Recruiting
Phase 1

Tarlatamab & ZL-1310

Sponsor:

Amgen

Code:

NCT07531095

Conditions

Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ZL-1310

Tarlatamab

Durvalumab

Study Details

Brief summary:

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.

Conditions

Small Cell Lung Cancer

Study ID

NCT07531095

Start date

Apr 21, 2026

Status verified date

Aug, 2026

Completion date

May 21, 2031

Anticipated

Primary completion date

May 21, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Exploration (Part 1)

Multiple dose levels of ZL-1310 will be explored in combination with tarlatamab administered intravenously (IV).

experimental: Dose Expansion (Part 2)

ZL-1310 will be administered IV at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV.

experimental: Triplet Combination (Part 3)

ZL-1310 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (durvalumab) each administered IV.

Interventions

ZL-1310

ZL-1310 will be administered as an IV infusion.

Tarlatamab

Tarlatamab will be administered as an IV infusion.

Durvalumab

Durvalumab will be administered as an IV infusion.

Primary outcome measure

  • Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 3.5 years ]
  • Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) [ Time Frame: Up to Day 21 ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

City of Hope Cancer Center Phoenix

Recruiting

Goodyear, Arizona, United States, 85338

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

City of Hope Chicago

Recruiting

Zion, Illinois, United States, 60099

Health Partners Cancer Center at Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

New York University Cancer Institute

Recruiting

New York, New York, United States, 10016

Baptist Cancer Center

Recruiting

Memphis, Tennessee, United States, 38120

Next Virginia

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Amgen

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • Tarlatamab
  • ZL-1310
  • Durvalumab
  • SCLC
  • Anti-PD-L1
  • Extensive Stage Small Cell Lung Cancer
  • Programmed death protein-1 (PD-1)
  • Programmed death ligand 1 (PD-L1)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amgen on 2026-08-21.