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Tarlatamab for the Treatment of Extensive Stage Small-cell Lung Cancer

ConditionExtensive Stage Lung Small Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAsrar Alahmadi

About this trial

This phase II trial tests the effect of tarlatamab in treating patients with small-cell lung cancer (SCLC) that has spread from where it first started to other parts of the body (extensive-stage). SCLC is an aggressive cancer that has a low 5-year survival rate. Tarlatamab is a bispecific antibody that can bind to two different antigens at the same time. Tarlatamab binds to DLL3, a protein found on the surface of some types of tumor cells, including small-cell lung cancer, and to CD3, which is present on immune system T-cells (a type of white blood cell), and may interfere with tumor cell ability to grow and spread. This may increase the time to progression (growing, spreading, or worsening) and help patients with extensive-stage SCLC live longer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information

NOTE: HIPAA authorization may be included in the informed consent or obtained separately

Age ≥ 18 years at the time of consent

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2

Disqualifiers

Patients currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of treatment

Patients with a prior or concurrent malignancy whose natural history or treatment could potentially interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial

Symptomatic brain metastases and/or leptomeningeal disease

Clinically significant cardiovascular disease per the investigator. Examples include unstable arrhythmia, unstable angina, myocardial infarction, and/or symptomatic congestive heart failure (New York Heart Association class II) within 3 months of the first dose of tarlatamab

Trial design

Design model

Single group

Treatments tested in this trial

  • Biopsy Procedure

    Procedure/Surgery

    Undergo biopsies

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo computed tomography

  • Echocardiography Test

    Procedure/Surgery

    Undergo ECHO

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Multigated Acquisition Scan

    Procedure/Surgery

    Undergo MUGA

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Tarlatamab

    Drug

    Given IV

Treatment groups

39 Participants
are divided into 1 treatment group
Group A: Treatment (tarlatamab)Experimental treatment 9 interventions

Trial outcomes

Primary outcomes

1

6-month progression-free survival (PFS)

Will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or death as a result of any cause. Will be calculated as the proportion of patients who are progression-free and alive divided by the total number of evaluable patients. Exact binomial 95% confidence intervals (CIs) for the 6-month PFS true rate will be calculated.

Time frame
From the initiation of investigational therapy to progression, symptomatic deterioration, or death due to any cause, whichever comes first, assessed up to 6 months
2

Rapid progressive disease (PD) on tarlatamab rate probability (Interim analysis for futility monitoring)

Will be measured by RECIST v 1.1. Will be measured by the proportion of patients who have clinical and rapid clinical and radiological progression and move on to receive subsequent standard of care platinum-based chemotherapy and immune checkpoint inhibitors divided by the total number of evaluable patients. Exact binomial 95% CIs for the tarlatamab failure true rate will be calculated.

Time frame
Within 4 weeks of starting tarlatamab

Secondary outcomes

1

Rate of all adverse events (AEs)

Will be summarized using National Cancer Institute Common Terminology Criteria for Adverse Events v 5.0. Frequency and severity and tolerability of the regimen will be collected and summarized using descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of all and severe (grade 3+) AEs or toxicities will be described. Time to onset and duration will be described. The number of patients who required dose delays and/or treatment discontinuation will be assessed. Will capture the proportion of patients who go off treatment due to adverse reactions or even those who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial.

Time frame
Up to 30 days after last dose of study treatment
2

Rate of all cytokine release syndrome

Will be measured using American Society for Transplantation and Cellular Therapy (ASTCT). Frequency and severity and tolerability of the regimen will be collected and summarized using descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of all and severe (grade 3+) AEs or toxicities will be described. Time to onset and duration will be described. The number of patients who required dose delays and/or treatment discontinuation will be assessed. Will capture the proportion of patients who go off treatment due to adverse reactions or even those who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial.

Time frame
Up to 30 days after last dose of study treatment
3

Rate of all immune effector cell associated neurotoxicity syndrome

Will be measured using ASTCT. Frequency and severity and tolerability of the regimen will be collected and summarized using descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of all and severe (grade 3+) AEs or toxicities will be described. Time to onset and duration will be described. The number of patients who required dose delays and/or treatment discontinuation will be assessed. Will capture the proportion of patients who go off treatment due to adverse reactions or even those who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial.

Time frame
Up to 30 days after last dose of study treatment
4

Overall objective response rate (ORR)

Will be calculated by the proportion of patients with confirmed complete response (CR) or partial response (PR) using RECIST v 1.1 divided by the total number of evaluable patients. Exact binomial 95% CIs for the true PR + CR response rate will be calculated.

Time frame
Up to 2 years after last dose of study treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asrar Alahmadi

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Amgen

Collaborator

Source ClinicalTrials.gov
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