A clinical study to investigate the efficacy of tarlatamab in people with extensive-stage small cell lung cancer (ES-SCLC) whose cancer has progressed during or after prior treatment and who have a limited health status.

2025-522288-13-00 Protocol ETOP29-25 START-lung Therapeutic exploratory (Phase II) Authorised, recruitment pending

Status Authorised, recruitment pending · 4 EU/EEA countries · 11 sites · Protocol ETOP29-25 START-lung

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Authorised, recruitment pending
Participants planned 50
Countries 4
Sites 11

Patients with pretreated extensive-stage small cell lung cancer (ES-SCLC) and ECOG PS 2

The primary objective of the trial is to assess the clinical efficacy of tarlatamab in terms of 12-month overall survival (OS) rate in patients with ES-SCLC and ECOG PS 2 who have previously received one line of platinum-etoposide doublet chemotherapy with an immune-checkpoint inhibitor and whose disease has progressed…

Key facts

Sponsor
ETOP IBCSG Partners Foundation
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Neoplasms [C04]
Decision date (initial)
2026-04-13
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Amgen Switzerland AG

External identifiers

EU CT number
2025-522288-13-00
ClinicalTrials.gov
NCT07203053

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

The primary objective of the trial is to assess the clinical efficacy of tarlatamab in terms of 12-month overall survival (OS) rate in patients with ES-SCLC and ECOG PS 2 who have previously received one line of platinum-etoposide doublet chemotherapy with an immune-checkpoint inhibitor and whose disease has progressed.

Secondary objectives 1

  1. Secondary objectives include secondary measures of clinical efficacy, including objective response rate (ORR), duration of response (DoR) and progression-free survival (PFS), as well as assessment of the safety and tolerability of treatment with tarlatamab.

Conditions and MedDRA coding

Patients with pretreated extensive-stage small cell lung cancer (ES-SCLC) and ECOG PS 2

VersionLevelCodeTermSystem organ class
21.1 PT 10041067 Small cell lung cancer 100000004864
20.0 LLT 10007096 Cancer of lung 10029104
21.1 PT 10041068 Small cell lung cancer extensive stage 100000004864

Study design 4 periods

#TitleAllocationBlindingRoles blindedArms
1 Screening
Screening procedures and assessments, evaluations to be done within 5 weeks before enrolment.
 Not Applicable None
2 Treatment period
Protocol treatment consists of tarlatamab, administered as an intravenous (i.v.) infusion.
 Not Applicable None Experimental arm: Tarlatamab is administered as an intravenous (i.v.) infusion:
• 1 mg on day 1 (C1D1),
• 10 mg on day 8 (C1D8) and
• 10 mg on day 15 (C1D15),
• then 10 mg every two weeks (Q2W) until disease progression according to RECIST v1.1 criteria, unacceptable toxicity, or patient decision, whichever comes first.
3 End of treatment
At the end of the treatment with tarlatamab, regardless of the reason for stopping treatment, an end of treatment visit is to be scheduled within 30 days of the decision to discontinue treatment with tarlatamab.
 Not Applicable None
4 Follow-up after disease progression
Follow-up visits after disease progression have to be done every 12 weeks (±2 weeks). The following should be documented: Post-progression therapies / procedures Survival
 Not Applicable None

Regulatory references

Plan to share IPD
No
EU CT numberTitleSponsor
2024-520050-38-00 A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in combination with Durvalumab, Carboplatin and Etoposide versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312) Amgen Inc.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

  1. Histologically or cytologically confirmed ES-SCLC
  2. Previous treatment with only one line of platinum-etoposide doublet chemotherapy with immune-checkpoint inhibition for SCLC
  3. Progressive disease on or after the first-line treatment for SCLC
  4. ECOG Performance Status 2
  5. Age ≥18 years
  6. Adequate organ function
  7. Negative pregnancy test for female participants of childbearing potential
  8. Written Informed Consent signed before any trial-related intervention

Exclusion criteria 8

  1. Symptomatic CNS metastases
  2. Diagnosis or evidence of leptomeningeal disease or spinal cord compression
  3. Prior history of immune-related recurrent pneumonitis (grade ≥2)) or severe immune-mediated adverse events
  4. Evidence of interstitial lung disease or active, non-infectious pneumonitis
  5. Active autoimmune disease
  6. History of solid organ transplantation
  7. Presence or history of an uncontrolled viral infection
  8. History of other malignancy within the past 2 years

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Overall survival rate at 12 months (12-month OS)

Secondary endpoints 5

  1. Objective response rate (ORR) according to RECIST v1.1
  2. Duration of response (DoR)
  3. Disease control rate (DCR)
  4. Progression-free survival (PFS) according to RECIST v1.1
  5. Incidence, nature, and severity of adverse events according to CTCAE v5, except for CRS and ICANS, that are graded according to the ASTCT criteria and TLS that are graded according to the Cairo-Bishop classification

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Tarlatamab

PRD10282194 · Product

Active substance
Tarlatamab
Substance synonyms
AMG 757
Pharmaceutical form
SOLUTION FOR INJECTION/INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
10 mg milligram(s)
Max total dose
910 mg milligram(s)
Max treatment duration
182 Week(s)
Authorisation status
Not Authorised
MA holder
AMGEN INC
Paediatric formulation
No
Orphan designation
No

Tarlatamab

PRD10282188 · Product

Active substance
Tarlatamab
Pharmaceutical form
POWDER FOR SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
10 mg milligram(s)
Max total dose
910 mg milligram(s)
Max treatment duration
182 Week(s)
Authorisation status
Not Authorised
MA holder
AMGEN INC
Paediatric formulation
No
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

ETOP IBCSG Partners Foundation

10 Total trials 3 Recruiting 6 Ended
Academic / Non-commercial
Sponsor organisation
ETOP IBCSG Partners Foundation
Address
Effingerstrasse 33
City
Bern
Postcode
3008
Country
Switzerland

Scientific contact point

Organisation
ETOP IBCSG Partners Foundation
Contact name
ETOP IBCSG Partners Foundation Regulatory Office

Public contact point

Organisation
ETOP IBCSG Partners Foundation
Contact name
ETOP IBCSG Partners Foundation Regulatory Office

Third parties 4

OrganisationCity, countryDuties
Centre Hospitalier Universitaire Vaudois
ORG-100025536
 Lausanne, Switzerland Laboratory analysis
Frontier Science Foundation-Hellas
ORG-100047506
 Athens, Greece Code 10, Code 11
Acceler8 Clinical Research Limited
ORL-000017294
 Knutsford, United Kingdom On site monitoring, Code 12, Code 5
Fundacion GECP
ORG-100043327
 Barcelona, Spain On site monitoring, Code 12, Code 2

Locations

4 EU/EEA countries · 11 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Authorised, recruitment pending 10 3
Greece Authorised, recruitment pending 10 1
Italy Authorised, recruitment pending 10 2
Spain Authorised, recruitment pending 10 5
Rest of world
Switzerland
 — 10 —

Investigational sites

France

3 sites · Authorised, recruitment pending
Centre Hospitalier Regional De Marseille
Service Oncologie Multidisciplinaire et Innovations Thérapeutiques, 265 Chemin Des Bourrely, 13015, Marseille
Centre Leon Berard
Pulmology, 28 Rue Laennec, 69008, Lyon
Institut Bergonie
Oncology, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux

Greece

1 site · Authorised, recruitment pending
Henry Dunant Hospital Center
4th Oncology Department and Clinical Trials Unit, 107 Mesogeion Avenue, 115 26, Athens

Italy

2 sites · Authorised, recruitment pending
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Thoracic oncology, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliera Di Perugia
Medical oncology, Via Gerardo Dottori 1, 06132, Perugia

Spain

5 sites · Authorised, recruitment pending
Hospital General Universitario Dr. Balmis
Medical Oncology, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Universitario Puerta De Hierro De Majadahonda
Medical Oncology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Ico L'hospitalet Hospital Duran I Reynals
Medical Oncology, Avinguda de la Granvia de l'hospitalet 199-203, 08908, Barcelona
Hospital De La Santa Creu I Sant Pau
Medical Oncology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitari Vall D Hebron
Medical Oncology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol Appendix1_2025-522288-13_Redacted 1
Protocol (for publication) D1_Protocol_2025-522288-13_Redacted 1.1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1.2
Recruitment arrangements (for publication) K1_Recruitment arrangements 1.1
Recruitment arrangements (for publication) K1_recrutiment arrangements 1
Subject information and informed consent form (for publication) L1_ICF Master_FR 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF data processing_clean 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF Master_EL 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF Master_IT 1.3
Subject information and informed consent form (for publication) L1_SIS Master_Appendix_FR 1.2
Subject information and informed consent form (for publication) L1_SIS Master_FR 1.2
Subject information and informed consent form (for publication) L1_SIS_and ICF Master_ES 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient Card_EL 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_Patient Card_ES 1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient Card_FR 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient Card_IT 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_EN_2025-522288-13 1.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_ES_2025-522288-13 1.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_FR_2025-522288-13 1.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_GR_2025-522288-13 1.1
Synopsis of the protocol (for publication) D1_Protocol synopsis_IT_2025-522288-13 1.1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-12-18 Spain Acceptable
2026-04-08
 2026-04-08

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