Extensive Stage Small Cell Lung Cancer (ES-SCLC)

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Review clinical trials related to Extensive Stage Small Cell Lung Cancer (ES-SCLC). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer

The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC). The primary objectives of this study are to compare the effect of SG to SOC on overall survival (OS).

Participants needed: 695
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Gilead SciencesUpdated: Jun 24, 2026Locations: 218
Eligibility criteria

Histologically confirmed diagnosis of SCLC. [+6]

Chemotherapy-free interval (CTFI) time from the last dose of first-line platinum... [+2]

Status: Recruiting

A Study to Evaluate DJI136, a DLL3-targeted CAR-T Therapy

This is a Phase I/II, open-label, non-randomized, multi-center study in patients with extensive-stage small cell lung cancer (ES-SCLC) to determine the recommended dose(s) (RD) and to evaluate the safety, tolerability and preliminary efficacy of DJI136.

Participants needed: 80
Trial details
Phase: Phase 1, Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Novartis PharmaceuticalsUpdated: Jun 23, 2026Locations: 4
Eligibility criteria

Phase I: Patients with ES-SCLC and disease progression after one or more chemoth... [+8]

Prior administration of a genetically modified cellular product, including prior... [+7]

Status: Recruiting

DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemotherapy

This study is open to adults with advanced small cell lung cancer (SCLC). The purpose of this study is to find out if a study medicine called obrixtamig plus standard treatment (atezolizumab, carboplatin, and etoposide) improves survival when compared to standard treatment alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker DLL3. Participants are put into 2 groups randomly, which means by chance. One group receives obrixtamig and standard treatment. The other group receives standard treatment without obrixtamig. All treatments are given as infusions into a vein. Participants are in the study for up to 3 years. During this time, they visit the study site regularly. Participants in the group receiving obrixtamig stay overnight at the study site following the first 2 obrixtamig treatments. At the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Participants needed: 670
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Boehringer IngelheimUpdated: Jun 23, 2026Locations: 237
Eligibility criteria

Patients with histologically confirmed Extensive-stage Small Cell Lung Cancer (E... [+7]

Presence of leptomeningeal disease and/or carcinomatous meningitis [+4]

Status: Recruiting

Sintilimab Combined With Tafolecimab and Chemotherapy as First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

This is a single arm, multi-center clinical trial. The goal of this clinical trial is to evaluate the efficacy, safety and biomarkers of Tafolecimab combined with Sintilimab and Chemotherapy as first-line treatment for patients with extensive-stage small cell lung cancer (ES-SCLC). Tafolecimab is a recombinant fully humanized monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (PCSK-9), which can reduce low-density lipoprotein-C levels and increase the expression level of major histocompatibility complex class I (MHC-I) on tumor cells. Sintilimab is a fully humanized IgG4 monoclonal antibody targeting programmed cell death protein 1 (PD-1).

Participants needed: 40
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Second Affiliated Hospital, School of Medicine, Zhejiang UniversityUpdated: Jun 23, 2026Locations: 5
Eligibility criteria

Age ≥18 years, ECOG performance status 0-1; [+5]

Previously receiving systemic anti-tumor therapy for ES-SCLC; [+16]

Status: Not yet recruiting

Nab-Paclitaxel Combined With Local Therapy in Relapsed SCLC

This is a prospective, single-arm, investigator-initiated clinical study (IIT) designed to evaluate the efficacy and safety of nab-paclitaxel combined with local radiotherapy for patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed after first-line treatment. Small cell lung cancer (SCLC) is an aggressive type of lung cancer, and extensive-stage SCLC (ES-SCLC) refers to its advanced stage. For patients whose cancer progresses after first-line treatment, there are very limited effective second-line and later-line treatment options. Commonly used clinical regimens such as topotecan and lurbinectedin only provide modest improvements in tumor response and survival, and often cause severe hematological toxicities (represented by bone marrow suppression). This leaves patients in a persistent dilemma of "insufficient efficacy and limited tolerability", highlighting a clear unmet medical need for better treatment options in this population. Against this background, this study explores a comprehensive treatment strategy using nab-paclitaxel as the chemotherapy backbone, combined with local radiotherapy in eligible patients. Nab-paclitaxel is a nanoparticle albumin-bound form of paclitaxel, with a relatively controllable toxicity profile and manageable administration in clinical practice. Local radiotherapy may create a synergistic effect by improving the tumor immune microenvironment and enhancing local tumor control, with the goal of providing better evidence for a "chemotherapy ± local therapy" combination as a second-line treatment option.

Participants needed: 84
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Shanghai Pulmonary Hospital, Shanghai, ChinaUpdated: Apr 23, 2026
Eligibility criteria

(1) Written informed consent has been signed. (2) Male or female, aged 18-75 yea... [+8]

Rash involves < 10% of body surface area; ② Disease is well controlled at baseli...

Status: Recruiting

Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

The goal of this clinical trial is to learn if the combination of sacituzumab govetican (SG) and atezolizumab/durvalumab is effective in controlling cancer tumor growth in adults with extensive stage small cell lung cancer. These drugs are FDA approved individually in different cancers. This combination is evaluated in breast cancer and showed promising combination. The effectiveness of this treatment combination will be measured by changes in tumor size and appearance of new tumors. Participants in the trial will: * receive treatment SG and immunotherapy every 21 days for up to 2 years or until it is no longer works for the patient. * CT scans at 6weeks for first 6 cycles and then every 9-12 weeks and MRI brain every 12 weeks. * provide tissue (optional) and blood for additional testing (learn about the cancer).

Participants needed: 35
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Bindu R PotugariUpdated: Apr 23, 2026Locations: 1
Eligibility criteria

Participant is willing and able to give informed consent for participation in th... [+8]

Significant renal impairment requiring dialysis or hepatic impairment with end-s... [+5]

Status: Not yet recruiting

Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC)

This is an single-arm, multicenter phase II study to evaluate the safety and efficacy of Sacituzumab Tirumotecan (sac-TMT) plus anlotinib in previously treated extensive-stage small cell lung cancer (ES-SCLC). The study is expected to enroll up to 33 eligible patients.

Participants needed: 33
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Sichuan UniversityUpdated: Apr 13, 2026Locations: 1
Eligibility criteria

1.Voluntary participation with written informed consent obtained prior to any st... [+12]

1.History of other primary malignancies within 5 years prior to signing informed... [+26]

Status: Recruiting

Iadademstat + SBRT With Atezo in ES-SCLC

This is a phase 1b dose escalation, open-label, non-randomized study of participants with residual, progressive or recurrent ES-SCLC who previously received platinum-based chemotherapy with or without immune checkpoint inhibitor therapy; participants who have achieved only stable disease at the completion of initial platinum-based treatment are eligible for enrollment.

Participants needed: 15
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Yale UniversityUpdated: Mar 27, 2026Locations: 1
Eligibility criteria

Signed informed consent form. [+20]

History of leptomeningeal disease. [+50]

Status: Recruiting

Tislelizumab Combined With Chemotherapy Followed by Thoracic Consolidation Radiotherapy in the First-line Treatment of Extensive Stage Small Cell Lung Cancer

This study is a prospective, single arm, phase II clinical trial. We plan to include 36 newly diagnosed ES-SCLC patients who meet the inclusion criteria and receive induction therapy (tislelizumab+EP regimen, 4-6 cycles). After completing the induction therapy, efficacy evaluation will be conducted. Patients with remission will receive tislelizumab combined with consolidation chest radiotherapy (TRT) sequentially. After the consolidation therapy is completed, they will receive tislelizumab maintenance therapy until disease progression, intolerable toxicity, or withdrawal of informed consent occurs, whichever occurs first. The treatment duration will not exceed 2 years.

Participants needed: 36
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Chongqing University Cancer HospitalUpdated: Feb 23, 2026Locations: 1
Eligibility criteria

Signed informed consent; [+8]

Symptomatic, untreated, or actively progressive central nervous system (CNS) met... [+7]

Status: Recruiting

Post-line Treatment With Teniposide for c-Myc-driven Extensive-stage Small Cell Lung Cancer

The study is being conducted to investigate the efficacy and safety of teniposide in patients with extensive-stage small cell lung cancer who have failed standard treatment and with high expression of the c-Myc-driven FBXW2/MYC gene. Based on the results, the study will explore the correlation between the expression of FBXW2/MYC and the efficacy of teniposide.

Participants needed: 15
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Shanghai Pulmonary Hospital, Shanghai, ChinaUpdated: Dec 5, 2025Locations: 1
Eligibility criteria

extensive stage small cell lung cancer [+6]

No measurable lesions [+4]

Status: Recruiting

A Study of Ivonescimab in First-Line ES-SCLC

The goal of this clinical trial is to learn if different combinations of a drug called Ivonescimab, along with chemotherapy and other investigational drugs, are safe and effective for the initial treatment of adults with extensive-stage small cell lung cancer (ES-SCLC). The main questions the study aims to answer are: * What side effects do participants experience from these combination treatments? * How well do the treatments work to shrink tumors? Researchers will compare three groups to see which combination works best. All participants will receive Ivonescimab and chemotherapy (etoposide and carboplatin). The differences are: * Group 1 will also receive an additional drug called AK117. * Group 2 will also receive a different additional drug called Cadonilimab. * Group 3 will receive Ivonescimab and chemotherapy only. Participants will: * Be assigned by chance to one of the three groups. * Undergo an initial treatment phase (about 3 months), receiving chemotherapy plus the specific study drugs for their group. * If the treatment is effective and side effects are manageable, continue with a maintenance phase using only the study drugs (without chemotherapy) for up to 2 years. * Attend regular clinic visits for check-ups, blood tests, and imaging scans (like CT scans) to see how they are responding to the treatment.

Participants needed: 180
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: AkesoUpdated: Nov 24, 2025Locations: 3
Eligibility criteria

Histologically or cytologically confirmed extensive-stage small cell lung cancer... [+5]

Active or untreated central nervous system (CNS) metastases (Treated, stable bra... [+8]

Status: Recruiting

Tislelizumab Combined With Chemotherapy and Relayed Radiotherapy in First-line Treatment of ES-SCLC

To explore the efficacy and safety of Tislelizumab combined with chemotherapy and relayed radiotherapy in the first-line treatment of extensive small cell lung cancer

Participants needed: 56
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Anhui Provincial Cancer HospitalUpdated: Sep 24, 2025Locations: 1
Eligibility criteria

Age≥18 years old, male or female, signed Informed Consent Form (ICF); [+5]

Active leptomeningeal disease or uncontrolled, untreated brain metastasis; [+7]

Status: Not yet recruiting

Organoid-guided vs Topotecan Therapy in Relapsed Extensive-Stage Small Cell Lung Cancer

This study aims to provide personalized treatment options for patients with extensive-stage small cell lung cancer (SCLC) whose disease has worsened after initial chemotherapy. Researchers will use a novel approach called "tumor organoid drug sensitivity testing": A small sample of the patient's tumor (from biopsy or fluid) is grown into miniature 3D tumor models ("organoids") in the lab. These organoids are exposed to various FDA-approved second-line drugs (including chemotherapy and newer targeted/immunotherapy drugs if available). The most effective drug for each patient's organoids will be recommended for their treatment. 128 participants will be randomly assigned to one of two groups:Experimental Group: Receive organoid-guided personalized therapy; Control Group: Receive standard second-line chemotherapy (Topotecan). The study will compare: How long the cancer remains controlled (Progression-Free Survival); Overall survival time; Treatment response rates and side effects. Potential benefits: May identify more effective treatments for individual patients; Could extend time without cancer progression. Risks: Organoid testing requires an additional tumor biopsy/fluid collection; Possible side effects from second-line drugs.

Participants needed: 128
Trial details
Phase: Phase 2, Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Peking Union Medical College HospitalUpdated: Aug 6, 2025
Eligibility criteria

Aged 18 years or older. [+10]

Mixed tumor pathology or lack of histological confirmation. [+7]

Status: Recruiting

Small Extracellular Vesicle miRNAs as Predictive Biomarkers for Immunochemotherapy Efficacy in Extensive-stage Small Cell Lung Cancer

This study aims to investigate the clinical value of small extracellular vesicle (sEV) miRNAs as predictive biomarkers for immunochemotherapy efficacy in extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC represents a highly aggressive neuroendocrine malignancy, where the current standard first-line treatment combining immune checkpoint inhibitors with chemotherapy lacks predictive biomarkers for individualized therapeutic strategies. A prospective observational cohort will be established at Shanghai Chest Hospital, enrolling treatment-naïve ES-SCLC patients. Distinct miRNA signatures differentiating responders from non-responders will be identified through pretreatment serum sEV miRNA sequencing and differential expression analysis. These findings may provide novel liquid biopsy biomarkers to guide personalized treatment strategies and optimize clinical decision-making in ES-SCLC management.

Participants needed: 38
Trial details
Age: 45-80Biological sex: AllType: ObservationalSponsor: Shanghai Chest Hospital of Shanghai Jiao Tong UniversityUpdated: Jul 17, 2025Locations: 1Duration: 38 Days
Eligibility criteria

The pathological diagnosis of the patient is ESSCLC; [+3]

Patients whose pathological diagnosis does not meet the requirements; [+3]

Status: Not yet recruiting

Phase 1 Study of HS-20093 Combinations in Patients With Extensive Stage Small Cell Lung Cancer

This is a Phase I clinical study of HS-20093. The purpose of this study is to evaluate the safety, tolerability, PK and efficacy of HS-20093 in combination with Adebrelimab in patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).

Participants needed: 50
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Shanghai Hansoh Biomedical Co., LtdUpdated: Jul 14, 2025
Eligibility criteria

Men or women aged more than or equal to (≥) 18 years. [+8]

Uncontrolled pleural effusion or ascites or pericardial effusion. [+8]

Status: Not yet recruiting

Nano-crystalline Megestrol Acetate Combined With Standard Treatment Versus Standard Treatment for First-line Extensive-stage Small Cell Lung Cancer in the Cachexia Phase

This study is a prospective, randomized, parallel-controlled clinical trial, aiming to evaluate the efficacy and safety of nano-crystalline megestrol acetate combined with standard treatment compared to standard treatment alone as first-line therapy for extensive-stage small cell lung cancer (ES-SCLC) in both the pre-cachexia and cachexia phases. Participants enrolled in the study are those with ES-SCLC in the pre-cachexia or cachexia phase who have not received systemic treatment and are not eligible for curative therapy.

Participants needed: 94
Trial details
Phase: Phase 3Age: 18-85Biological sex: AllType: InterventionalSponsor: Changchun GeneScience Pharmaceutical Co., Ltd.Updated: May 7, 2025Locations: 1
Eligibility criteria

Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. [+6]

Presence of conditions that may affect gastrointestinal absorption, such as dysp... [+4]

Status: Not yet recruiting

Nanocrystalline Megestrol Acetate for the Treatment of Anorexia-Cachexia Syndrome in Extensive-Stage Small Cell Lung Cancer: A Prospective, Open-Label, Single-Arm Phase II Clinical Study

Patients with extensive-stage small cell lung cancer are a high-risk group for cancer cachexia and anorexia. Meanwhile, the adverse reactions of chemotherapy and immunotherapy potentially exacerbate the occurrence and development of cancer cachexia and anorexia. Cancer cachexia and anorexia also severely affect the quality of life of patients with extensive-stage small cell lung cancer, significantly shortening their overall survival (OS) and progression-free survival (PFS), thus forming a vicious cycle. Numerous previous studies have shown that for patients with advanced tumors, the combination of supportive treatments such as megestrol acetate during chemotherapy or concurrent chemoradiotherapy is a treatment mode with clinical significance and practical feasibility in clinical practice. However, the efficacy and the optimal treatment timing of its combination with the current first-line immunochemotherapy regimen remain unclear. Although mechanistic studies have shown that anti-cachexia treatment may synergistically enhance the efficacy of immunotherapy, there is a lack of relevant clinical research evidence.

Participants needed: 41
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Guangzhou Institute of Respiratory DiseaseUpdated: Apr 3, 2025
Eligibility criteria

Active or untreated CNS metastases (e.g., brain or leptomeningeal metastases) de... [+17]

Status: Recruiting

Atezolizumab and Rechallenge Chemotherapy in Relapsed Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC).

The goal of this clinical trial is to learn if a combination of atezolizumab and standard chemotherapy works to treat sensitive Extensive-stage Small Cell Lung Cancer, progressing after first-line of treatment. The main questions it aims to answer are: * Does combination of atezolizumab and standard chemotherapy increase overall survival? * What medical problems do participants have when taking combination of atezolizumab and standard chemotherapy? Participants will: * take atezolizumab and standard chemotherapy every 3 weeks for 4 cycles and than atezolizumab every 3 weeks up to 18 cycles. * visit the clinic once every 3 weeks for checkups and tests * perform Radiological assessments after 6 weeks and then every 12 weeks to determine response to treatment.

Participants needed: 142
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: Gruppo Oncologico Italiano di Ricerca ClinicaUpdated: Mar 13, 2025Locations: 25
Eligibility criteria

Diagnosis of small-cell lung cancer (SCLC) (according to WHO classification 2015... [+20]

Recovered (i.e., ≤ grade 1 toxicity) from effects of prior anticancer therapy, e... [+28]

Status: Recruiting

Second-line Immunotherapy for ES-SCLC

At present, the first-line standard treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) is immunotherapy combined with chemotherapy. For patients who relapse within 6 months after first-line chemotherapy, conventionally recommended chemotherapy drugs include topotecan, irinotecan, gemcitabine, paclitaxel or vinorelbine, etc., but due to limited benefits to patients, patients are also recommended to participate in relevant clinical studies. New treatment methods are constantly being explored in second-line treatment, including fluzoparib combined with adebelimumab. The current status of second-line treatment is still worrying. Selinexor is a class of nuclear export selective inhibitors (SINEs) for the export protein receptor XPO1. PO1 promotes the transport of mRNA and cargo proteins, including tumor suppressor proteins (TSPs), hormone receptors (GRs), and immune response regulators. Selinexor covalently binds to the XPO1 protein, blocking the export of TSPs and GRs and accumulating them in the nucleus, preventing the translation of oncoprotein mRNA, stopping the cell cycle process, and initiating apoptosis. Multiple in vitro and in vivo studies have verified that selinexor combined with chemotherapy/radiotherapy/targeted therapy exhibits significant anti-tumor activity. This study plans to use selinexor combined with adebrelimab and albumin-paclitaxel as a second-line treatment for ES-SCLC to explore the efficacy and safety of this regimen.

Participants needed: 30
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Tianjin Medical University Cancer Institute and HospitalUpdated: Mar 3, 2025Locations: 1
Eligibility criteria

Age ≥ 18 years old, male or female; [+10]

Any active autoimmune disease or history of autoimmune disease with expected rec... [+14]

Status: Not yet recruiting

A Multicenter Real-World Cohort Study of Adebrelimab Injection in the Treatment of Extensive-Stage Small Cell Lung Cancer

The purpose of this observational study is to evaluate the safety and efficacy of Adebrelimab Injection in extensive-stage small cell lung cancer (ES-SCLC) under real-world conditions. Specifically, the study aims to assess the treatment of Adebrelimab Injection across various subgroups of ES-SCLC patients. The goal is to provide information on treatment patterns and effectiveness in real-life settings, explore potential predictive or prognostic biomarkers, and preliminarily evaluate the pharmacoeconomic indicators of Adebrelimab Injection treatment for extensive-stage small cell lung cancer.

Participants needed: 2,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Shanghai Pulmonary Hospital, Shanghai, ChinaUpdated: Jul 31, 2024
Eligibility criteria

Voluntarily sign the informed consent form and agree to participate in the study... [+3]

Evidence of being a pregnant or lactating female. [+2]