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NCT06646276
The Purpose of the Study is to Compare the Efficacy and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.
NCT07328490
Background: Small-cell lung cancer (SCLC) is the most deadly form of lung cancer. It kills at least 250,000 worldwide each year. Extra-pulmonary neuroendocrine cancer (EP-NEC) is a similar type of cancer that develops anywhere other than the lungs. EP-NEC is also very aggressive. Better treatments are needed for these cancers. Objective: To test 2 drugs (tarlatamab combined with sacituzumab govitecan \[SG\]) in people with SCLC or EP-NEC. Eligibility: People aged 18 years and older with SCLC or EP-NEC that either did not respond to or returned after treatment. Design: Participants will be screened with a physical exam, blood tests, heart function testing, and imaging scans. Both study drugs are given intravenously (through a needle in the arm). Participants will receive a small starter dose of tarlatamab (1 mg) 2 weeks before beginning regular treatment, followed by the full dose (10 mg) one week later. Treatment then follows a repeating 4-week cycle: tarlatamab (10 mg) on days 1 and 15, and sacituzumab govitecan (7.5 or 10 mg/kg) on days 1 and 8. Treatment continues for up to 2 years, unless the cancer worsens, the participant passes away, or side effects become too severe. Participants will have regular check-ups including physical exams, blood tests, and imaging scans to monitor safety and treatment response. Blood and tumor samples will be collected for research purposes. After stopping treatment, participants will return for a safety check at 30 days, then be contacted every 3 months to check on their health and survival. Those who stop treatment for reasons other than cancer progression will continue CT scans every 8 weeks until their disease progresses.
NCT07390565
Globally, lung cancer stands as the foremost cause of cancer-related mortality. Among its subtypes, small cell lung cancer (SCLC) represents an exceptionally aggressive malignancy, accounting for approximately 15-20% of all lung cancer cases. Over two-thirds of SCLC patients are diagnosed at an extensive stage, facing a median survival of only 7-12 months, a 2-year survival rate below 5%, and a dismal 5-year survival rate of 2%, underscoring its poor prognosis and high mortality. First-line treatment for extensive-stage SCLC typically involves comprehensive therapy centered on chemotherapy, often combined with immunotherapy. While this approach can achieve response rates of 50-70%, it is frequently accompanied by significant adverse effects, including bone marrow suppression and debilitating gastrointestinal reactions such as nausea, vomiting, and anorexia. The considerable toxicity associated with chemotherapy poses a major clinical challenge, limiting the potential for dose or duration escalation and hindering further efficacy gains. Therefore, developing strategies to mitigate toxicity while enhancing therapeutic efficacy remains an urgent clinical priority. In the paradigm of Traditional Chinese Medicine (TCM), extensive-stage SCLC is categorized under syndromes such as "pulmonary accumulation," "cough," and "consumptive disease." Its fundamental pathogenesis is characterized by a deficiency of healthy qi (vital energy) alongside an excess of pathogenic factors, primarily "toxins," "stasis," and "phlegm." The core pathological mechanism involves the internal accumulation of toxins, disruption of the lung's dispersing and descending functions, disharmony of qi and blood, and consequent depletion of vital qi over time. Treatment strategies thus aim to resolve toxins, dispel stasis, and reinforce the body's vital qi. Preliminary clinical observations suggest that the TCM formula Yishen Qutong Granules, developed based on the theories of "reinforcing healthy qi to resolve toxins" and the "metal-water mutual generation" principle, can significantly alleviate symptoms in SCLC patients. Building on this foundation, the present study proposes to evaluate the integration of Yishen Qutong Granules with standard chemo-immunotherapy for extensive-stage SCLC, with the objectives of improving patients' quality of life and extending overall survival. To this end, investigators will conduct a multicenter, randomized, triple-blind, placebo-controlled clinical trial. A total of 308 patients with extensive-stage SCLC, who are scheduled to undergo first-line immunotherapy combined with etoposide and platinum-based chemotherapy, will be enrolled from participating centers. Participants will be randomly allocated in a 1:1 ratio to either the treatment group or the control group (n=154 each). The treatment group will receive oral Yishen Qutong Granules (10g, three times daily) in addition to the standard chemo-immunotherapy regimen. The control group will receive an identical regimen of standard therapy along with a matched placebo granule. The intervention period for the herbal preparation/placebo is 90 days, and all patients will be followed for 18 months. The primary efficacy endpoint is the Disease Control Rate (DCR). Secondary endpoints include Overall Survival (OS), Progression-Free Survival (PFS), TCM syndrome score (assessed using a validated scale), St. George's Respiratory Questionnaire (SGRQ) score, EORTC QLQ-C30 quality of life score, cancer-related fatigue, and emotional status. Safety will be rigorously monitored through serial assessments of routine blood/urine/stool tests, hepatic and renal function panels, and electrocardiograms. This study aims to generate high-level evidence for the integrative TCM-Western medicine approach and elucidate the potential role of Yishen Qutong Granules in the comprehensive management of extensive-stage SCLC.
NCT04373369
The purpose of the study is to determine whether adding vorolanib to atezolizumab will improve the length of time that participants are cancer-free after receiving standard chemotherapy.
NCT04397003
The investigators hypothesize that a personalized neoantigen vaccine combined with durvalumab will improve the progression free survival of patients with extensive state small cell lung cancer (ES-SCLC).
NCT04774380
Study to determine the safety and tolerability profile of durvalumab with platinum (cisplatin or carboplatin) plus etoposide (EP) as first-line treatment in participants with extensive-stage small-cell lung cancer.
NCT06961201
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.
NCT06909383
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.
NCT04101357
This first-in-human (FIH) trial aimed to establish a safe dose of BNT411 as a monotherapy and in combination with atezolizumab, carboplatin and etoposide. BNT411 is a toll-like receptor 7 (TLR7) agonist which is expected to mount broad innate and adaptive immune reactions, especially in combination with cytotoxic therapies and immune checkpoint inhibitors.
NCT06748495
The phase III ASTRUM-005 study (NCT04063163) has demonstrated promising antitumor efficacy and well tolerability of first-line serplulimab combined with chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC). However, due to the strict eligibility criteria of randomized controlled trials (RCTs), real-world data on patients with more complex and varied conditions are currently lacking. This highlights the urgent need for real-world evidence to better understand the practical effectiveness and safety of treatments. ASTRUM-005R is a multicenter real-world study conducted in China, designed to evaluate the efficacy and safety of the first-line treatment serplulimab-based immunochemotherapy for ES-SCLC in real-world clinical practice. Additionally, it aims to compare its findings with the data of the randomized controlled phase III ASTRUM-005 trial (descriptive), providing insights into optimal treatment strategies for this patient population.
NCT03043599
The purpose of the safety run in Phase I portion of this study is to confirm the recommended Phase II dose of ipilimumab and nivolumab among participants treated with combined thoracic radiation therapy (30 Gy in 10 fractions) and nivolumab/ipilimumab following standard treatment with 4-6 cycles of platinum-based chemotherapy. The purpose of the Phase II portion of this study is to estimate the 6-month Progression Free Survival (PFS) rate among participants treated with ipilimumab and nivolumab with thoracic radiation therapy (30 Gy in 10 fractions) after standard treatment with 4 to 6 cycles of platinum based chemotherapy.
NCT06554535
Lung cancer remains a leading cause of cancer-related deaths worldwide, with small cell lung cancer (SCLC) accounting for 15-20% of all lung cancers. Extensive-stage SCLC (ES-SCLC) is associated with poor prognosis, with a median survival of 2-4 months without treatment. Although platinum-based chemotherapy is the standard first-line treatment, median survival remains under one year, highlighting the need for improved outcomes. Recent studies have demonstrated that combining PD-1 inhibitors with chemotherapy can significantly improve survival in ES-SCLC patients. Serplulimab, a novel PD-1 inhibitor, has shown promising results in extending overall survival when combined with chemotherapy in a Phase III trial. Additionally, aspirin has been found to enhance the anti-tumor effects of immunotherapy by inhibiting immune checkpoint proteins and reducing adverse events such as thrombosis and fever. This Phase II study aims to evaluate the efficacy and safety of combining serplulimab, platinum-based chemotherapy, and aspirin as a first-line treatment for patients with ES-SCLC.
NCT06497530
This is a single-arm, open-lable exploratory study of Lurbinectedin in combination with Serplulimab as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and Serplulimab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and Serplulimab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will receive lurbinectedin plus Serplulimab in the maintenance phase.
NCT04636762
Etoposide-cisplatin/ -carboplatin in combination with PD-L1 inhibitor for 4 cycles followed by maintenance therapy with PD-L1 inhibitor is currently the world-wide first-line treatment for extensive-stage small cell lung cancer. When 4 cycles of EC/EP chemotherapy combined with PD-L1 inhibitor are effective, guidelines recommend additional thoracic radiotherapy. In our study, the investigators bring radiotherapy forward, which means that after 2 cycles of EC/EP chemotherapy plus Atezolizumab, participants with response（PR/CR/SD）will receive concurrent radiotherapy and 2 cycles of EC/EP chemotherapy plus Atezolizumab, then maintenance therapy with Atezolizumab （Q3W）. The purpose of this study is to explore the safety and efficacy of Atezolizumab combined with concurrent chemoradiotherapy in untreated participants with extensive-stage small cell lung cancer.
NCT03711305
This randomized, double-blinded, placebo-controlled phase III, multicenter study is designed to evaluate the safety and efficacy of SHR-1316 in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC.
NCT03516084
Niraparib is a PARP inhibitor. The study is a 2:1 randomized, double-blind, placebo-controlled, multi-center,phase 3 study of ZL-2306 (niraparib) as maintenance therapy following first-line platinum-based chemotherapy in patients with extensive-stage disease small cell lung cancer (ED-SCLC) to evaluate the efficacy and safety.
NCT04056949
This phase II trial studies how well IBI308 combined with paclitaxel/albumin-bound paclitaxel work in treating participants with small cell lung cancer after failing to platinum-etoposide chemotherapy.
NCT03841136
To evaluate the progression free survival of patients with extensive stage small cell lung cancer treated with anlotinib combined with EP/CE regimen
NCT02772107
Temozolomide may delay progression in sequence with chemotherapy. This open-label, randomized,multicenter phase II trial was designed to evaluate the role of Temozolomide following 4 or 6 cycles of platinum-based first-line chemotherapy in patients with newly diagnosed estensive-stage SCLC.