Clinical Trials for Small Cell Lung Cancer: Current Research and Treatment Options

This article provides comprehensive information about 34 ongoing clinical trials investigating new treatments for small cell lung cancer, a fast-growing type of lung cancer. These studies are taking place across multiple countries and are testing various medications including immunotherapies, chemotherapy combinations, and targeted therapies to improve survival and quality of life for patients with this challenging disease.

Clinical trial locations

Study of Atezolizumab and Chemotherapy for Patients with Relapsed Small Cell Lung Cancer

This clinical trial focuses on treating patients whose small cell lung cancer has returned after initial therapy. To be eligible, participants must have received previous treatment with chemotherapy and a PD-L1 inhibitor, and their cancer must have progressed afterward. The cancer should be confirmed through biopsy, and patients need to have adequate organ function and a good performance status (ECOG 0-1). Participants must also meet specific criteria for blood counts, liver function, and kidney function.

The trial excludes patients with certain medical conditions or those who are pregnant or breastfeeding. Participants cannot have other types of cancer besides SCLC, nor can they be taking medications that interfere with the study treatment.

The main goal of this research is to evaluate whether combining atezolizumab with standard chemotherapy can improve survival compared to chemotherapy alone. Atezolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells by blocking the PD-L1 protein. The chemotherapy used in this study is platinum-etoposide, a standard treatment regimen for SCLC.

Throughout the study, researchers will monitor overall survival, progression-free survival (how long patients live without cancer getting worse), and the overall response rate (how well tumors shrink). Safety will also be carefully tracked to identify any side effects from the treatment combination.

Study of BT-001 and Pembrolizumab for Patients with Advanced Solid Tumors, Including Sarcoma, Merkel Cell Carcinoma, Melanoma, Breast, and Lung Cancer

This trial investigates a novel treatment approach for various advanced cancers, including small cell lung cancer and non-small cell lung cancer. The study tests BT-001, an experimental treatment injected directly into tumors, either alone or combined with pembrolizumab, an established immunotherapy medication.

To participate, patients must be at least 18 years old and have received complete COVID-19 vaccination at least 30 days before treatment begins. They must have tried standard treatments without success or be unable to tolerate them. The trial requires at least one tumor that can be easily injected, located on the skin, under the skin, or in a lymph node. Participants need adequate organ function and a life expectancy of at least three months.

The study excludes patients with uncontrolled brain metastases, active infections, severe medical conditions, or those who are pregnant or breastfeeding. Participants cannot have severe allergies to study medications or be enrolled in other clinical trials simultaneously.

BT-001 is injected directly into tumors to stimulate the immune system to attack cancer cells. Pembrolizumab is given through intravenous infusion and works by blocking a protein that prevents immune cells from attacking cancer. The combination aims to enhance the body’s natural cancer-fighting abilities. Researchers will monitor treatment safety, effectiveness, and how long patients respond to the therapy.

Study of Durvalumab for Patients with Limited Stage Small Cell Lung Cancer After Chemoradiotherapy

This Spanish trial examines durvalumab as a consolidation treatment for patients with limited stage small cell lung cancer who have completed chemoradiotherapy without disease progression. The study aims to describe the safety profile of durvalumab and monitor how long patients remain without disease progression.

Eligible participants must be at least 18 years old with a performance status of 0, 1, or 2, indicating they can perform daily activities with minimal to moderate limitations. They must have completed chemotherapy with platinum and etoposide, along with appropriate radiation therapy, within 1 to 90 days before starting durvalumab. Their cancer must have responded to or remained stable after chemoradiotherapy.

Patients are excluded if they have untreated or active brain metastases, autoimmune diseases requiring systemic treatment in the past two years, organ transplant history, active infections, or significant heart conditions. Pregnant or breastfeeding women cannot participate, nor can those who have received live vaccines within 30 days before the study.

Durvalumab is an immune checkpoint inhibitor that helps the immune system better recognize and attack cancer cells by blocking the PD-L1 protein. The medication is given through intravenous infusion every 2 or 4 weeks. Throughout the study, participants will be closely monitored for side effects, particularly immune-related adverse events, and their disease status will be regularly assessed. The trial will help determine if durvalumab can maintain the benefits achieved from chemoradiotherapy and prevent cancer recurrence.

Study of Tarlatamab for Patients with Metastatic or Advanced Small-Cell Lung Cancer and Neuroendocrine Carcinomas

This French trial investigates tarlatamab (AMG 757) for treating metastatic small-cell lung cancer and other poorly differentiated neuroendocrine carcinomas. The study focuses on patients whose cancer has progressed after at least one previous therapy, including platinum-based treatment.

Participants must be at least 18 years old with an ECOG performance status of 0-2, meaning they can perform most daily activities with some limitations. They need a life expectancy of at least three months and must have at least one measurable tumor. The trial requires adequate bone marrow reserve and organ function, confirmed through laboratory tests. An oxygen saturation level greater than 90% on room air is required. Female participants must have a negative pregnancy test and agree to use effective birth control during the study and for at least 60 days afterward.

The study excludes patients with other cancer types not specified, those outside the required age range, and vulnerable populations needing special protection. Participants must be able to provide informed consent and comply with study procedures.

Tarlatamab is a bispecific T-cell engager that helps the immune system target and fight cancer cells. It is administered through intravenous infusion. Throughout the trial, researchers will monitor treatment effectiveness through tumor and blood biopsies taken before, during, and after treatment. These samples help analyze how the cancer responds or develops resistance to the medication. The study aims to determine if tarlatamab can provide a new treatment option for patients with these difficult-to-treat cancers.

Study on MK-6070 and Ifinatamab Deruxtecan for Patients with Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer

This Spanish trial evaluates two investigational medications for patients with extensive-stage small cell lung cancer that has returned or worsened after previous treatment. The study examines MK-6070 and ifinatamab deruxtecan (I-DXd), both alone and in combination.

To be eligible, participants must have confirmed extensive-stage small cell lung cancer that has progressed after at least one platinum-based chemotherapy treatment. They need to provide either an archived or fresh tumor tissue sample for analysis. If participants have HIV infection, it must be well controlled with antiretroviral therapy. The study is open to both male and female participants who are not part of vulnerable populations.

Exclusion criteria include having a different type of cancer, being outside the specified age range, belonging to a vulnerable population, not meeting health requirements, currently participating in another trial, having certain medical conditions that could interfere with the study, being pregnant or breastfeeding, or having allergies to study medications.

Both medications are given through intravenous infusion. I-DXd is administered every two weeks as monotherapy, while the combination schedule may vary. MK-6070 is being tested for safety and effectiveness in combination with I-DXd or alone. I-DXd is an antibody-drug conjugate that delivers a cytotoxic agent directly to cancer cells, disrupting their growth and survival.

The study will monitor safety, tolerability, and effectiveness throughout treatment. Researchers will assess objective response rates, duration of response, and progression-free survival to understand how well these treatments work for patients who have not responded to previous therapies.

Study on Niraparib with Immunotherapy for Patients with SLFN11-Positive Extensive-Stage Small Cell Lung Cancer

This multicenter European trial investigates adding niraparib to immunotherapy maintenance treatment for patients with extensive-disease small cell lung cancer showing high SLFN11 expression. SLFN11 is a protein that may indicate better response to certain cancer treatments.

Eligible participants must have completed standard first-line chemo-immunotherapy, which includes 4 cycles of platinum-etoposide chemotherapy combined with an anti-PD-L1 antibody (either atezolizumab or durvalumab). Their cancer must not have progressed after this initial treatment, and they must be suitable for maintenance treatment with immune-checkpoint inhibition. Participants need normal blood, kidney, and liver function, an ECOG performance status of 0-2, be at least 18 years old, and provide written informed consent.

The study excludes patients without extensive-disease small cell lung cancer, those whose tumors lack high SLFN11 expression, patients whose cancer progressed after first-line treatment, those outside the specified age range, and vulnerable populations.

Niraparib is taken orally in tablet form and works by blocking the PARP enzyme, which helps repair DNA damage in cells. By preventing cancer cells from repairing themselves, niraparib can lead to their death. It is used alongside an anti-PD-L1 antibody, which helps the immune system fight cancer.

The primary goal is to evaluate progression-free survival at 3 months, along with overall survival and disease control rate. Researchers will also monitor any adverse events according to established criteria. The study aims to determine if adding niraparib to immunotherapy maintenance can improve outcomes for this specific group of patients.

Study on Pembrolizumab and Olaparib for Patients with Extensive-Stage Small-Cell Lung Cancer

This Italian trial evaluates a combination approach for treating extensive-stage small-cell lung cancer. The study investigates whether adding pembrolizumab and olaparib as maintenance therapy after initial chemo-immunotherapy can prevent cancer progression.

Participants must be at least 18 years old and able to swallow medications. They need a life expectancy of at least 12 weeks and the ability to follow the study plan. Required laboratory values include adequate organ function with specific measurements for blood counts, kidney function (creatinine or estimated glomerular filtration rate), and liver function (bilirubin, AST, ALT, and alkaline phosphatase within specified ranges).

Participants must have negative tests for HIV, hepatitis B, and hepatitis C. Female participants of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for at least 120 days after the last dose. Male participants must agree to use condoms during the study and for 3 months after the last dose when having intercourse with partners who can become pregnant.

Additional requirements include a confirmed diagnosis of small-cell lung cancer at extensive stage, available tumor tissue sample, no previous systemic treatment for extensive-stage disease, an ECOG performance status of 0-1, and measurable cancer lesions.

Pembrolizumab is an immunotherapy that helps the immune system recognize and attack cancer cells. Olaparib targets cancer cells by interfering with their DNA repair ability, leading to cancer cell death. The combination aims to enhance treatment effectiveness. Researchers will monitor progression-free survival, objective response rates, and overall survival, along with any side effects participants experience.

Study on Selpercatinib for Adults with Advanced or Metastatic Solid Tumors with RET Activation

This expanded access program provides selpercatinib to patients with locally advanced or metastatic solid tumors that have a specific genetic change called RET alteration. The study includes various cancer types such as non-small cell lung cancer, medullary thyroid cancer, colon cancer, breast cancer, pancreatic cancer, papillary thyroid cancer, and small cell lung cancer.

To be eligible, patients must be at least 18 years old with a confirmed diagnosis of a locally advanced or metastatic tumor showing evidence of RET alteration. They must not be eligible for any ongoing clinical trials involving selpercatinib due to clinical, geographic, or financial constraints but be considered good candidates for this treatment by their doctor and the study sponsor. Patients must have tried standard treatments that either did not work, caused intolerable side effects, or have no standard treatment available.

Additional requirements include adequate blood, kidney, and liver function as defined in study guidelines. Patients or their legally authorized representatives must be able to give consent and provide signed informed consent before any study-specific procedures. Both men and women who can have children must agree to use two effective methods of birth control during treatment and for 3 months after the last dose.

Selpercatinib is taken orally and works by targeting and inhibiting the activity of the RET protein, which is involved in cell growth and division. By blocking this protein, the medication can help slow down or stop cancer cell growth. The trial provides access to treatment for patients who have limited options available and aims to offer a potential therapeutic benefit for those with RET-altered cancers.

Study on the Use of 68Ga-EVG321 for Diagnosing Small Cell Lung Cancer in Patients

This German, Austrian, and Italian trial investigates a new imaging method using 68Ga-EVG321 for diagnosing small cell lung cancer. The tracer combines Gallium-68 (a radioactive chemical) with EVG321 (a protein-based compound) to help visualize how cancer behaves inside the body.

Eligible participants must be at least 18 years old with a confirmed diagnosis of small cell lung cancer through tissue or cell examination. They need an ECOG performance status of 0, 1, or 2, meaning they can perform daily activities with varying degrees of limitation. Participants must have tumor tissue available outside the body that can be evaluated. Female participants of childbearing potential must have a negative pregnancy test and use highly effective contraception or practice sexual abstinence from the first visit until at least 14 days after stopping treatment. Male participants who are sexually active with partners of childbearing potential must use condoms from the day of treatment until at least 14 days after, and must not donate semen during this period.

The study excludes patients without confirmed small cell lung cancer diagnosis, those outside the specified age range, and vulnerable populations needing special protection.

68Ga-EVG321 is administered through intravenous injection. After injection, participants undergo PET/CT scans at several time points to observe how the tracer distributes in the body, particularly in cancerous areas. These detailed images help researchers measure radioactivity levels in various organs and tissues over time. The study compares imaging results with traditional diagnostic methods to determine if 68Ga-EVG321 can provide more accurate information about cancer presence and help improve detection and management of small cell lung cancer.

Study of Hydroxychloroquine Effects in Patients with Resectable Head and Neck Cancer or Non-small Cell Lung Cancer

This Italian trial examines how hydroxychloroquine affects cancer cells and their surrounding environment in patients scheduled for surgery to remove head and neck cancer or non-small cell lung cancer. The medication is given before planned surgery to study its effects on both cancer cells and immune system cells around the tumor.

Participants must be at least 18 years old with resectable head and neck cancer (squamous cell carcinoma of the oral cavity or larynx) or resectable non-small cell lung cancer (lung squamous cell carcinoma or adenocarcinoma). They must have a QTc interval (heart rhythm measurement) lower than 450 milliseconds and an ECOG performance status between 0-2. The tumor must be measurable according to RECIST 1.1 criteria. For lung cancer patients specifically, PDL1 levels must be above 50%.

Female participants who can become pregnant must use effective birth control during the study and for 4 weeks after completing medication. Male participants must use condoms or other effective birth control methods with partners during the study period.

The study excludes patients with non-resectable cancer, cancer types other than those specified, those under 18 years old, patients unable to provide informed consent, those with known allergies to hydroxychloroquine, patients currently participating in other trials, those with severe heart, liver, or kidney problems, patients with conditions that could interfere with the study medication (including severe visual impairment, blood disorders, or seizure disorders), and pregnant or breastfeeding women.

Hydroxychloroquine is taken orally with a maximum daily dose of 1200 mg for up to 15 days before surgery. After surgery, researchers examine the removed tumor tissue to understand how the medication affected cancer cells and surrounding tissue, looking for specific markers showing changes in tumor cells and immune system responses.

Study on Ifinatamab Deruxtecan and Topotecan for Patients with Relapsed Small Cell Lung Cancer

This large European trial compares ifinatamab deruxtecan (I-DXd), a novel antibody-drug conjugate, with standard chemotherapy for patients whose small cell lung cancer has returned after initial treatment. The study takes place across 13 countries including Germany, Poland, Romania, Greece, Hungary, Czechia, Italy, Spain, Belgium, France, Netherlands, Portugal, and Austria.

Eligible participants must be at least 18 years old (or the legal age of consent if higher) and sign informed consent before starting any study procedures. They must have confirmed small cell lung cancer diagnosis through specific medical tests and provide a good quality tumor tissue sample. Patients should have received only one previous treatment with platinum-based therapy, including at least two cycles with a minimum 30-day break from chemotherapy. They need at least one measurable tumor according to RECIST v1.1 guidelines and proof of disease progression on or after the most recent treatment. An ECOG Performance Status of 0 or 1 is required, meaning participants are fully active or restricted in physically strenuous activity but able to do light work. Patients can have brain metastases if they are untreated and not causing symptoms, or if they have been treated and no longer cause symptoms, and do not need steroids or anticonvulsants.

The trial excludes patients with cancer types other than small cell lung cancer, those outside the specified age range, and vulnerable populations.

I-DXd is an antibody-drug conjugate that targets B7-H3 proteins on cancer cells to deliver a toxic drug directly to them, aiming to kill cancer cells while sparing healthy ones. It is administered intravenously. The study randomly assigns participants to receive either I-DXd or a treatment chosen by their physician (topotecan or other chemotherapy options). Researchers will monitor cancer response, survival duration, and safety throughout the trial to determine if I-DXd is more effective than standard chemotherapy.

Summary

The clinical trial landscape for small cell lung cancer demonstrates significant international research effort, with studies concentrated primarily in European countries. Italy and Spain lead with the highest number of trials (11 and 10 respectively), followed by Germany, Poland, France, Belgium, and the Netherlands. This geographic distribution reflects strong research infrastructure and patient populations in these regions.

Several notable patterns emerge from these trials. Immunotherapy-based approaches dominate current research, with multiple studies investigating checkpoint inhibitors like atezolizumab, durvalumab, pembrolizumab, and nivolumab, either alone or in combination with chemotherapy. This reflects the field’s focus on harnessing the immune system to fight cancer. Several trials specifically target patients with limited-stage disease following chemoradiotherapy, examining whether immunotherapy can extend the benefits of initial treatment.

Another significant trend is the investigation of antibody-drug conjugates, particularly ifinatamab deruxtecan and patritumab deruxtecan, which represent a newer class of targeted therapies designed to deliver toxic agents directly to cancer cells. These medications are being studied across multiple countries in large-scale trials.

The trials also address specific patient populations based on biomarkers, such as SLFN11 expression, RET alterations, and KRAS-G12D mutations, reflecting a move toward more personalized medicine approaches. This precision medicine strategy aims to identify which patients are most likely to benefit from particular treatments.

Many studies focus on second-line and later treatment settings, recognizing the challenging nature of relapsed or refractory small cell lung cancer. This emphasis addresses a critical unmet need, as treatment options become limited after initial therapy fails. The research portfolio includes both maintenance therapy approaches to prevent recurrence and salvage therapies for progressive disease.

The diversity of investigational drugs being tested—from novel immunotherapies and antibody-drug conjugates to PARP inhibitors and targeted therapies—demonstrates the field’s commitment to finding more effective treatments through multiple mechanistic approaches. This comprehensive research effort offers hope for improving outcomes in this aggressive disease.

#1 Clinical Trials Search in Europe

Small cell lung cancer – Trials in Disease

Clinical Trials for Small Cell Lung Cancer: Current Research and Treatment Options

Clinical trial locations

Study of Atezolizumab and Chemotherapy for Patients with Relapsed Small Cell Lung Cancer

Study of BT-001 and Pembrolizumab for Patients with Advanced Solid Tumors, Including Sarcoma, Merkel Cell Carcinoma, Melanoma, Breast, and Lung Cancer

Study of Durvalumab for Patients with Limited Stage Small Cell Lung Cancer After Chemoradiotherapy

Study of Tarlatamab for Patients with Metastatic or Advanced Small-Cell Lung Cancer and Neuroendocrine Carcinomas

Study on MK-6070 and Ifinatamab Deruxtecan for Patients with Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer

Study on Niraparib with Immunotherapy for Patients with SLFN11-Positive Extensive-Stage Small Cell Lung Cancer

Study on Pembrolizumab and Olaparib for Patients with Extensive-Stage Small-Cell Lung Cancer

Study on Selpercatinib for Adults with Advanced or Metastatic Solid Tumors with RET Activation

Study on the Use of 68Ga-EVG321 for Diagnosing Small Cell Lung Cancer in Patients

Study of Hydroxychloroquine Effects in Patients with Resectable Head and Neck Cancer or Non-small Cell Lung Cancer

Study on Ifinatamab Deruxtecan and Topotecan for Patients with Relapsed Small Cell Lung Cancer

Summary

Ongoing Clinical Trials on Small cell lung cancer

A study to investigate the safety and effects of ceralasertib, tremelimumab, and durvalumab in adults with various solid tumors

Study of BNT327 with etoposide and carboplatin compared to atezolizumab with etoposide and carboplatin for patients with untreated extensive-stage small-cell lung cancer

Study of Durvalumab for Patients with Limited Stage Small Cell Lung Cancer After Chemoradiotherapy

Study on MK-6070 and Ifinatamab Deruxtecan for Patients with Relapsed or Refractory Extensive-Stage Small Cell Lung Cancer

Study on Niraparib with Immunotherapy for Patients with SLFN11-Positive Extensive-Stage Small Cell Lung Cancer

Study on BI 764532 for Patients with Relapsed or Refractory Small Cell Lung Cancer and Other Neuroendocrine Carcinomas

Study on the Use of 68Ga-EVG321 for Diagnosing Small Cell Lung Cancer in Patients

Study on the Safety and Effectiveness of AL8326 for Patients with Small Cell Lung Cancer Needing Second-Line Treatment

BMS-986525 Alone and with Nivolumab in Patients with Relapsed or Refractory Small Cell Lung Cancer

Study on the Safety and Effectiveness of AL8326 for Patients with Small Cell Lung Cancer Needing Second-Line Treatment

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Small cell lung cancer – Trials in Disease

Clinical Trials for Small Cell Lung Cancer: Current Research and Treatment Options

Clinical trial locations

Summary

Ongoing Clinical Trials on Small cell lung cancer

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