Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
ConditionSmall Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAmgen
About this trial
The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and/or recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab.
Eligibility criteria
Qualifiers
Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
For Part 1, participants must have SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.
For Parts 1 and 2, participants must have progressed or recurred following at least 1 line of platinum-based therapy. No prior tarlatamab is allowed in Cohort 2-1.
For Part 3, participants must have extensive-stage SCLC (ES-SCLC) with no prior systemic treatment other than 1 cycle of platinum-based chemotherapy.
Disqualifiers
Symptomatic CNS metastases. Participants with treated brain metastases are eligible provided they meet the criteria specified in the protocol.
History of interstitial lung disease (ILD)/pneumonitis.
Received thoracic radiation therapy within 90 days prior to first dose of trial intervention.
Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy.
Trial design
Treatments tested in this trial
- ZL-1310
- Tarlatamab
- Durvalumab
Treatment groups
160 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov