RightFit
RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests tarlatamab with ZL-1310, with or without durvalumab, in adults with small cell lung cancer. It checks how safe these drug combinations are and finds doses to use in future studies.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18, or the legal adult age in your country if it is higher.
  • Have small cell lung cancer confirmed by a tissue or cell test.
  • For Parts 1 and 2, cancer must have grown or returned after at least one course of platinum-based cancer treatment. Cohort 2-1 does not allow past tarlatamab use.
  • For Part 3, have widely spread small cell lung cancer and no past whole-body treatment except one cycle of platinum-based chemotherapy.
  • For Part 3, past treatment for small cell lung cancer that was still limited to a smaller area is allowed.
  • Be fully active or able to do light work, even if heavy activity is limited.
  • Have at least one tumor that can be measured during the 21-day screening period and has not been treated with radiation.
  • Have blood tests, blood clotting, kidneys, liver, lungs, and heart working well enough for the study.

Who can't join

  • Cancer spread to the brain or spinal cord that causes symptoms. Treated brain tumors may be allowed if study rules are met.
  • A history of lung inflammation or scarring called pneumonitis or interstitial lung disease.
  • Radiation treatment to the chest within 90 days before the first study dose.
  • Past treatment targeting DLL3, a protein on some cancer cells.
  • Past use of drugs called topoisomerase I inhibitors, including antibody-drug combinations that carry these drugs.
  • Use of medicines that strongly block the enzymes CYP3A4 or CYP2D6 too close to the first study dose: within 14 days, or longer for drugs that leave the body slowly.
  • Enrollment in any tarlatamab clinical trial.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (7)

AZ

FL

IL

MN

NY

TN

VA