BridgeMD
Compares treatment options for Neuroendocrine Carcinoma
Official title Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)
ClinicalTrials.gov ID: NCT06937905
What this study is testing
What is Tarlatamab?
Tarlatamab is an investigational medicine, being studied as a potential treatment for neuroendocrine carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Based on the efficacy of tarlatamab in patients with small-cell lung cancer, we aim to assess the efficacy of tarlatamab in patients with Advanced, pulmonary (large-cell only) or gastroenteropancreatic neuroendocrine carcinoma.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed Informed consent:
- people must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This...
- people must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing
- Age ≥ 18 years.
- WHO Performance status 0 - 1.
You likely can't join if
- Well-differentiated neuroendocrine tumor (NET G1, G2 and G3 according to digestive WHO 2017 classification or typical/atypical carcinoid tumor...
- Previous treatment targeting DLL3
- More than one line of systemic therapy in the metastatic setting. Chemotherapy for non-metastatic stage is not considered as first-line if there is a...
- Small cell lung NEC (except as a minor \<30% component in mixed tumors)
- Known EGFR activating mutation or ALK or ROS1 rearrangement for lung NEC
- Untreated or symptomatic central nervous system (CNS) metastases:
See the full eligibility criteria
Who can join
- Signed Informed consent:
- people must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related...
- people must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing
- Age ≥ 18 years.
- WHO Performance status 0 - 1.
- Life expectancy \> 12 weeks.
- Histologically proven and centrally confirmed poorly differentiated neuroendocrine carcinoma (NEC): large cells for lung NEC (WHO 2015 classification), and large and small cells for extra-gastroenteropancreatic...
- Expression of DLL3 in at least 1% of tumor cells (assessed on archived tissue, with possible pre-screening during first-line)
- Tumor progression following one platinum based line of therapy.
- Unresectable locally advanced or metastatic stage.
- At least one measurable target lesion according to RECIST v1.1 per investigator assessment. The radiological assessment has to be done within the timelines indicated.
- Adequate organ function: creatinine clearance \> 50 mL/min, Neutrophils count ≥ 1500/mm3; Platelets \> 100 000/mm3 ; Hemoglobin \> 9 g/dL; AST and ALT \< 3 x ULN (upper limit of normal) with total bilirubin ≤ 2 × ULN...
- Full recovery from all toxicities associated with prior treatment, to acceptable baseline status, or a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) grade of 0 or 1, except...
- Availability of tumor material for central review processes and translational research projects.
- Absence of any unstable systemic disease and any psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule.
- Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must...
- Men who are sexually active with women of childbearing potential will be instructed to adhere to contraception for a period of 6 months after the last dose of treatment.
- Patient covered by a national health insurance.
What rules you out
- Well-differentiated neuroendocrine tumor (NET G1, G2 and G3 according to digestive WHO 2017 classification or typical/atypical carcinoid tumor according to lung WHO 2015 classification)
- Previous treatment targeting DLL3
- More than one line of systemic therapy in the metastatic setting. Chemotherapy for non-metastatic stage is not considered as first-line if there is a time interval of at least 6 months between the last dose of...
- Small cell lung NEC (except as a minor \<30% component in mixed tumors)
- Known EGFR activating mutation or ALK or ROS1 rearrangement for lung NEC
- Untreated or symptomatic central nervous system (CNS) metastases:
- people with asymptomatic CNS metastases are eligible if clinically stable for at least 4 weeks and do not require intervention (including use of corticosteroids).
- people with treated brain metastases are eligible provided the following criteria are met:
- Subject is asymptomatic from brain metastases
- Whole brain radiation or surgery was completed at least 2 weeks prior to first dose of study treatment (stereotactic radiosurgery completed at least 7 days prior to first dose of study treatment)
- Any CNS disease is clinically stable, subject is off steroids for CNS disease for at least 5 days (unless steroids are indicated for a reason unrelated to CNS disease), and subject is off or on stable doses of...
- Leptomeningeal metastasis
- Patients with a recent history of other malignancies except adequately treated non-melanoma skin cancer, and curatively treated in-situ cancer. Patients with history of solid tumors, including adenocarcinoma, treated in...
- Major surgery within 28 days prior to initiation of study treatment.
- Myocardial infarction and/or symptomatic congestive heart failure (New York Head Association class \> class II) within 12 months prior to initiation of study treatment.
- History of arterial thrombosis (e.g. stroke or transient ischemic attack) within 12 months prior to initiation of study treatment.
- Symptoms and/or clinical and/or radiological signs suggestive of uncontrolled and/or acute active systemic infection within 7 days prior to first administration ofstudy treatment. Patient with active infection requiring...
- Known sensitivity and/or immediate hypersensitivity to any component of study treatment.
- History of primary immunodeficiency, history of organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization or a prior history of severe (grade 3...
- Patients with immune pneumonitis, pituitary or thyroid disorders, or pancreatitis under treatment with immuno-oncology agents.
- Patients reporting infusion-related reactions or severe, life-threatening or recurrent immune-mediated adverse events (grade 2 or higher), including events leading to permanent discontinuation of immuno-oncology agents.
- Presence of an indwelling line or drain (including the following: percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, peritoneal drain or catheter, pericardial drain or catheter, drain catheter or...
- Patient with a diagnosis of immunodeficiency or undergoing systemic corticotherapy or any other form of immunosuppressive therapy within 7 days prior to administration of the first dose of study treatment.
- Known acute or chronic B or C hepatitis by serological evaluation. Patients with serological sequellae of hepatitis (antibodies test serologically positive for virus) without hepatitis could be included.
- Known Human immunodeficiency virus infection
- Patients who are pregnant or breast-feeding, or planning to become pregnant or breast-feed during the trial and within 7 months after the last dose of study treatment.
- Male not wishing to abstain from sperm donation during the trial and within 6 months of the last study treatment.
- Vaccination with live or attenuated virus vaccines is not permitted during the 28 days prior to administration of the first dose of treatment, and for the duration of the study. Vaccination against severe acute...
- Active autoimmune disease requiring systemic therapy (except replacement therapy) within the last 2 years or any other disease requiring immunosuppressive therapy during the study.
- Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Avignon, France
- Besançon, France
- Boulogne, France
- Caen, France
- Chambray-lès-Tours, France
- Dijon, France
- Grenoble, France
- Le Mans, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Montpellier, France
- Nice, France
- Paris, France
- Pessac, France
- Pierre-Bénite, France
- Poitiers, France
- Reims, France
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Avignon, France; Besançon, France; Boulogne, France; Caen, France; Chambray-lès-Tours, France and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.