A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorETOP IBCSG Partners Foundation
About this trial
START-lung is an international, multicentre, single-arm phase II trial. Protocol treatment consists of tarlatamab administered as an intravenous infusion until disease progression according to RECIST v1.1 criteria, unacceptable toxicity, or patient decision, whichever comes first. The primary objective of the trial is to assess the clinical efficacy of tarlatamab, in terms of 12-month OS rate, in patients with ES-SCLC and ECOG PS 2 who have previously received only one line of platinum-etoposide doublet chemotherapy with immune-checkpoint inhibition and whose disease has progressed.
Eligibility criteria
Qualifiers
Histologically or cytologically confirmed ES-SCLC.
Previous treatment with only one line of platinum-etoposide doublet chemotherapy with immune-checkpoint inhibition for SCLC.
Progressive disease on or after the first-line treatment for SCLC.
ECOG Performance Status 2.
Disqualifiers
Symptomatic CNS metastases Patients with untreated asymptomatic brain metastases and patients with treated and stable brain metastases are eligible.
Diagnosis or evidence of leptomeningeal disease or spinal cord compression
any severe or life-threatening immune-mediated adverse event,
history of immune-mediated encephalitis or another immune-mediated CNS event (any grade),
Trial design
Treatments tested in this trial
- Tarlatamab
Treatment groups
48 Participants
are divided into 1 treatment groupSponsors and collaborators
ETOP IBCSG Partners Foundation
Lead sponsor
Amgen
Collaborator
Source ClinicalTrials.gov