Actively Recruiting
Study of Tarlatamab as Maintenance Treatment After Chemo-radiotherapy for Limited Stage SCLC Patients
Led by Fundación GECP · Updated on 2026-05-05
37
Participants Needed
20
Research Sites
209 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, phase II, exploratory and multi-centre clinical trial. 37 Limited stage SCLC patients not eligible for concurrent chemo-radiotherapy will be enroll. Patients will be enrolled in the trial after receiving sequential chemo-radiotherapy, if there is no progression disease, patients will be treated with maintenance Tarlatamab. Patients will receive maintenance with Tarlatamab IV until disease progression unacceptable toxicity, patient or physician decision to discontinue or death. The primary objective is to evaluate the Progression free survival (PFS). Patient accrual is expected to be completed within 2 years. Treatment and follow-up are expected to extend the study duration to a total of 5 years. Patients will be followed for 2 years after enrollment. The study will end once survival follow-up has concluded.
CONDITIONS
Official Title
Study of Tarlatamab as Maintenance Treatment After Chemo-radiotherapy for Limited Stage SCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed new diagnosis of limited-stage small-cell lung cancer (LS-SCLC) by histology or cytology from brushing, washing, or needle aspiration
- Treated with sequential chemo-radiotherapy or chemotherapy alone
- At least one lesion measurable or non-measurable per RECIST 1.1
- Completed chemo-radiation or chemotherapy alone without disease progression per RECIST v1.1
- Male or female aged 18 years or older at informed consent
- Life expectancy of at least 3 months from study start
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days before first study dose
- Chemo-radiotherapy toxicities resolved to grade 1 or less unless otherwise specified
- No clinically significant electrocardiogram (ECG) abnormalities
- Normal pulmonary function without need for oxygen supplementation
- Voluntarily agreed to participate with written informed consent
- Adequate hematological and biochemistry organ function
You will not qualify if you...
- Expected to require other radiation therapy for LS-SCLC as concurrent radiotherapy
- Extensive-stage SCLC or previous diagnosis of transformed non-small cell lung cancer; mixed tumors not eligible
- Known or active neurologic paraneoplastic syndrome of autoimmune nature
- Major surgery within 4 weeks before first study dose
- Participation in another investigational study or use of investigational device within 4 weeks before first study dose
- History of second malignancy other than SCLC unless cured with no evidence for at least 3 years
- Uncontrolled active infection requiring systemic therapy at enrollment
- Evidence of interstitial lung disease or active non-infectious pneumonitis
- History of solid organ transplantation
- Myocardial infarction or symptomatic congestive heart failure (NYHA class > II) within 6 months before study treatment
- Known history of HIV, active Hepatitis B or C, or active tuberculosis
- Any condition, therapy, or lab abnormality that may interfere with study participation or results
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Serious nonhealing wound, ulcer, or bone fracture within 28 days before first study dose
- Female subjects of childbearing potential unwilling to use contraception during treatment and 60 days after
- Female subjects breastfeeding or planning to breastfeed during study and 60 days after last dose
- Female subjects planning pregnancy or egg donation during study and 60 days after last dose
- Positive pregnancy test at screening for females of childbearing potential
- Male subjects with female partners of childbearing potential unwilling to use contraception or abstain during treatment and 60 days after last dose
- Male subjects with pregnant partners unwilling to abstain or use condoms during treatment and 60 days after last dose
- Known sensitivity to any study treatment components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Hospital General Universitario de Albacete
Albacete, Albacete, Spain, 02006
Not Yet Recruiting
2
Hospital General Universitario Dr. Balmis de Alicante
Alicante, Alicante, Spain, 03010
Not Yet Recruiting
3
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
Not Yet Recruiting
4
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain, 08025
Not Yet Recruiting
5
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona, Spain, 08035
Not Yet Recruiting
6
Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain, 08036
Not Yet Recruiting
7
Fundació Althaia
Manresa, Barcelona, Spain, 08243
Not Yet Recruiting
8
Hospital de Basurto
Bilbao, Bizkaia, Spain, 48013
Not Yet Recruiting
9
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain, 11407
Not Yet Recruiting
10
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain, 27003
Not Yet Recruiting
11
Hospital Clínico San Carlos
Madrid, Madrid, Spain, 28040
Not Yet Recruiting
12
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain, 28040
Not Yet Recruiting
13
Hospital Universitario Puerta de Hierro
Madrid, Madrid, Spain, 28222
Not Yet Recruiting
14
Hospital Son Espases
Palma de Mallorca, Mallorca, Spain, 07120
Not Yet Recruiting
15
Hospital Son Llàtzer
Palma de Mallorca, Mallorca, Spain, 07198
Not Yet Recruiting
16
Hospital Regional de Málaga
Málaga, Málaga, Spain, 29010
Actively Recruiting
17
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain, 31008
Not Yet Recruiting
18
Hospital Santa Maria Mai - Complexo Hospitalario Universitario Ourense
Ourense, Ourense, Spain, 32005
Not Yet Recruiting
19
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Tenerife, Spain, 38010
Not Yet Recruiting
20
Hospital General Universitario de Valencia
Valencia, Valencia, Spain, 46014
Not Yet Recruiting
Research Team
E
Eva Pereira
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here