Actively Recruiting
Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)
Led by Intergroupe Francophone de Cancerologie Thoracique · Updated on 2026-02-11
129
Participants Needed
40
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Age 18 years or older
- WHO performance status 0 or 1
- Life expectancy greater than 12 weeks
- Histologically confirmed poorly differentiated neuroendocrine carcinoma (large cell lung or gastroenteropancreatic)
- DLL3 expression in at least 1% of tumor cells
- Tumor progression after one platinum-based therapy
- Unresectable locally advanced or metastatic disease
- At least one measurable tumor lesion
- Adequate organ function including kidney, blood counts, liver enzymes, and bilirubin
- Full recovery from prior treatment toxicities to baseline or grade 0-1 (except non-safety risks)
- Availability of tumor material for central review and research
- No unstable systemic disease or conditions interfering with study compliance
- Females of childbearing potential must use effective contraception starting 28 days before and continuing 7 months after treatment
- Men sexually active with women of childbearing potential must use contraception for 6 months after last dose
- Patient covered by national health insurance
You will not qualify if you...
- Well-differentiated neuroendocrine tumors (NET G1, G2, G3) or typical/atypical carcinoid tumors
- Prior treatment targeting DLL3
- More than one prior systemic therapy in metastatic setting
- Small cell lung NEC except minor (<30%) component in mixed tumors
- Known EGFR, ALK, or ROS1 mutations in lung NEC
- Untreated or symptomatic brain metastases; treated brain metastases must meet stability criteria
- Leptomeningeal metastasis
- Recent other malignancies except certain treated cancers or skin cancers
- Major surgery within 28 days before study treatment
- Recent myocardial infarction or symptomatic heart failure within 12 months
- Recent arterial thrombosis within 12 months
- Active systemic infection requiring intravenous antibiotics
- Known allergy to study treatments
- History of primary immunodeficiency or recent immunosuppressive therapy
- Immune-related severe adverse events or active immune disorders under immuno-oncology treatment
- Presence of indwelling catheters or drains
- Known acute or chronic hepatitis B or C infection
- Known HIV infection
- Pregnant or breastfeeding women or planning pregnancy during study and 7 months after last dose
- Males unwilling to avoid sperm donation during study and 6 months after last dose
- Recent vaccination with live or attenuated vaccines
- Active autoimmune disease requiring systemic therapy in last 2 years
- Other severe uncontrolled medical conditions interfering with study participation
AI-Screening
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Trial Site Locations
Total: 40 locations
1
Angers - CHU
Angers, France
Actively Recruiting
2
Avignon - CH
Avignon, France
Actively Recruiting
3
Besançon - CHU
Besançon, France
Actively Recruiting
4
Boulogne - Ambroise Paré
Boulogne, France
Actively Recruiting
5
Caen - CHU
Caen, France
Actively Recruiting
6
Caen - CHU
Caen, France
Actively Recruiting
7
Tours - CHU
Chambray-lès-Tours, France
Actively Recruiting
8
Dijon - Centre Georges-François Leclerc
Dijon, France
Actively Recruiting
9
Dijon - CHU Bocage
Dijon, France
Actively Recruiting
10
Grenoble - CHU
Grenoble, France
Actively Recruiting
11
Le Mans - CHG
Le Mans, France
Actively Recruiting
12
Lille - Centre Oscar Lambret
Lille, France
Actively Recruiting
13
Limoges - CHU
Limoges, France
Actively Recruiting
14
Limoges - CHU
Limoges, France
Actively Recruiting
15
Lyon - Centre Léon Bérard
Lyon, France
Actively Recruiting
16
Lyon - Hôpital Edouard Herriot
Lyon, France
Actively Recruiting
17
Lyon - Hôpital Privé Jean Mermoz
Lyon, France
Actively Recruiting
18
Marseille - APHM
Marseille, France
Actively Recruiting
19
Marseille - Institut Paoli-Calmettes
Marseille, France
Actively Recruiting
20
Montpellier - CHU
Montpellier, France
Actively Recruiting
21
Nice - Centre Antoine Lacassagne
Nice, France
Actively Recruiting
22
Paris - Curie
Paris, France
Actively Recruiting
23
Paris - Hôpital Cochin
Paris, France
Actively Recruiting
24
Paris - Saint-Antoine
Paris, France
Actively Recruiting
25
Paris - Tenon
Paris, France
Actively Recruiting
26
Bordeaux - CHU
Pessac, France
Actively Recruiting
27
Bordeaux - CHU
Pessac, France
Actively Recruiting
28
Lyon - HCL
Pierre-Bénite, France
Actively Recruiting
29
Poitiers - CHU
Poitiers, France
Actively Recruiting
30
Reims - CHU
Reims, France
Actively Recruiting
31
Rennes - CHU
Rennes, France
Actively Recruiting
32
Rouen - CHU
Rouen, France
Actively Recruiting
33
Nantes - Hôpital Laennec
Saint-Herblain, France
Actively Recruiting
34
Nantes - Institut de Cancérologie de l'Ouest
Saint-Herblain, France
Actively Recruiting
35
Strasbourg - Nouvel Hôpital Civil
Strasbourg, France
Actively Recruiting
36
Toulon - CHI
Toulon, France
Actively Recruiting
37
Toulouse - CHU
Toulouse, France
Actively Recruiting
38
Tours - CHU
Tours, France
Actively Recruiting
39
Vandoeuvre-lès-Nancy - Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Actively Recruiting
40
Villefranche sur Saône - CH
Villefranche-sur-Saône, France
Actively Recruiting
Research Team
C
Contact IFCT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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