell Lung Cancer After Chemoradiotherapy
This international trial spans Belgium, Poland, Germany, Romania, Italy, Spain, France, and the Netherlands. It studies whether adding immunotherapy medications after standard chemotherapy and radiation can prevent cancer from returning.
Who can join: Patients must be at least 18 years old with confirmed limited-stage disease. They must have completed 4 cycles of chemotherapy with carboplatin or cisplatin and etoposide, plus a certain amount of radiation. The cancer must have responded to treatment or remained stable without progression. Patients must start the study treatment within 42 days of finishing chemoradiotherapy. They need an ECOG performance status score of 0-1, meaning they can perform daily activities with little difficulty. Adequate organ function and a life expectancy of at least 12 weeks are required.
Who cannot join: Patients who haven’t completed chemoradiotherapy, those whose cancer has worsened after treatment, those outside the age range, pregnant or breastfeeding women, and those with allergies to the study medications are excluded. Patients who participated in another recent clinical trial or have certain infections or diseases affecting the immune system cannot join.
What the trial tests: The study evaluates whether toripalimab alone or combined with tifcemalimab can improve survival rates and delay cancer progression compared to placebo. Participants receive either toripalimab alone, toripalimab with tifcemalimab, or placebo through intravenous infusion.
Investigational drugs: Toripalimab and tifcemalimab are immunotherapy medications that help the immune system recognize and attack cancer cells. Toripalimab blocks the PD-1 pathway, while tifcemalimab targets other immune pathways to boost the body’s natural defenses against tumors.
Study of Tarlatamab maintenance treatment after chemotherapy and radiation therapy in patients with limited stage small cell lung cancer who cannot receive both treatments together
This trial in Spain focuses on patients who received chemotherapy and radiation therapy separately rather than at the same time. It tests whether maintenance treatment with tarlatamab can prevent cancer from returning.
Who can join: Patients must be at least 18 years old with confirmed diagnosis through tissue examination. They must have completed chemotherapy alone or chemotherapy followed by radiation therapy, with no signs of cancer progression. Patients need adequate organ function, normal heart function with ejection fraction of 50% or higher, and oxygen levels above 90% when breathing room air. They should have an ECOG performance status of 0-2 and a life expectancy of at least 3 months. At least one measurable tumor must be present.
Who cannot join: Patients under 18, those with active brain metastases, recent history of another cancer within the last 3 years, severe heart conditions, uncontrolled high blood pressure, recent heart attack, active infections, HIV, active hepatitis B or C, pregnant or breastfeeding women, and those with allergies to the study medication are excluded. Patients who had major surgery within 4 weeks before starting the study cannot participate.
What the trial tests: The study determines whether tarlatamab maintenance treatment after sequential chemotherapy and radiation can extend progression-free survival and overall survival compared to standard follow-up care alone.
Investigational drug: Tarlatamab is a novel bispecific antibody therapy given intravenously. It simultaneously targets DLL3 (found on cancer cells) and CD3 (found on immune T-cells), helping the patient’s immune system attack cancer cells. The maximum daily dose is 10 milligrams, and treatment may continue for up to 24 months.
Study of Pembrolizumab and Olaparib with Chemoradiation for Patients with Newly Diagnosed Limited-Stage Small Cell Lung Cancer
This multi-country trial spans Lithuania, Romania, Greece, Bulgaria, France, Hungary, Italy, Spain, Belgium, Portugal, and Estonia. It studies whether adding immunotherapy and targeted therapy to standard treatment can improve outcomes for newly diagnosed patients.
Who can join: Patients must be at least 18 years old with confirmed diagnosis through cell or tissue examination. They must have limited-stage disease that can be treated with radiation, with no previous treatment for their cancer. Patients need adequate organ function, an ECOG performance status of 0 or 1, and at least one measurable tumor. A life expectancy of at least 6 months is required. Patients of childbearing potential must use effective birth control during the study.
Who cannot join: Patients who have received any previous treatment for their cancer, those with other serious health conditions that might interfere with the study, pregnant or breastfeeding women, and those already participating in another clinical trial are excluded. Patients unable to follow study procedures or attend required visits cannot join.
What the trial tests: The study evaluates whether adding pembrolizumab (an immunotherapy drug) and olaparib (a targeted therapy drug) to standard chemoradiation can improve survival and response rates. Participants receive either the combination treatment or chemoradiation alone.
Investigational drugs: Pembrolizumab is given intravenously every three weeks and works by blocking a protein on cancer cells, allowing the immune system to better attack them. Olaparib is taken orally twice daily and interferes with cancer cells’ ability to repair themselves. The trial also includes standard chemoradiation with etoposide and carboplatin.
Study on the Effectiveness and Safety of Cisplatin, Carboplatin, Etoposide, and Durvalumab in Patients with Limited Stage Small Cell Lung Cancer
This trial in Germany tests whether adding durvalumab immunotherapy to standard chemotherapy and radiotherapy can improve outcomes.
Who can join: Patients must be at least 18 years old with confirmed diagnosis of limited disease. They must weigh more than 30 kg and have an ECOG performance status score of 0-1. At least one measurable tumor must be present. Patients need adequate organ function including hemoglobin of at least 9.0 g/dL, sufficient white blood cells and platelets, normal liver enzyme levels, and adequate kidney function. A life expectancy of at least 12 weeks is required. Tumor tissue must be available for research testing.
Who cannot join: Patients with other types of cancer besides limited-stage disease, those who have received previous chemotherapy or radiation for their cancer, those with serious health conditions that could interfere with the study, pregnant or breastfeeding women, and those unable to follow study procedures are excluded. Patients participating in another clinical trial simultaneously cannot join.
What the trial tests: The study determines if adding durvalumab to standard chemotherapy (cisplatin or carboplatin with etoposide) and radiotherapy can improve progression-free survival at 18 months. It also assesses overall survival, response rates, quality of life, and safety.
Investigational drugs: Durvalumab is an immunotherapy drug given intravenously that helps the immune system fight cancer by blocking the PD-L1 protein. It is combined with standard chemotherapy drugs cisplatin, carboplatin, and etoposide, which work by damaging cancer cell DNA to prevent them from growing. Radiotherapy uses high-energy rays to kill cancer cells.
Summary
All five trials focus on improving treatment outcomes for patients with limited-stage small cell lung cancer through various approaches. Three trials test immunotherapy as maintenance treatment after completing initial chemotherapy and radiation, while two trials evaluate adding immunotherapy alongside standard treatment from the beginning.
The most widely tested medication across these trials is durvalumab, featured in two separate studies. Other immunotherapy drugs being investigated include pembrolizumab, toripalimab, tifcemalimab, and tarlatamab. Several trials also explore combination approaches, pairing immunotherapies with each other or with targeted therapies like olaparib.
The trials are concentrated in Western European countries, with Spain, France, and multiple countries in Eastern and Southern Europe represented. The study designs vary to accommodate different patient populations, including frail patients, those unable to receive simultaneous chemotherapy and radiation, and newly diagnosed patients who haven’t received any prior treatment.
These clinical trials represent important research efforts to find more effective treatments that can help patients live longer without their cancer progressing, while maintaining quality of life and managing side effects. Patients interested in participating should discuss eligibility requirements and potential risks and benefits with their healthcare providers.
