What side effects are associated with this type of intervention?

The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy and immunotherapy. Chemotherapy regimens, such as etoposide with cisplatin or carboplatin, often cause side effects like nausea, vomiting, hair loss, fatigue, and increased infection risk. Immunotherapy, including immune checkpoint inhibitors like atezolizumab, can lead to fatigue, rash, diarrhea, and immune-related adverse events such as pneumonitis, colitis, and hepatitis. Treatments similar to Tarlatamab, a bispecific T-cell engager, may also cause cytokine release syndrome (CRS), neurotoxicity, and other immune-related side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Small Cell Lung Cancer (SCLC), including immunotherapies such as atezolizumab and durvalumab, which are immune checkpoint inhibitors targeting PD-L1. These treatments have shown efficacy in combination with chemotherapy for extensive-stage SCLC. While Tarlatamab, a bispecific T-cell engager targeting CD3 and DLL3, is still under investigation, it represents a novel approach in the treatment landscape of SCLC, aiming to harness the immune system to target cancer cells more effectively.

What other types of research exist?

Promising novel alternatives to Tarlatamab for SCLC patients include immune checkpoint inhibitors such as nivolumab and pembrolizumab, which have shown efficacy in various solid tumors including SCLC. Additionally, investigational therapies like bispecific antibodies targeting EGFR and NRP1, as well as other novel agents like CDK4 inhibitors (e.g., abemaciclib) and farnesyltransferase inhibitors (e.g., tipifarnib), are being explored for their potential benefits in treating SCLC.

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CAR T-cell Therapy

Tarlatamab for Small Cell Lung Cancer

Phase 1

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed SCLC. For parts A, C, D, E, F, and G: relapsed/refractory small cell lung cancer (R/R SCLC) who progressed or recurred following platinum-based regimen

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

Must not have

Has evidence of interstitial lung disease or active, non-infectious pneumonitis

Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of investigational product administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing tarlatamab, a special medicine, in people with Small Cell Lung Cancer. Tarlatamab helps the immune system find and destroy cancer cells.

Who is the study for?

Adults over 18 with small cell lung cancer that's come back or didn't respond after chemo can join. They must have stable brain metastases, good organ function, and an ECOG status of 0-2. No recent immunosuppressants, untreated brain issues, severe immune reactions to cancer drugs, active infections or major surgery within the last month.

What is being tested?

The trial is testing Tarlatamab's safety and how the body processes it in adults with SCLC. It includes strategies to manage side effects (CRS Mitigation) and compares Tarlatamab with Pembrolizumab—a known treatment.

What are the potential side effects?

Possible side effects include immune system reactions like inflammation in various organs, infusion-related symptoms such as fever or chills, fatigue, potential worsening of existing conditions like pneumonitis or autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My small cell lung cancer has returned or worsened after platinum-based treatment.

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I can take care of myself and am up and about more than half of my waking hours.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a lung condition not caused by an infection.

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I haven't had signs of a serious infection in the last week.

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I had severe side effects from immune therapy that stopped my treatment.

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I have not had major surgery within the last 4 weeks.

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I have untreated or worsening brain cancer spread, including in the protective layers of the brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Part GExperimental Treatment1 Intervention

Tarlatamab additional dosing schedule Optional wearable digital device substudy (US sites only)

Group II: Part FExperimental Treatment1 Intervention

Tarlatamab administered in outpatient infusion centers with 8-hour monitoring Optional wearable digital device substudy (US sites only)

Group III: Part EExperimental Treatment1 Intervention

Tarlatamab administration with 24-hour monitoring

Group IV: Part DExperimental Treatment2 Interventions

Tarlatamab with additional CRS mitigation strategies

Group V: Part CExperimental Treatment2 Interventions

Tarlatamab with Pembrolizumab

Group VI: Part AExperimental Treatment1 Intervention

Tarlatamab monotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tarlatamab

2021

Completed Phase 1

~70

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, immune checkpoint inhibitors, and bispecific T-cell engagers like Tarlatamab. Chemotherapy agents, such as etoposide and platinum compounds, work by damaging the DNA of cancer cells, leading to their death. Immune checkpoint inhibitors, like atezolizumab and durvalumab, enhance the immune system's ability to attack cancer cells by blocking proteins that inhibit immune responses. Bispecific T-cell engagers, such as Tarlatamab, target CD3 on T-cells and DLL3 on SCLC cells, bringing T-cells into close proximity with cancer cells to induce targeted cell death. These treatments are vital for SCLC patients due to the aggressive and metastatic nature of the disease, requiring effective and targeted therapeutic strategies.

Expression and pharmacological inhibition of thymidylate synthase and Src kinase in nonsmall cell lung cancer.