Clinical trial · Interventional
Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| Tarlatamab | Drug | Tarlatamab | ALIAS |
| ZL-1310 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose Exploration (Part 1)
- description
- Multiple dose levels of ZL-1310 will be explored in combination with tarlatamab administered intravenously (IV).
- interventionNames
- Drug: ZL-1310
- Drug: Tarlatamab
- type
- EXPERIMENTAL
- label
- Dose Expansion (Part 2)
- description
- 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.
- interventionNames
- Drug: ZL-1310
- Drug: Tarlatamab
- type
- EXPERIMENTAL
- label
- Triplet Combination (Part 3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available