Tarlatamab for SCLC Brain Metastases

ConditionsSmall Cell Lung Cancer Brain Metastases, Adult

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorMaastricht University Medical Center

About this trial

A single arm phase II study evaluating intracranial efficacy of tarlatamab in patients with asymptomatic active brain metastases from small cell lung cancer (SCLC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Tarlatamab
Drug
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

Treatment groups

35 Participants

are divided into 1 treatment group

Group A: TarlatamabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Up to 36 months

Secondary outcomes

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

Time frame

Up to 36 months

Median CNS PFS

According to RANO-BM on brain MRI

Time frame

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

Time frame

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.

Time frame

Up to 36 months

Other outcomes

Efficacy of tarlatamab (survival) in relation to previous cranial radiotherapy

Exploratory endpoint: comparison of the efficacy of tarlatamab in patients who previously received cranial radiotherapy to the efficacy in those who were not previously treated with cranial radiotherapy

Time frame

Up to 36 months

Safety of tarlatamab (adverse events) in relation to previous cranial radiotherapy

Exploratory endpoint: comparison of the safety of tarlatamab in patients who previously received cranial radiotherapy to the safety of tarlatamab in those who were not previously treated with cranial radiotherapy

Time frame

Up to 36 months

Efficacy of tarlatamab in relation to concomitant steroid use

Exploratory endpoint: comparison of the efficacy of tarlatamab in patients who concomitantly used steroids to the efficacy in those who were not concomitant steroid users.

Time frame

Up to 36 months

Safety of tarlatamab (i.e. adverse events) in relation to concomitant steroid use

Exploratory endpoint: comparison of the safety of tarlatamab in patients who concomitantly used steroids to the safety in those who were not concomitant steroid users.

Time frame

Up to 36 months