Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Temporarily halted
Participants planned
200
Countries
6
Sites
18
Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Key facts
- Sponsor
- Amgen Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 31 Oct 2025 → ongoing
- Decision date (initial)
- 2025-09-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-515903-21-00
- WHO UTN
- U1111-1316-8805
- ClinicalTrials.gov
- NCT06898957
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Extensive Stage Small Cell Lung Cancer (ES-SCLC)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10041068 | Small cell lung cancer extensive stage | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amgen Inc.
- Sponsor organisation
- Amgen Inc.
- Address
- 1 Amgen Center Drive
- City
- Thousand Oaks
- Postcode
- 91320-1730
- Country
- United States
Scientific contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Public contact point
- Organisation
- Amgen Inc.
- Contact name
- Medical Information
Locations
6 EU/EEA countries · 18 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Temporarily halted | 10 | 4 |
| Germany | Temporarily halted | 3 | 1 |
| Greece | Temporarily halted | 9 | 4 |
| Hungary | Temporarily halted | 5 | 2 |
| Italy | Temporarily halted | 8 | 3 |
| Spain | Temporarily halted | 12 | 4 |
| Rest of world
Korea, Republic of, China, United States, Canada
|
— | 153 | — |
Investigational sites
Institut Bergonie
Oncologie medicale, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Oncopole Claudius Regaud
Service Oncologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Leon Berard
Oncologie medicale, 28 Rue Laennec, 69008, Lyon
Institut Gustave Roussy
Departement Interdisciplinaire d Organisation des Parcours Patients, 114 Rue Edouard Vaillant, 94800, Villejuif
Universitaetsklinikum Essen AöR
Universitätsklinikum Essen, Innere Klinik (Tumorforschung), Hufelandstrasse 55, Holsterhausen, Essen
Alexandra Hospital
Oncology Department, Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
Athens Medical Center S.A.
Oncology Department, Pylea, Asklipiou 10, Thessaloniki
Henry Dunant Hospital Center
4th Oncology Department and Clinical Trials Unit, 107 Mesogeion Avenue, 115 26, Athens
Athens Medical Center S.A.
4th Department of Medical Oncology, Pylea, Asklipiou 10, Thessaloniki
Clinexpert Kft.
NA, Dozsa Gyorgy Utca 15, 3200, Gyongyos
Semmelweis University
Belgyogyaszati es Onkologiai Klinika, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Unita Operativa Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
ASST Grande Ospedale Metropolitano Niguarda
Dipartimento Ematologia Oncologia e Medicina molecolare, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Day Hospital Oncologico, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Hospital Universitario Puerta De Hierro De Majadahonda
Oncology, Calle De Manuel De Falla 1, 28222, Majadahonda
Hospital De La Santa Creu I Sant Pau
Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitari Vall D Hebron
Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-11-24 | 2025-12-30 | 2026-03-27 | ||
| Germany | 2025-12-16 | 2026-01-29 | 2026-03-27 | ||
| Greece | 2025-11-04 | 2025-12-08 | 2026-03-27 | ||
| Hungary | 2025-10-31 | 2025-11-26 | 2026-03-27 | ||
| Italy | 2025-10-31 | 2025-11-27 | 2026-03-27 | ||
| Spain | 2025-11-06 | 2025-12-02 | 2026-03-27 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 6 · Art. 38 CTR
Temporary halt TH-126851
- Halt date
- 2026-03-27
- Member states concerned
- Hungary
- Publication date
- 2026-04-01
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- The primary reason for implementing the Temporary Halt is a safety related decision.
The temporary halt is applicable for Halt screening activities, Halt screening and enrollment activities and Screen fail subjects in screening. Subjects on treatment may continue treatment, provided requirements in the DIL are met.
This temporary halt is related to an USM which has been submitted on 31 March 2026 (Business key: US-126559, Sponsor internal identifier SIMS ID: 27146) - Follow-up measures
- At this time, Amgen has not determined whether there is a causal relationship between
tarlatamab and YL201 and the fatal case of pneumonitis described above. A comprehensive
safety assessment is currently in progress. Based on the details of this event, Amgen will take
the following actions:
- Temporary halt of all screening and enrollment activities on study 20240124 with immediate
effect. In the interim, participants currently receiving study investigational products
(tarlatamab and/or YL201) may continue treatment per protocol at the discretion of the
principal investigator, provided the investigator determines that the potential benefit
outweighs the potential risk. The risks and benefits of continuing treatment must be clearly
discussed with the participant and appropriately documented before administration of the
next dose of investigational products.
- Amgen will perform a comprehensive safety evaluation of the pneumonitis event, including
review of individual case safety reports, aggregate safety data from Study 20240124, and
other relevant available information, to assess whether there may be a causal relationship
between tarlatamab and YL201, and pneumonitis. The outcome of this assessment,
together with any additional actions deemed necessary, including but not limited to updates
to the informed consent form, will be communicated to investigators in a follow-up letter.
- A protocol amendment is not required at this time given that the protocol includes
appropriate management guidelines for pneumonitis. - Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-126852
- Halt date
- 2026-03-27
- Member states concerned
- Greece
- Publication date
- 2026-04-01
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- The primary reason for implementing the Temporary Halt is a safety related decision.
The temporary halt is applicable for Halt screening activities, Halt screening and enrollment activities and Screen fail subjects in screening. Subjects on treatment may continue treatment, provided requirements in the DIL are met.
This temporary halt is related to an USM which has been submitted on 31 March 2026 (Business key: US-126559, Sponsor internal identifier SIMS ID: 27146) - Follow-up measures
- At this time, Amgen has not determined whether there is a causal relationship between
tarlatamab and YL201 and the fatal case of pneumonitis described above. A comprehensive
safety assessment is currently in progress. Based on the details of this event, Amgen will take
the following actions:
- Temporary halt of all screening and enrollment activities on study 20240124 with immediate
effect. In the interim, participants currently receiving study investigational products
(tarlatamab and/or YL201) may continue treatment per protocol at the discretion of the
principal investigator, provided the investigator determines that the potential benefit
outweighs the potential risk. The risks and benefits of continuing treatment must be clearly
discussed with the participant and appropriately documented before administration of the
next dose of investigational products.
- Amgen will perform a comprehensive safety evaluation of the pneumonitis event, including
review of individual case safety reports, aggregate safety data from Study 20240124, and
other relevant available information, to assess whether there may be a causal relationship
between tarlatamab and YL201, and pneumonitis. The outcome of this assessment,
together with any additional actions deemed necessary, including but not limited to updates
to the informed consent form, will be communicated to investigators in a follow-up letter.
- A protocol amendment is not required at this time given that the protocol includes
appropriate management guidelines for pneumonitis. - Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-126853
- Halt date
- 2026-03-27
- Member states concerned
- France
- Publication date
- 2026-04-01
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- The primary reason for implementing the Temporary Halt is a safety related decision.
The temporary halt is applicable for Halt screening activities, Halt screening and enrollment activities and Screen fail subjects in screening. Subjects on treatment may continue treatment, provided requirements in the DIL are met.
This temporary halt is related to an USM which has been submitted on 31 March 2026 (Business key: US-126559, Sponsor internal identifier SIMS ID: 27146) No subjects are currently receiving treatment in France - Follow-up measures
- At this time, Amgen has not determined whether there is a causal relationship between
tarlatamab and YL201 and the fatal case of pneumonitis described above. A comprehensive
safety assessment is currently in progress. Based on the details of this event, Amgen will take
the following actions:
- Temporary halt of all screening and enrollment activities on study 20240124 with immediate
effect. In the interim, participants currently receiving study investigational products
(tarlatamab and/or YL201) may continue treatment per protocol at the discretion of the
principal investigator, provided the investigator determines that the potential benefit
outweighs the potential risk. The risks and benefits of continuing treatment must be clearly
discussed with the participant and appropriately documented before administration of the
next dose of investigational products.
- Amgen will perform a comprehensive safety evaluation of the pneumonitis event, including
review of individual case safety reports, aggregate safety data from Study 20240124, and
other relevant available information, to assess whether there may be a causal relationship
between tarlatamab and YL201, and pneumonitis. The outcome of this assessment,
together with any additional actions deemed necessary, including but not limited to updates
to the informed consent form, will be communicated to investigators in a follow-up letter.
- A protocol amendment is not required at this time given that the protocol includes
appropriate management guidelines for pneumonitis. - Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-126844
- Halt date
- 2026-03-27
- Member states concerned
- Germany
- Publication date
- 2026-04-01
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- The primary reason for implementing the Temporary Halt is a safety related decision.
The temporary halt is applicable for Halt screening activities, Halt screening and enrollment activities and Screen fail subjects in screening. Subjects on treatment may continue treatment, provided requirements in the DIL are met.
This temporary halt is related to an USM which has been submitted on 31 March 2026 (Business key: US-126559, Sponsor internal identifier SIMS ID: 27146) - Follow-up measures
- At this time, Amgen has not determined whether there is a causal relationship between
tarlatamab and YL201 and the fatal case of pneumonitis described above. A comprehensive
safety assessment is currently in progress. Based on the details of this event, Amgen will take
the following actions:
- Temporary halt of all screening and enrollment activities on study 20240124 with immediate
effect. In the interim, participants currently receiving study investigational products
(tarlatamab and/or YL201) may continue treatment per protocol at the discretion of the
principal investigator, provided the investigator determines that the potential benefit
outweighs the potential risk. The risks and benefits of continuing treatment must be clearly
discussed with the participant and appropriately documented before administration of the
next dose of investigational products.
- Amgen will perform a comprehensive safety evaluation of the pneumonitis event, including
review of individual case safety reports, aggregate safety data from Study 20240124, and
other relevant available information, to assess whether there may be a causal relationship
between tarlatamab and YL201, and pneumonitis. The outcome of this assessment,
together with any additional actions deemed necessary, including but not limited to updates
to the informed consent form, will be communicated to investigators in a follow-up letter.
- A protocol amendment is not required at this time given that the protocol includes
appropriate management guidelines for pneumonitis. - Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-126848
- Halt date
- 2026-03-27
- Member states concerned
- Spain
- Publication date
- 2026-04-01
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- The primary reason for implementing the Temporary Halt is a safety related decision.
The temporary halt is applicable for Halt screening activities, Halt screening and enrollment activities and Screen fail subjects in screening. Subjects on treatment may continue treatment, provided requirements in the DIL are met.
This temporary halt is related to an USM which has been submitted on 31 March 2026 (Business key: US-126559, Sponsor internal identifier SIMS ID: 27146) - Follow-up measures
- At this time, Amgen has not determined whether there is a causal relationship between
tarlatamab and YL201 and the fatal case of pneumonitis described above. A comprehensive
safety assessment is currently in progress. Based on the details of this event, Amgen will take
the following actions:
- Temporary halt of all screening and enrollment activities on study 20240124 with immediate
effect. In the interim, participants currently receiving study investigational products
(tarlatamab and/or YL201) may continue treatment per protocol at the discretion of the
principal investigator, provided the investigator determines that the potential benefit
outweighs the potential risk. The risks and benefits of continuing treatment must be clearly
discussed with the participant and appropriately documented before administration of the
next dose of investigational products.
- Amgen will perform a comprehensive safety evaluation of the pneumonitis event, including
review of individual case safety reports, aggregate safety data from Study 20240124, and
other relevant available information, to assess whether there may be a causal relationship
between tarlatamab and YL201, and pneumonitis. The outcome of this assessment,
together with any additional actions deemed necessary, including but not limited to updates
to the informed consent form, will be communicated to investigators in a follow-up letter.
- A protocol amendment is not required at this time given that the protocol includes
appropriate management guidelines for pneumonitis. - Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-126849
- Halt date
- 2026-03-27
- Member states concerned
- Italy
- Publication date
- 2026-04-01
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- The primary reason for implementing the Temporary Halt is a safety related decision.
The temporary halt is applicable for Halt screening activities, Halt screening and enrollment activities and Screen fail subjects in screening. Subjects on treatment may continue treatment, provided requirements in the DIL are met.
This temporary halt is related to an USM which has been submitted on 31 March 2026 (Business key: US-126559, Sponsor internal identifier SIMS ID: 27146) - Follow-up measures
- At this time, Amgen has not determined whether there is a causal relationship between
tarlatamab and YL201 and the fatal case of pneumonitis described above. A comprehensive
safety assessment is currently in progress. Based on the details of this event, Amgen will take
the following actions:
- Temporary halt of all screening and enrollment activities on study 20240124 with immediate
effect. In the interim, participants currently receiving study investigational products
(tarlatamab and/or YL201) may continue treatment per protocol at the discretion of the
principal investigator, provided the investigator determines that the potential benefit
outweighs the potential risk. The risks and benefits of continuing treatment must be clearly
discussed with the participant and appropriately documented before administration of the
next dose of investigational products.
- Amgen will perform a comprehensive safety evaluation of the pneumonitis event, including
review of individual case safety reports, aggregate safety data from Study 20240124, and
other relevant available information, to assess whether there may be a causal relationship
between tarlatamab and YL201, and pneumonitis. The outcome of this assessment,
together with any additional actions deemed necessary, including but not limited to updates
to the informed consent form, will be communicated to investigators in a follow-up letter.
- A protocol amendment is not required at this time given that the protocol includes
appropriate management guidelines for pneumonitis. - Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-06 | Italy | Acceptable 2025-09-30
|
2025-09-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-06 | Acceptable 2025-09-30
|
2025-10-06 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-27 | Italy | Acceptable 2025-12-23
|
2025-12-23 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-02 | Acceptable | 2026-04-03 |