Chemotherapy for advanced neuroendocrine carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to improve chemotherapy regimens for patients with metastatic Grade 3 poorly differentiated neuroendocrine carcinoma (NEC) of gastro-entero-pancreatic origin or unknown primary. The study will compare the mFOLFIRINOX regimen against the standard platinum-etoposide regimen to determine which is more effective. Additionally, the trial will focus on identifying predictive biomarkers to personalize treatment based on the molecular characteristics of the tumors. The goal is to enhance patient outcomes by tailoring chemotherapy to individual tumor profiles.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Grade 3 neuroendocrine carcinoma or high grade MiNEN with a grade 3 poorly differentiated neuroendocrine carcinoma component ≥30% of gastro-entero-pancreatic or unknown primary

  * Poorly differentiated
  * Small cell or large cell or non-small cell or non- typeable
  * Metastatic disease
  * First-line, no prior therapy for metastatic disease, no prior use of carboplatin, oxaliplatin, cisplatin, etoposide, irinotecan and 5-fluorouracile
  * At least one measurable lesion as assessed by CT-scan or MRI according to RECIST 1.1 guidelines
  * Available tumor block
  * ANC ≥ 1.5x109/l, platelet ≥ 100x109/l and hemoglobin \> 8 g/dl
  * Total bilirubin ≤ 1.5N, AST ≤ 2.5N, ALT≤ 2.5N or AST/ALT ≤ 5N in case of liver metastases.
  * Age ≥ 18 years
  * ECOG Performance Status ≤ 1
  * Signed and dated informed consent, and willing and able to comply with protocol requirements.
  * Women of childbearing potential, as well as men (who have sexual relations with women of childbearing potential) must agree to use an effective method of contraception throughout this study and during the 15 months following administration of the last dose of the study medicinal product
  * Patient who is a beneficiary of the Social security system

Exclusion Criteria:

* Grade 3 well differentiated neuroendocrine tumor according to WHO 2017 classification

  * Severe renal impairment (creatinine clearance less than 30 mL/min, MDRD)
  * Partial or complete Dihydropyrimidine Dehydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)
  * Gilbert's syndrome
  * Pre-existing permanent neuropathy (NCI CTC V4.0 grade ≥2)
  * Previously treated by chemotherapy or targeted therapy
  * Brain metastases unless they are asymptomatic or under stable corticosteroid doses for 2 weeks otherwise. Radiation therapy prior to inclusion is required if symptomatic.
  * Combination with sorivudine and others analogues as brivudine (irreversibly inhibits the enzyme dihydropyrimidine dehydrogenase)
  * Treatment with St John's Wort (Hypericum perforatum)
  * Pregnant women or breastfeeding mother
  * Known or historical active infection with HIV, or known active infection untreated with hepatitis B or hepatitis C
  * History of prior malignancy, except for cured non-melanoma skin cancer, cured in situ cervical carcinoma, or other treated malignancies with no evidence of disease for at least three years.
  * Active or suspected acute or chronic uncontrolled disease that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
  * vaccinations (live vaccine) within 30 days prior to start of study drugs
  * Patient under guardianship and/or deprived of his/her freedom
  * QT/QTc interval \> 450 msec for male and \> 470 msec for female at EKC.
  * K+ \< LLN, Mg²+ \< LLN, Ca²+ \< LLN
  * History or know hypersensitivity to any of the study chemotherapy agents, or their excipients

Where it's running

• Chu de Caen
  Caen, France Recruiting
• Chu Dijon Bourgogne
  Dijon, France Recruiting
• Institut de Cancérologie de Bourgogne
  Dijon, France Recruiting
• Chu de Limoges - Dupuytren
  Limoges, France Recruiting
• Centre Hospitalier de Saint Malo
  St-Malo, France Recruiting
• CH de Troyes
  Troyes, France Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Autologous B7-H3 CAR T Cells in Advanced Small Cell Lung Cancer and Extrapulmonary Neuroendocrine Cancer

  This study tests a patient’s own B7-H3 CAR T cells to see if they can help people 18 and older whose small cell lung cancer or EPNEC has come back or hasn’t responded to prior treatment.

  Recruiting Phase 1 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07509034

• ZG006 plus ZG005 for advanced small cell lung cancer and neuroendocrine carcinoma

  This trial tests whether the combination of ZG006 and ZG005 helps adults with advanced small cell lung cancer or neuroendocrine carcinoma.

  Recruiting Phase 1/2 Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Guanzhou, Guangdong · NCT07038096

• Tarlatamab versus standard chemotherapy for pre-treated advanced pulmonary (large-cell) or gastroenteropancreatic poorly differentiated neuroendocrine carcinomas

  This trial tests whether tarlatamab helps adults with DLL3-positive, pre-treated advanced pulmonary (large-cell) or gastroenteropancreatic poorly differentiated neuroendocrine carcinomas compared with standard chemotherapy.

  Recruiting at 40 sites Phase 3 Intergroupe Francophone de Cancerologie Thoracique · Angers and 39 other locations · NCT06937905

• Testing a new treatment for advanced neuroendocrine tumors

  This study is testing a new treatment combining a virus with two cancer drugs to see if it helps people with advanced neuroendocrine tumors feel better and tolerate the treatment well.

  Recruiting Phase 1 University of Miami · Miami, Florida · NCT06889493

• Testing ZG006 for advanced small cell lung cancer and neuroendocrine carcinoma

  This study is testing a new drug called ZG006 to see if it is safe and effective for people with advanced small cell lung cancer or neuroendocrine carcinoma.

  Recruiting Phase 1/2 Suzhou Zelgen Biopharmaceuticals Co.,Ltd · Beijing, Beijing Municipality · NCT06440057

• Understanding how non-small cell lung cancer transforms into neuroendocrine carcinoma

  This study is trying to see how non-small cell lung cancer changes into a different type called neuroendocrine carcinoma in patients with certain gene mutations who have stopped responding to their current treatments.

  Recruiting Fudan University · Shanghai, Shanghai Municipality · NCT06369181

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.