Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)
TARLANEC
A GCO Trial Exploring the Efficacy and Safety of Tarlatamab Versus Investigator-choice Chemotherapy in Pre-treated Patients With Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)
1 other identifier
interventional
129
1 country
40
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2026
Typical duration for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2025
CompletedFirst Posted
Study publicly available on registry
April 22, 2025
CompletedStudy Start
First participant enrolled
February 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
February 11, 2026
February 1, 2026
3 years
April 14, 2025
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival (OS) in patients who received at least one dose of treatment.
Time from date of inclusion to the date of death due to any cause. Time from date of inclusion to the date of death due to any cause. Time from date of inclusion to the date of death due to any cause.
About 4 years
Secondary Outcomes (7)
Safety and tolerability of cemiplimab
About 4 years
Objective Response Rate (ORR)
About 4 years
Duration of Response (DoR)
About 4 years
Disease Control Rate (DCR)
About 4 years
Progression-Free Survival (PFS)
About 4 years
- +2 more secondary outcomes
Study Arms (2)
Arm A : Standard of care chemotherapy
ACTIVE COMPARATORStudy treatment in the arm A is left to the investigator appreciations. This may include immune checkpoint inhibitors, docetaxel, topotecan for primary lung tumors, and FOLFOX, FOLFIRI or alkylating-based chemotherapy in primary digestive tumors.
Arm B : Tarlatamab
EXPERIMENTALTarlatamab 10 mg every 2 weeks
Interventions
Study treatment in the arm A is left to the investigator appreciations. This may include immune checkpoint inhibitors, docetaxel, topotecan for primary lung tumors, and FOLFOX, FOLFIRI or alkylating-based chemotherapy in primary digestive tumors.
Eligibility Criteria
You may qualify if:
- Signed Informed consent:
- Subjects 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 procedures that are not part of normal subject care.
- Subjects 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 (assessed on archived tissue, with possible pre-screening during first-line).
- 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 except subjects with documented Gilbert's syndrome or liver metastasis, who must have AST and ALT ≤ 5 x ULN and a baseline total bilirubin ≤ 3.0 mg/dL.
- 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 for toxicities not considered a safety risk, such as alopecia or vitiligo.
- 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.
- +3 more criteria
You may not qualify if:
- 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 chemotherapy for non-metastatic stage and the initiation of first-line chemotherapy for metastatic/recurrent disease.
- 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:
- Subjects with asymptomatic CNS metastases are eligible if clinically stable for at least 4 weeks and do not require intervention (including use of corticosteroids).
- Subjects 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 anti-epileptic drugs at least 14 days prior to first dose of study treatment
- 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 a curative way with or without chemotherapy and without any evidence of disease \>2 years before randomisation can be included as well.
- 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.
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Angers - CHU
Angers, France
Avignon - CH
Avignon, France
Besançon - CHU
Besançon, France
Boulogne - Ambroise Paré
Boulogne, France
Caen - CHU
Caen, France
Caen - CHU
Caen, France
Tours - CHU
Chambray-lès-Tours, France
Dijon - Centre Georges-François Leclerc
Dijon, France
Dijon - CHU Bocage
Dijon, France
Grenoble - CHU
Grenoble, France
Le Mans - CHG
Le Mans, France
Lille - Centre Oscar Lambret
Lille, France
Limoges - CHU
Limoges, France
Limoges - CHU
Limoges, France
Lyon - Centre Léon Bérard
Lyon, France
Lyon - Hôpital Edouard Herriot
Lyon, France
Lyon - Hôpital Privé Jean Mermoz
Lyon, France
Marseille - APHM
Marseille, France
Marseille - Institut Paoli-Calmettes
Marseille, France
Montpellier - CHU
Montpellier, France
Nice - Centre Antoine Lacassagne
Nice, France
Paris - Curie
Paris, France
Paris - Hôpital Cochin
Paris, France
Paris - Saint-Antoine
Paris, France
Paris - Tenon
Paris, France
Bordeaux - CHU
Pessac, France
Bordeaux - CHU
Pessac, France
Lyon - HCL
Pierre-Bénite, France
Poitiers - CHU
Poitiers, France
Reims - CHU
Reims, France
Rennes - CHU
Rennes, France
Rouen - CHU
Rouen, France
Nantes - Hôpital Laennec
Saint-Herblain, France
Nantes - Institut de Cancérologie de l'Ouest
Saint-Herblain, France
Strasbourg - Nouvel Hôpital Civil
Strasbourg, France
Toulon - CHI
Toulon, France
Toulouse - CHU
Toulouse, France
Tours - CHU
Tours, France
Vandoeuvre-lès-Nancy - Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Villefranche sur Saône - CH
Villefranche-sur-Saône, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2025
First Posted
April 22, 2025
Study Start
February 6, 2026
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
August 1, 2030
Last Updated
February 11, 2026
Record last verified: 2026-02