Active clinical trials for "Small Cell Lung Carcinoma"

This is a Phase 1b/2, single-arm, open-label, dose-escalation study including 2 stages: Phase 1b: Dose-Escalation Stage (Single-Dose and Consecutive-Dose Periods) Phase 2: recommended Phase 2 dose (RP2D) of chiauranib will be given to all patients enrolled in this phase once daily for 28-day cycles continuously with no interruption between cycles.

This study aims to establish a safe and well tolerated dose of [177Lu]Lu-DOTA-TATE in combination with carboplatin, etoposide, and tislelizumab in induction treatment and with tislelizumab in maintenance treatment in newly diagnosed patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC).

SCLC has short doubling time, high proliferation rate and early widespread metastasis. Most patients with SCLC have hematogenous metastasis. SCLC is highly sensitive to initial chemoradiotherapy, but the recurrence rate is high. The strategy for local limited SCLC patients was chemotherapy plus chest radiotherapy; In patients with extensive stage SCLC, first-line platinum-based chemotherapy has been established as the standard treatment for patients with small cell lung cancer (SCLC) with better results. Although the initial response to chemotherapy is high, it is easy to relapse and develop drug resistance. In second-line therapy, the single-agent activity of multiple chemotherapy agents has been demonstrated, but a higher incidence of grade 3-4 hematological adverse events In the Passion study published by Wang Jie et al. [10], the efficacy and safety of the antiangiogenic drug apatinib combined with carrizumab in the second-line treatment of small cell lung cancer were investigated. A total of 59 patients were enrolled in the study. Of the 47 patients in the extended phase, the confirmed ORR was 34.0% (95%CI 20.9-49.3), with a median PFS of 3.6 months and a median OS of 8.4 months In patients with platinum sensitivity and platinum resistance, ORR was 37.5% vs 32.3%, MPFS was 3.6m vs 2.7m, and MOS was 9.6m vs 8.0m. Grade 3 treatment-related adverse events (TRAEs) occurred in 43 of the 59 patients (72.9%), and 5 patients (8.5%) were discontinued due to TRAEs. The combination regimen showed potential antitumor activity in both platinum-sensitive and platinum-resistant cases. The research and exploration of small cell lung cancer can learn from the research idea in the field of non-small cell lung cancer. The Checkmate9LA study reported in 2020ASCO [11] investigated the safety and efficacy of Nivolumab+2 cycle chemotherapy in first-line treatment of non-small cell lung cancer with negative driver gene. The MOS in the immunization combination group was significantly better than that in the chemotherapy group (15.6 months vs. 10.9 months, HR 0.66), and the 1-year survival rate was 63% vs. 47%, respectively. The ORR in the immunization combination group was also improved (38% vs. 25%), and the MDOR was 11.3m vs. 5.6m, which was tolerable in terms of safety. The incidence of grade 3-4 treatment-associated AE was 47% in the immune-combined group and 38% in the chemotherapy group. From the perspective of mechanism, chemotherapy can enhance the immunogenicity of tumor cells, damage the immune cell inhibitory activity, which can induce tumor cell apoptosis, expression of MHC class 1 molecules increases and mature dendritic cells to promote the immune response, in the design, add 2 cycles of chemotherapy short-term intensive treatment, make up the immune short board, For example, the early onset of slow and immune characteristic events such as large tumor load, pseudo progression, hyperrogression and other problems, to achieve the optimization and upgrading of the scheme. Based on Rationale 307, Tislelizumab was approved on January 12, 2021 for first-line treatment in combination with paclitaxel and carboplatin in patients with locally advanced or metastatic squamous non-small cell lung cancer. t the same time, Tislelizumab initial efficacy in patients with extensive small-cell lung cancr.Rational-206 study is a phase Ⅱ multi-cohort study of Tislelizumab combined with first-line platinum-containing chemotherapy in patients with advanced lung cancer in China. The MPFS in the SCLC cohort was about 7 months, and the MOS reached 15.6 months. Based on the above studies and data, in the second-line treatment of SCLC, anti-vascular targeted drugs combined with chemotherapy can obtain a certain survival benefit, especially for patients with sensitive recurrence, and the benefit is more significant. he immune checkpoint inhibitors have gradually emerged in the second-line and later treatment of SCLC, but the single drug effect has not been a great breakthrough; a small molecule antiangiogenic targeted drug in China, Anlotinib has obtained third-line and later indications of SCLC through ALTER1202 data, and has been included in the 2019 CSCO Guidelines for the Diagnosis and Treatment of Primary Lung Cancer. t the same time, it is similar to the Checkmate9LA study regimen, combined with two cycles of chemotherapy, to improve the short-term efficacy. Therefore, Anlotinib combined with Tislelizumab, a PD-1 inhibitor, and 2 cycles of Irinotecan monotherapy were tried in second-line SCLC, with the hope of breaking through the difficulties of high recurrence rate and rapid disease progression of existing second-line SCLC chemotherapy, regardless of platinum-sensitive recurrence or platinum-resistant recurrence, and providing more options for SCLC patients.

To show that maintenance therapy with Tislelizumab plus Anlotinib will prolong Progression Free Survival in subjects with extensive stage disease small cell lung cancer who have completed first line chemotherapy.

The purpose of this study is to compare overall survival (OS) and progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR). Hypothesis (H1): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H2): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to PFS per RECIST 1.1 by BICR. Hypothesis (H3): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab plus olaparib is superior to concurrent chemoradiation therapy alone with respect to OS. Hypothesis (H4): Concurrent chemoradiation therapy with pembrolizumab followed by pembrolizumab is superior to concurrent chemoradiation therapy alone with respect to OS.

This phase II trial studies the effects of durvalumab and lurbinectedin in treating patients with extensive stage small cell lung cancer that has come back (relapsed) or has not responded to previous treatment with chemotherapy and immunotherapy (refractory). Monoclonal antibodies, such as durvalumab, may interfere with the ability of tumor cells to grow and spread. Lurbinectedin is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in the body. Giving durvalumab and lurbinectedin may help kill more tumor cells and help patients live longer.

This phase II trial investigates how well ZEN-3694, enzalutamide, and pembrolizumab work in treating patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). ZEN-3694 blocks the expression of the MYC gene to prevent cellular growth in certain types of tumors, including castrate resistant prostate cancer. Enzalutamide has been shown to block testosterone from reaching prostate cancer cells by binding to a receptor on prostate cancer cells, called androgen receptors. This works similar to a lock and key. When enzalutamide (key) inserts into the androgen receptor (lock) testosterone cannot attach to the androgen receptor, which slows the growth of tumor cells and may cause them to shrink. Pembrolizumab is a monoclonal antibody (proteins that can protect the body from foreign organisms, such as bacteria and viruses) designed to block a specific control switch which may be activated by tumor cells to overcome the body's natural immune system defenses. It also enhances the activity of the body's immune cells against tumor cells. The purpose of this study is to find out the effects ZEN-3694, enzalutamide, and pembrolizumab on patients with metastatic castration-resistant prostate cancer who have previously experienced disease progression.

This study is a single arm, multi-center, open label phase Ib/II study of SC0245 and Irinotecan combination therapy in subjects with extensive-stage small cell lung cancer (ES-SCLC) as a second therapy. This study will have three parts, phase 1 dose escalation (Part 1), phase 1 dose expansion (Part 2), and phase 2 combination therapy (Part 3).

This is an open-label, single-arm, prospective phase 2 study, evaluating the efficacy and safety of tislelizumab combined with Anlotinib as maintenance therapy following tislelizumab and chemotherapy for treatment naïve extensive stage small cell lung cancer.

24 participants are expected to be enrolled for this open，Single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus Ⅰ, R130 in patients with relapsed/refractory advanced solid tumors.