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NCT Number: NCT07531095

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

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.

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Adana Sehir Egitim ve Arastirma Hastanesi, Adana, Turkey (Türkiye)

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZL-1310

Drug

ZL-1310 will be administered as an IV infusion.

Tarlatamab

Drug

Tarlatamab will be administered as an IV infusion.

Other names: IMDELLTRA

Durvalumab

Drug

Durvalumab will be administered as an IV infusion.

Primary outcomes

  1. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to 3.5 years

  2. Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)

    Time frame: Up to Day 21

Secondary outcomes

  1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Time frame: Up to 3.5 years

  2. Duration of Response (DOR) per RECIST v1.1

    Time frame: Up to 3.5 years

  3. Time to Response (TTR) per RECIST v1.1

    Time frame: Up to 3.5 years

  4. Disease Control Rate (DCR) per RECIST v1.1

    Time frame: Up to 3.5 years

  5. Progression-free Survival (PFS) per RECIST v1.1

    Time frame: Up to 3.5 years

  6. Time to Progression (TTP) per RECIST v1.1

    Time frame: Up to 3.5 years

  7. Time to Subsequent Therapy

    Time frame: Up to 3.5 years

  8. Overall survival (OS)

    Time frame: Up to 3.5 years

  9. Serum Tarlatamab Concentrations

    Time frame: Up to Week 36

Study contacts

Contact information is provided by the study sponsor or research team.

Amgen Call Center

CONTACT

[email protected]

866-572-6436

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With ZL-1310 With or Without Anti-PD-L1 in Participants With Small Cell Lung Cancer

Acronym: DeLLphi-313

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Apr 15, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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