Small Cell Lung CancerPhase 2T-BRAINNCT07402343
Tarlatamab for SCLC Brain Metastases
A Phase 2 study testing Tarlatamab in people with Small Cell Lung Cancer and Brain Metastases, Adult, run by Maastricht University Medical Center at 4 sites in Netherlands.
Trial summary
A single arm phase II study evaluating intracranial efficacy of tarlatamab in patients with asymptomatic active brain metastases from small cell lung cancer (SCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer, Brain Metastases, Adult
- What is being tested?
- Tarlatamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesNetherlands
- Study dates
- 10 Aug 2026to Feb 2030
- Phase
- Phase 2
- 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
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Signed and written informed consent
- Age 18 years or older
- Patients with pathology proven metastatic SCLC
- Pretreated with at least platinum-doublet chemotherapy with or without immunotherapy, no maximum of previous lines of systemic therapy
- WHO/ECOG PS 0-1
Show all 16Show fewer
- Estimated life expectancy 12 weeks or more
- At least one asymptomatic active (newly diagnosed or unequivocally progressive) untreated brain metastasis ≥ 5mm:
- Subjects with largest measurable intracranial lesion ≥5 mm but <10mm may be allowed to enroll upon agreement with investigator (for patients with target lesions of ≥ 5mm but <10 mm, 1.5 mm slice thickness brain MRI is required).
- "Untreated" refers to the lesion not being previously treated with stereotactic radiosurgery/therapy (SRS/SRT) or surgery.
- Prior treatment with whole brain radiation therapy or local surgery is permissible provided unequivocal progression in the lesion has since occurred
- For at least 7 days prior to study start: Patient must be asymptomatic from CNS metastases and on a stable dose of anti-epileptics and corticosteroids. Maximum dose of steroids is 10 mg prednisolone or equivalent/day, dose should be noted.
- Adequate organ and bone marrow function, defined as:
- Hematological function: i. Absolute neutrophil count ≥1.5 x109/L ii. Platelet count ≥ 100 x109/L iii. Hemoglobin ≥ 5.6 mmol/l b. Coagulation function: i. Protrombin time (PT)/ international normalized ratio (INR) and partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 x institutional upper limit of normal (ULN) except for subjects receiving anticoagulation, who must be on a stable dose of anticoagulant therapy for 6 weeks prior to start of study treatment.
- Renal function: i. Estimated glomerular filtration rate (eGFR) based on Modification of Dietin Renal Disease (MDRD) calculation > 30 mL/min/1.73 m2 d. Hepatic function: i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3x ULN (or < 5x ULN for subjects with liver metastases) ii. Total bilirubin < 1.5x ULN (or < 2x ULN for subjects with liver metastases), except for subjects with Gilberts disease e. Pulmonary function: i. No clinically significant pleural effusion. Pleural effusions managed with indwelling pleural catheter (eg, PleurX) are allowed.
- Baseline oxygen saturation > 90% on room air f. Cardiac function: i. Cardiac ejection fraction ≥50%, no clinically significant pericardial effusion as determined by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no clinically significant electrocardiogram (ECG) finding
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Symptomatic BM (if asymptomatic with corticosteroids with a maximum dose of steroids of 10 mg prednisolone or equivalent/day, the patient is eligible). If in doubt, discussion with the sponsor is necessary
- Leptomeningeal metastases (evaluated with MRI brain)
- BM in eloquent area (to be discussed with neuro-oncologist)
- Contra-indication for MRI
- Prior history of severe or life-threatening events from any immune-mediated therapy
Show all 47Show fewer
- Grade 2 or higher toxicity from previous systemic therapy, except for alopecia
- History of other malignancy within the past 2 years, with the following exceptions:
- Malignancy treated with curative intent before enrolment, with no known active disease and felt to be at low risk for recurrence by the treating physician, after discussion with the sponsor
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- adequately treated cervical cancer in situ without evidence of disease
- adequately treated breast ductal carcinoma in situ without evidence of disease
- prostatic intraepithelial neoplasia without evidence of prostate cancer
- adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g. colitis or Crohn's disease], systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc), autoimmune pneumonitis, and autoimmune myocarditis. The following are exceptions to this criterion:
- Subjects with vitiligo or alopecia
- Subjects with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Subjects without active disease in the last 5 years may be included but only after consultation with the sponsor
- Subjects with coeliac disease controlled by diet alone
- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II, appendix 2), within 6 months prior to first dose of study treatment
- History of arterial thrombosis (e.g. stroke or transient ischemic attack) within 6 months prior to first dose of study treatment
- Evidence of ILD or active, non-infectious pneumonitis
- History of solid organ transplant
- Major surgical procedures within 28 days prior to first dose of study treatment
- Presence of active HIV or hepatitis infection
- HIV infection: subjects with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of the treatment on study per local or institutional guidelines
- Active hepatitis C infection (subjects with detectable hepatitis C antibody [HCV Ab] and hepatitis C virus (HCV) RNA viral load above the limit of quantification) are not allowed. Subjects with presence of HCV antibody (HCV Ab positive) and HCV RNA viral load below the limit of quantification (HCV RNA negative) with or without prior treatment are allowed
- Active hepatitis B infection (subjects with presence of hepatitis B surface antigen [HBsAg-positive] and hepatitis B virus (HBV) DNA viral load above the limit of quantification [HBV DNA positive) are not allowed. Subjects with resolved HBV infection, defined as absence of HBV surface antigen (HBsAg-negative) and presence of HBV core antibody (anti-HBc positive) followed by an HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines. Subjects with inactive HBV infection inactive carrier state, defined as presence of HBV surface antigen (HBsAg-positive) and HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed with the requirement for regular monitoring for reactivation for the duration of the treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.
- Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment
- Low-dose corticosteroids (prednisone ≤ 10 mg per day or equivalent is permitted during the study)
- Subjects with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment
- Note: simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment. Subjects requiring oral antibiotics who have been afebrile > 24 hours, have no leukocytosis, nor clinical signs of an infection are eligible. Screening for chronic infectious conditions is not required unless otherwise noted as exclusion criteria.
- Treatment with live virus, including live-attenuated vaccination, within 4 weeks prior to the first dose of study treatment. Inactive vaccines (e.g. non-live or non-replication agent) and live viral non-replicating vaccines (e.g. Jynneos for mpox infection) within 3 days prior to first dose of study treatment
- Prior therapy with any selective inhibitor of the DLL3 pathway
- Receiving another anticancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted.
- Treatment in an alternative investigational trial within 28 days prior to enrollment
- Female subjects of childbearing potential unwilling to use protocol specified method of contraception (appendix 3) during treatment and for an additional 60 days after the last dose of tarlatamab
- Female subjects who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of tarlatamab
- Female subjects planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab
- Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test
- Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose of tarlatamab
- Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of tarlatamab
- Male subjects unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of tarlatamab
- Subject has known sensitivity to any of the products or components to be administered during dosing of tarlatamab.
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- Subjects likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigators knowledge.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands4 sites, 4 recruiting
- Recruiting
The Netherlands Cancer Institute
Amsterdam
W. Theelen, MD, PhD
- Recruiting
University Medical Center Groningen
Groningen
F. Bensch, MD, PhD
- Recruiting
Maastricht UMC+
Maastricht
L. Hendriks, MD, PhD, +31(0)43-3875047, lizza.hendriks@mumc.nl
L. Hendriks, MD, PhD
- Not yet recruiting
Erasmus MC
Rotterdam
prof. A. Dingemans, MD, PhD
About this study
Official title: A Single Arm Phase II Study Evaluating Intracranial Efficacy of Tarlatamab in Patients With Asymptomatic Active Brain Metastases From Small Cell Lung Cancer
A single arm phase II study evaluating intracranial efficacy of tarlatamab in patients with asymptomatic active brain metastases from small cell lung cancer (SCLC).
Read the detailed description
Patients with small cell lung cancer (SCLC) have a high risk of brain metastases (BM). Due to the decline in the use of prophylactic cranial irradiation (PCI), because of the risk of toxicity in absence of a survival benefit, as well as increased imaging follow-up, the incidence of BM in SCLC will rise compared to the PCI-era. Upon central nervous system (CNS) progression on first line therapy, cranial radiotherapy can be given but effect is modest. All standard of care second line drugs have limited (prolonged) efficacy in the CNS, or efficacy is unknown. Therefore, new systemic therapies that are active systemically as well as intracranially are needed.
Tarlatamab is a bispecific T-cell engager targeting delta-like ligand 3 (DLL3) and CD3 and has shown promising activity in heavily pretreated patients with SCLC. With a median follow-up of 20.7 months, objective response rate (ORR) was 40% in a phase II trial, DCR was 70%, median PFS was 4.3 months, median OS 15.2 months and 26% had sustained disease control ≥52 weeks. The most common adverse event was cytokine release syndrome (CRS, 53% in the 10 mg group), with the majority being grade 1-2, and 1% grade 3. Similar long-term follow-up data was reported for the phase I trial. CNS disease progression occurred in only 9/112 enrolled patients (25% had baseline BM).
Seventeen patients with previously treated BM with a size of ≥ 10mm were enrolled. Modified Response Assessment in Neuro-Oncology (RANO) criteria showed CNS tumor shrinkage ≥30% in 59% (10/17) of these patients, and intracranial disease control in 94%. Out of the 10 patients with CNS tumor shrinkage of ≥30%, five had cranial radiotherapy >5 weeks before the start of tarlatamab, which indirectly indicates that tarlatamab could have intracranial activity. Additionally, the confirmatory randomized phase III trial DeLLphi-304 (NCT05740566) enrolling patients with relapsed SCLC and randomizing between tarlatamab and standard of care chemotherapy was positive for its primary outcome, OS. Median OS was 13.6 months for tarlatamab and 8.3 months for standard of care (hazard ratio 0.60, 95% confidence interval 0.47-0.77, p <0.001). Additionally, tarlatamab resulted in a PFS benefit as well as less treatment related toxicity. Moreover, patients with (treated) BM derived at least the same magnitude of benefit (HR for OS with baseline BM 0.45, HR for OS if no baseline BM 0.81). At the end of the enrollment, the protocol was amended to allow patients with asymptomatic untreated BM. However, meaningful data regarding CNS efficacy of tarlatamab will not be obtained in this study. Therefore, it is of interest to evaluate tarlatamab in patients with SCLC with disease progression including BM on first line systemic therapy.
- Conditions
- Small Cell Lung Cancer, Brain Metastases, Adult
- Being tested
- Tarlatamab
- Medical subject headings
- Small Cell Lung Carcinoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TarlatamabDrug
Cycle 1: 1 mg on day 1, followed by 10 mg on days 8 and 15 Cycles thereafter: 10 mg every two weeks, in cycles of 28 days Treatment continues till unacceptable toxicity or disease progression
| Study group | Role | What they receive |
|---|---|---|
| Tarlatamab | Experimental | Tarlatamab intravenous: 1 mg on day 1, followed by 10 mg on days 8 and 15 of cycle 1; thereafter every 2 weeks in cycles of 28 days Receives: Drug: Tarlatamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial overall response rate (ORR)
Brain metastases ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) based on central and local investigator's assessment according to RANO-BM criteria on brain MRI
Measured: Up to 36 months
Secondary outcomes (8)
Brain metastases (BM) disease control rate (DCR)
DCR is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Non-CR/Non-PD according to RANO-BM on brain MRI
Measured: Up to 36 months
Median CNS PFS
According to RANO-BM on brain MRI
Measured: Up to 36 months
Extracranial ORR
Extracranial ORR is evaluated according to RECIST 1.1, measured with CT. ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment
Measured: Up to 36 months
Extracranial DCR
Extracranial DCR is evaluated according to RECIST 1.1, measured with CT. DCR is defined as the proportion of participants with Best Overall Response (BOR) of CR, PR, Stable Disease (SD) or Non-CR/Non-PD.
Measured: Up to 36 months
Extracranial PFS
Extracranial progression free survival (PFS) will be assessed according to RECIST 1.1 based on CT.
PFS is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause.
Measured: Up to 36 months
Overall PFS
Overall progression free survival (PFS) is evaluated according to RECIST 1.1 based on CT for extracranial lesions, and RANO-BM based on MRI for BM.
Measured: Up to 36 months
Overall survival
Overall survival (OS) is defined as the time from date of start of treatment to date of death due to any cause
Measured: Up to 48 months
Number of patients experiencing adverse events according to CTCAE and ASTCT criteria
Number of patients experiencing adverse events, according to ASTCT 2019 criteria for immuno effector cell-associated neurotoxicity syndrome (ICANS) and cytokine release syndrome (CRS), and according to CTCAE v5.0 for other adverse events.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start10 Aug 2026
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Netherlands Cancer Institute, Erasmus Medical Center, University Medical Center Groningen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402343
- Sponsor's protocol ID
- T-BRAIN
- Other IDs
- 2025-522162-75-00, 2025
- Acronym
- T-BRAIN
- Status last verified
- Oct 2026
- First submitted
- 15 Jan 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase II Study Evaluating Intracranial Efficacy of Tarlatamab in Patients With Asymptomatic Active Brain Metastases From Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07402343
- Acronym / sponsor ID
- T-BRAIN / T-BRAIN
- Conditions
- Small Cell Lung Cancer, Brain Metastases, Adult
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- The Netherlands Cancer Institute, Erasmus Medical Center, University Medical Center Groningen
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single arm phase II study evaluating intracranial efficacy of tarlatamab in patients with asymptomatic active brain metastases from small cell lung cancer (SCLC).
Detailed description
Patients with small cell lung cancer (SCLC) have a high risk of brain metastases (BM). Due to the decline in the use of prophylactic cranial irradiation (PCI), because of the risk of toxicity in absence of a survival benefit, as well as increased imaging follow-up, the incidence of BM in SCLC will rise compared to the PCI-era. Upon central nervous system (CNS) progression on first line therapy, cranial radiotherapy can be given but effect is modest. All standard of care second line drugs have limited (prolonged) efficacy in the CNS, or efficacy is unknown. Therefore, new systemic therapies that are active systemically as well as intracranially are needed.
Tarlatamab is a bispecific T-cell engager targeting delta-like ligand 3 (DLL3) and CD3 and has shown promising activity in heavily pretreated patients with SCLC. With a median follow-up of 20.7 months, objective response rate (ORR) was 40% in a phase II trial, DCR was 70%, median PFS was 4.3 months, median OS 15.2 months and 26% had sustained disease control ≥52 weeks. The most common adverse event was cytokine release syndrome (CRS, 53% in the 10 mg group), with the majority being grade 1-2, and 1% grade 3. Similar long-term follow-up data was reported for the phase I trial. CNS disease progression occurred in only 9/112 enrolled patients (25% had baseline BM).
Seventeen patients with previously treated BM with a size of ≥ 10mm were enrolled. Modified Response Assessment in Neuro-Oncology (RANO) criteria showed CNS tumor shrinkage ≥30% in 59% (10/17) of these patients, and intracranial disease control in 94%. Out of the 10 patients with CNS tumor shrinkage of ≥30%, five had cranial radiotherapy >5 weeks before the start of tarlatamab, which indirectly indicates that tarlatamab could have intracranial activity. Additionally, the confirmatory randomized phase III trial DeLLphi-304 (NCT05740566) enrolling patients with relapsed SCLC and randomizing between tarlatamab and standard of care chemotherapy was positive for its primary outcome, OS. Median OS was 13.6 months for tarlatamab and 8.3 months for standard of care (hazard ratio 0.60, 95% confidence interval 0.47-0.77, p <0.001). Additionally, tarlatamab resulted in a PFS benefit as well as less treatment related toxicity. Moreover, patients with (treated) BM derived at least the same magnitude of benefit (HR for OS with baseline BM 0.45, HR for OS if no baseline BM 0.81). At the end of the enrollment, the protocol was amended to allow patients with asymptomatic untreated BM. However, meaningful data regarding CNS efficacy of tarlatamab will not be obtained in this study. Therefore, it is of interest to evaluate tarlatamab in patients with SCLC with disease progression including BM on first line systemic therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tarlatamab | Experimental | Drug: TarlatamabTarlatamab intravenous: 1 mg on day 1, followed by 10 mg on days 8 and 15 of cycle 1; thereafter every 2 weeks in cycles of 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Signed and written informed consent
- Age 18 years or older
- Patients with pathology proven metastatic SCLC
- Pretreated with at least platinum-doublet chemotherapy with or without immunotherapy, no maximum of previous lines of systemic therapy
Key exclusion criteria (47 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Symptomatic BM (if asymptomatic with corticosteroids with a maximum dose of steroids of 10 mg prednisolone or equivalent/day, the patient is eligible). If in doubt, discussion with the sponsor is necessary
- Leptomeningeal metastases (evaluated with MRI brain)
- BM in eloquent area (to be discussed with neuro-oncologist)
- Contra-indication for MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TarlatamabCycle 1: 1 mg on day 1, followed by 10 mg on days 8 and 15 Cycles thereafter: 10 mg every two weeks, in cycles of 28 days Treatment continues till unacceptable toxicity or disease progression | Drug | Tarlatamab |
Primary outcome
Intracranial overall response rate (ORR)
Time frame: Up to 36 months
Brain metastases ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) based on central and local investigator's assessment according to RANO-BM criteria on brain MRI
8 secondary outcomes
Brain metastases (BM) disease control rate (DCR)
Time frame: Up to 36 months
Median CNS PFS
Time frame: Up to 36 months
Extracranial ORR
Time frame: Up to 36 months
Extracranial DCR
Time frame: Up to 36 months
Extracranial PFS
Time frame: Up to 36 months
Overall PFS
Time frame: Up to 36 months
Overall survival
Time frame: Up to 48 months
Number of patients experiencing adverse events according to CTCAE and ASTCT criteria
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tarlatamab in people with Small Cell Lung Cancer and Brain Metastases, Adult, run by Maastricht University Medical Center at 4 sites in Netherlands.
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 16 inclusion and 47 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Lizza Hendriks, MD, PhD (+31(0)43-3875047, lizza.hendriks@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial overall response rate (ORR) (time frame: Up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.