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Neuroendocrine CarcinomaPhase 3TARLANECNCT06937905

Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)

A Phase 3 study testing Tarlatamab in people with Neuroendocrine Carcinoma, run by Intergroupe Francophone de Cancerologie Thoracique at 40 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Carcinoma
What is being tested?
Tarlatamab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
40 sitesFrance
Study dates
6 Feb 2026to 1 Aug 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 18Show fewer
  • 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.
  • 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 agree to continue using such precautions for 7 months after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. They must also refrain from egg cell donation for 7 months after the final dose of investigational product.
  • 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.

Who cannot join

  • 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:
Show all 30Show fewer
  • 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.
  • 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 parenteral antibiotic therapy. Upon completion of parental antibiotic therapy and resolution of symptoms, the patient may be considered eligible under the infection criterion.
  • 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 or 4) immune mediated toxicity from other immune therapy.
  • 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 thoracic drain for pleural fluid collection).
  • 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 respiratory syndrome coronavirus 2 (SARS-CoV-2) should be avoided during selection, at least 14 days before the first day of treatment. Live, non-replicating smallpox vaccines (such as Jynneos) against monkeypox infection are permitted during the study (except during cycle 1) in accordance with the center's standard of care and internal recommendations.
  • 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.

Trial locations and contacts

40 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Contact IFCT contact

+33 1.56.81.10.45

contact@ifct.fr

40 sites in 1 country

France40 sites, 40 recruiting

  • Angers - CHU

    Angers

    Guillaume ROQUIN, +33156811045, contact@ifct.fr

    Guillaume ROQUIN

    Recruiting

  • Avignon - CH

    Avignon

    Malek ZOGHLAMI, +33 1.56.81.10.45, contact@ifct.fr

    Malek ZOGHLAMI

    Recruiting

  • Besançon - CHU

    Besançon

    Hamadi ALMOTLAK, +331.56.81.10.45, contact@ifct.fr

    Hamadi ALMOTLAK

    Recruiting

  • Boulogne - Ambroise Paré

    Boulogne

    Etienne GIROUX LEPRIEUR

    Etienne GIROUX LEPRIEUR

    Recruiting

  • Caen - CHU

    Caen

    Jeannick MADELAINE, +33 1.56.81.10.45, contact@ifct.fr

    Jeannick MADELAINE

    Recruiting

  • Caen - CHU

    Caen

    Karine BOUHIER-LEPORRIER, +33 1.56.81.10.45, contact@ifct.fr

    Karine BOUHIER-LEPORRIER

    Recruiting

  • Tours - CHU

    Chambray-lès-Tours

    Morgane CAULET, +33 1.56.81.10.45, contact@ifct.fr

    Morgane CAULET

    Recruiting

  • Dijon - Centre Georges-François Leclerc

    Dijon

    François GHIRINGHELI, +33 1.56.81.10.45, contact@ifct.fr

    François GHIRINGHELI

    Recruiting

  • Dijon - CHU Bocage

    Dijon

    Côme LEPAGE, +33 1.56.81.10.45, contact@ifct.fr

    Côme LEPAGE

    Recruiting

  • Grenoble - CHU

    Grenoble

    Denis MORO-SIBILOT, 33 1.56.81.10.45, contact@ifct.fr

    Denis MORO-SIBILOT

    Recruiting

  • Le Mans - CHG

    Le Mans

    Camille GUGUEN, +33 1.56.81.10.45, contact@ifct.fr

    Camille GUGUEN

    Recruiting

  • Lille - Centre Oscar Lambret

    Lille

    Elisabeth GAYE, +33 1.56.81.10.45, contact@ifct.fr

    Elisabeth GAYE

    Recruiting

  • Limoges - CHU

    Limoges

    homas EGENOD, +33 1.56.81.10.45, contact@ifct.fr

    homas EGENOD

    Recruiting

  • Limoges - CHU

    Limoges

    rédéric THUILLIER, +33 1.56.81.10.45, contact@ifct.fr

    rédéric THUILLIER

    Recruiting

  • Lyon - Centre Léon Bérard

    Lyon

    Aurélie SWALDUZ, +33 1.56.81.10.45, contact@ifct.fr

    Aurélie SWALDUZ

    Recruiting

  • Lyon - Hôpital Edouard Herriot

    Lyon

    Thomas WALTER, +33 1.56.81.10.45, contact@ifct.fr

    Thomas WALTER

    Recruiting

  • Lyon - Hôpital Privé Jean Mermoz

    Lyon

    Jérôme DESRAME, +33 1.56.81.10.45, contact@ifct.fr

    Jérôme DESRAME

    Recruiting

  • Marseille - APHM

    Marseille

    Laurent GREILLIER, +33 1.56.81.10.45, contact@ifct.fr

    Laurent GREILLIER

    Recruiting

  • Marseille - Institut Paoli-Calmettes

    Marseille

    Patricia NICCOLI, +33 1.56.81.10.45, contact@ifct.fr

    Patricia NICCOLI

    Recruiting

  • Montpellier - CHU

    Montpellier

    Patricia BARRE, +33 1.56.81.10.45, contact@ifct.fr

    Patricia BARRE

    Recruiting

  • Nice - Centre Antoine Lacassagne

    Nice

    Claire JARAUDIAS, +33 1.56.81.10.45, contact@ifct.fr

    Claire JARAUDIAS

    Recruiting

  • Paris - Curie

    Paris

    Nicolas GIRARD

    Nicolas GIRARD

    Recruiting

  • Paris - Hôpital Cochin

    Paris

    Anne PELLAT, +33 1.56.81.10.45, contact@ifct.fr

    Anne PELLAT

    Recruiting

  • Paris - Saint-Antoine

    Paris

    Pauline AFCHAIN, +33 1.56.81.10.45, contact@ifct.fr

    Pauline AFCHAIN

    Recruiting

  • Paris - Tenon

    Paris

    Anthony CANELLAS, +33 1.56.81.10.45, contact@ifct.fr

    Anthony CANELLAS

    Recruiting

  • Bordeaux - CHU

    Pessac

    Denis SMITH, +33 1.56.81.10.45, contact@ifct.fr

    Denis SMITH

    Recruiting

  • Bordeaux - CHU

    Pessac

    Maéva ZYSMAN, +33 1.56.81.10.45, contact@ifct.fr

    Maéva ZYSMAN

    Recruiting

  • Lyon - HCL

    Pierre-Bénite

    Sébastien COURAUD, +33 1.56.81.10.45, contact@ifct.fr

    Sébastien COURAUD

    Recruiting

  • Poitiers - CHU

    Poitiers

    Aurélie FERRU, +33 1.56.81.10.45, contact@ifct.fr

    Aurélie FERRU

    Recruiting

  • Reims - CHU

    Reims

    Maxime DEWOLF, +33 1.56.81.10.45, contact@ifct.fr

    Maxime DEWOLF

    Recruiting

  • Rennes - CHU

    Rennes

    Charles RICORDEL, +33 1.56.81.10.45, contact@ifct.fr

    Charles RICORDEL

    Recruiting

  • Rouen - CHU

    Rouen

    Frédéric DI FIORE, +33 1.56.81.10.45, contact@ifct.fr

    Frédéric DI FIORE

    Recruiting

  • Nantes - Hôpital Laennec

    Saint-Herblain

    Alexandre LUGAT, +33 1.56.81.10.45, contact@ifct.fr

    Alexandre LUGAT

    Recruiting

  • Nantes - Institut de Cancérologie de l'Ouest

    Saint-Herblain

    Hélène SENELLART, +33 1.56.81.10.45, contact@ifct.fr

    Hélène SENELLART

    Recruiting

  • Strasbourg - Nouvel Hôpital Civil

    Strasbourg

    Guillaume PAMART, +33 1.56.81.10.45, contact@ifct.fr

    Guillaume PAMART

    Recruiting

  • Toulon - CHI

    Toulon

    Clarisse AUDIGIER-VALETTE, +33 1.56.81.10.45, contact@ifct.fr

    Clarisse AUDIGIER-VALETTE

    Recruiting

  • Toulouse - CHU

    Toulouse

    Julien MAZIERES, +33 1.56.81.10.45, contact@ifct.fr

    Julien MAZIERES

    Recruiting

  • Tours - CHU

    Tours

    Delphine CARMIER, +33 1.56.81.10.45, contact@ifct.fr

    Delphine CARMIER

    Recruiting

  • Vandoeuvre-lès-Nancy - Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy

    Christelle CLEMENT-DUCHENE, +33 1.56.81.10.45, contact@ifct.fr

    Christelle CLEMENT-DUCHENE

    Recruiting

  • Villefranche sur Saône - CH

    Villefranche-sur-Saône

    Luc ODIER, +33 1.56.81.10.45, contact@ifct.fr

    Luc ODIER

    Recruiting

Other trials in France

About this study

Official title: 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)

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.

Being tested
Standard of Care Chemotherapy, Tarlatamab
Keywords
Neuroendocrine Carcinoma of Lung (Large cells), Gastroenteropancreatic Neuroendocrine Carcinoma, IFCT, FFCD, GERCOR, GCO
Medical subject headings
Carcinoma, Neuroendocrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard of Care ChemotherapyDrug

    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.

  • TarlatamabDrug

    Tarlatamab 10 mg every 2 weeks

Study groups in NCT06937905
Study groupRoleWhat they receive
Arm A : Standard of care chemotherapyActive 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.
Receives: Drug: Standard of Care Chemotherapy
Arm B : TarlatamabExperimentalTarlatamab 10 mg every 2 weeks
Receives: Drug: Tarlatamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: About 4 years

Secondary outcomes (7)

  1. Safety and tolerability of cemiplimab

    Incidence, nature, and severity of treatment-related adverse events/treatment-emergent adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)except CRS and ICANS events graded using ASTCT 2019

    Measured: About 4 years

  2. Objective Response Rate (ORR)

    Proportion of patients who have achieved a best overall response of complete response (CR) or partial response (PR) or stable disease (SD)

    Measured: About 4 years

  3. Duration of Response (DoR)

    Time from the date of the first response (CR or PR) to the earliest date of disease progression

    Measured: About 4 years

  4. Disease Control Rate (DCR)

    Proportion of patients who have achieved a best overall response of complete response (CR) or partial response (PR) or stable disease (SD)

    Measured: About 4 years

  5. Progression-Free Survival (PFS)

    Time from randomization to progression or death.

    Measured: About 4 years

  6. Overall survival (OS)

    Time from date of inclusion to the date of death due to any cause.

    Measured: About 4 years

  7. To evaluate the quality of life of patients with questionnaire EORTC Quality of Life Questionnaire - Core C30 (QLQ-C30)

    Time to symptom deterioration will be defined as the time from ranodmization until the date of first symptom deterioration.

    The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core Questionnaire C30 (EORTC QLQ-C30) is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients.

    Scale : Not at all / A little / Quite a bit / Very much

    Measured: About 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2025
  2. Study start6 Feb 2026
  3. Primary completion1 Feb 2029 (estimated)
  4. Study completion1 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
129 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06937905
Sponsor's protocol ID
GCO-003
Acronym
TARLANEC
Status last verified
Feb 2026
First submitted
14 Apr 2025
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tarlatamab in people with Neuroendocrine Carcinoma, run by Intergroupe Francophone de Cancerologie Thoracique at 40 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Contact IFCT (+33 1.56.81.10.45, contact@ifct.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) in patients who received at least one dose of treatment. (time frame: About 4 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06937905.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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