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Carcinoma, Neuroendocrine clinical trials

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NCT ID: NCT06440057 Not yet recruiting - Clinical trials for Neuroendocrine Carcinoma

Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma.

Start date: June 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicenter, open-label phase I/II study, divided into 2 parts: Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic results for use in Part 2. Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with Neuroendocrine Carcinoma.

NCT ID: NCT06424665 Not yet recruiting - Clinical trials for Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)

A Study of FZ-AD005 in Patients With Advanced Solid Tumors

Start date: May 30, 2024
Phase: Phase 1
Study type: Interventional

A First-in-Human, Open Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of FZ-AD005 in Patients with Advanced Solid Tumors.

NCT ID: NCT06418087 Recruiting - Clinical trials for Pulmonary Large-cell Neuroendocrine Carcinoma

Durvalumab With Carboplatin and Etoposide Chemotherapy in Pulmonary Large-cell Neuroendocrine Carcinoma (LCNEC)

DUPLE
Start date: May 27, 2022
Phase: Phase 2
Study type: Interventional

A prospective multicenter, single-arm phase II study enrolling treatment-naïve patients with metastatic pulmonary large-cell neuroendocrine carcinoma (LCNEC)

NCT ID: NCT06406465 Not yet recruiting - Clinical trials for Carcinoma, Neuroendocrine

A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity

Start date: June 26, 2024
Phase: Phase 2
Study type: Interventional

Background: High-grade neuroendocrine carcinomas (HGNEC) are cancers that develop in different parts of the body, including the digestive tract, genitals, neck, and head. One drug (belinostat), combined with 2 other drugs (etoposide and cisplatin), is approved to treat HGNEC. But some people may have a gene variant that affects how quickly their body gets rid of the drug; these people may do better with different dosages of belinostat. Objective: To test higher or lower doses of belinostat based on gene variants in people with HGNEC. Eligibility: People aged 18 years and older with HGNEC. Design: Participants will be screened. They will have a physical exam with blood tests. Some blood will be used for genetic testing. They will have imaging scans and a test of their heart function. Samples of tumor tissue may be collected. All 3 study drugs (belinostat, etoposide, cisplatin) are given through a tube attached to a needle inserted into a vein. Treatment will be given in 21-day cycles. For cycles 1 through 6: Participants will come to the clinic for the first 4 days. They will be given all 3 drugs. Imaging scans and other tests will be repeated. Each visit will last 4 to 8 hours. After cycle 6: Participants may continue treatment with belinostat alone. They will come to the clinic for the first 3 days of each cycle. They may continue treatment for up to 5 years if the drug is helping them. Participants will have a follow-up visit 30 days after their last dose of belinostat. Then they will receive follow-up visits by phone or email every 3 to 6 months.

NCT ID: NCT06400654 Recruiting - Clinical trials for Neuroendocrine Carcinoma

PrognostIc and Predictive Factors in Unresectable Locally Advanced NEC and MANEC

NIRVANA
Start date: July 5, 2021
Phase:
Study type: Observational

Extra-pulmonary (EP) poorly differentiated neuroendocrine carcinomas (NECs) represent a rare and aggressive category of neoplasms. Mixed adeno-neuroendocrine carcinomas (MANEC) are a group of rare neoplasms composed by a neuroendocrine (NE) and a non-neuroendocrine (non-NE) component, each representing at least the 30% of the neoplasm. Considering their rarity, low prevalence and poor prognosis a clear clinical, morphological and biomolecular characterization of these neoplasms has been prevented and a clinical approach universally shared is still lacking.

NCT ID: NCT06393816 Not yet recruiting - Clinical trials for Large Cell Neuroendocrine Carcinoma of the Lung

FIRST-NEC (GFPC 01-2022) - Combination of Durvalumab With Etoposide and Platinum

FIRST-NEC
Start date: May 2024
Phase: Phase 2
Study type: Interventional

The primary objective is to determine the efficacy (Progression-Free Rate at 12 months) of durvalumab combined with etoposide and platinum (either cisplatin or carboplatin) for the first-line treatment of patients with advanced LCNEC confirmed by centralized expert-pathologist review

NCT ID: NCT06384482 Recruiting - Clinical trials for Recurrent/Refractory Small Cell Lung Cancer Lung Large Cell Neuroendocrine Carcinoma

SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Carcinoma

Start date: April 30, 2024
Phase: Phase 1
Study type: Interventional

This study is a FIH dose escalation clinical study, with single arm, open label and design, in order to observe the preliminary safety and Pharmacokinetic of SNC115 Injection in participants with Recurrent/refractory small cell lung cancer and Lung large cell neuroendocrine carcinoma.

NCT ID: NCT06372626 Recruiting - Clinical trials for Neuroendocrine Carcinoma

Study of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.

Start date: May 30, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment.

NCT ID: NCT06369181 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Neuroendocrine Transformation in RB1/TP53 Inactivated NSCLC

Start date: January 1, 2021
Phase:
Study type: Observational

Histology transformation from non-small cell lung cancer (NSCLC) to neuroendocrine carcinomas (NEC), especially from epidermal growth factor receptor (EGFR) mutant lung adenocarcinoma (LADC) to small cell lung cancer (SCLC), is widely recognized as a rare mechanism for NSCLC to confer tyrosine kinase inhibitors (TKIs) resistance. The probability of its occurrence is about 3-14% in NSCLC patients who are resistant to TKI treatment. In addition to EGFR mutations, NSCLC patients carrying ALK/ROS1 mutations and receiving corresponding TKI treatment may also experience NEC transformation(NET). In a previous study [Pubmed ID: 35609408], the investigators demonstrated that NET also develops in NSCLCs without TKI targets or treatments. This phenomenon could be under-recognized, because re-biopsy was less frequently performed in these patients. The investigators had also shown that p53/Rb inactivation might correlated with NET and should be considered for NET risk prediction. In another retrospective studies, it was found that NSCLC patients with RB1/TP53 dual inactivation mutations had a significantly higher probability of NEC pathological transformation than those without RB1/TP53 inactivation mutations (43 times higher than those without mutations). Therefore, the subgroup of NSCLC patients with tumor suppressor gene RB1/TP53 dual inactivation might have elevated risk for NET. In this study, the investigators proposed to prospectively follow up NSCLC patients with dual RB1/TP53 inactivation (approximately 5% of the total NSCLC). Through prospective and systematic collection of baseline pathological information, clinical treatment process, and imaging data, and as much as possible, repeat pathological biopsies will be performed during disease progression.

NCT ID: NCT06337760 Recruiting - Adenocarcinoma Clinical Trials

YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs.

YOUNGSTER
Start date: March 10, 2023
Phase:
Study type: Observational

The objective of the study is to create a common and unique platform for the acquisition of biological samples and, subsequently, the possible identification of predictive and prognostic biomarkers for young adults with gastrointestinal and neuroendocrine cancers.The definition "adolescent and young adults (AYA)" covers a broad group of patients ranging from the upper limit of the paediatric competence to the youngest patients usually considered and treated as adults. However, a well-defined and universally accepted age range is still not established. Young adults with cancer have distinct epidemiological, biological, and clinical characteristics, as well as special medical and psychosocial needs that are often unmet. In consideration of their poor representation in clinical studies, as well as the rarer, albeit increasing, frequency at an epidemiological level, knowledge of the risk factors associated with cancers in young adults is very poor. It is therefore of fundamental importance to focus attention on this specific cohort of patients, in order to describe in ever more detail any specific biomolecular aspects, and make full use of the pharmacological resources currently available.