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Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)

NCT07531095

RecruitingPhase 1

Sponsor: Amgen

Conditions: Small Cell Lung Cancer

Interventions: ZL-1310, Tarlatamab, Durvalumab

Countries: United States, Australia, Belgium, France, Germany, Poland, Spain, Switzerland

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 overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
* Participants with Histologically or cytologically confirmed SCLC:
* 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.

Note: Participants with prior treatment for limited-stage SCLC (LS-SCLC) before diagnosis of ES SCLC are permitted.

* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* At least 1 measurable lesion as defined per RECIST v1.1 within 21-day screening period, not previously irradiated.
* Adequate organ function (hematological, coagulation, renal, hepatic, pulmonary, and cardiac function).

Exclusion Criteria:

* 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.
* Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.
* Receiving strong CYP3A4 or CPY2D6 inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose of trial treatment.
* Enrollment in any tarlatamab clinical trial.
Locations (27)
  • Goodyear, Arizona, United States
  • Tampa, Florida, United States
  • Zion, Illinois, United States
  • Saint Paul, Minnesota, United States
  • New York, New York, United States
  • Memphis, Tennessee, United States
  • Fairfax, Virginia, United States
  • Clayton, Victoria, Australia
  • Brussels, Belgium
  • Ghent, Belgium
  • Wilrijk, Belgium
  • Bron, France
  • Marseille, France
  • Villejuif, France
  • Dresden, Germany
  • Würzburg, Germany
  • Gdansk, Poland
  • Gliwice, Poland
  • Málaga, Andalusia, Spain
  • Barcelona, Catalonia, Spain
  • Valencia, Valencia, Spain
  • Madrid, Spain
  • Madrid, Spain
  • Sankt Gallen, Switzerland
  • Adana, Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
  • Izmir, Turkey (Türkiye)