What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, immunotherapy, and targeted therapies like Tarlatamab. Chemotherapy regimens, such as etoposide combined with either cisplatin or carboplatin, often cause side effects like nausea, vomiting, hair loss, fatigue, and increased risk of infections due to bone marrow suppression. Immunotherapy, including anti-PD-1 or anti-PD-L1 therapies, can lead to immune-related adverse effects such as colitis, pneumonitis, hepatitis, and endocrinopathies. Targeted therapies like Tarlatamab, which aim to enhance anti-tumor activity by targeting specific cancer cells, may also cause similar immune-related side effects, along with potential infusion-related reactions.

What prior FDA approvals exist?

FDA-approved treatments for Small Cell Lung Cancer (SCLC) that target specific cancer cells include immune checkpoint inhibitors such as nivolumab and pembrolizumab. These drugs work by targeting the PD-1/PD-L1 pathway, enhancing the immune system's ability to attack cancer cells. Additionally, atezolizumab, another immune checkpoint inhibitor, has been approved for use in combination with chemotherapy (etoposide and carboplatin/cisplatin) for extensive-stage SCLC. These treatments are similar to Tarlatamab, which is being studied for its anti-tumor activity by targeting specific cancer cells.

What other types of research exist?

Promising novel alternatives to Tarlatamab for SCLC patients include Larotrectinib, a highly selective TRK inhibitor effective in TRK fusion-positive cancers, and investigational approaches combining EGFR antibody targeting with T cell-mediated cytotoxicity. Additionally, novel EML4-ALK inhibitors and MEK inhibitors are in clinical development and may offer targeted therapeutic options.

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Monoclonal Antibodies

Tarlatamab for Small Cell Lung Cancer (DeLLphi-301 Trial)

Phase 2

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 relapsed/refractory SCLC

Participants who progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy.

Must not have

Female participants of childbearing potential with a positive pregnancy test assessed at screening and/or day 1 by a highly sensitive urine or serum pregnancy test.

Untreated or symptomatic brain metastases and leptomeningeal disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing tarlatamab, a new medication aimed at treating solid tumors. It focuses on patients whose tumors may not respond well to other treatments. Tarlatamab works by helping the immune system recognize and destroy cancer cells.

Who is the study for?

This trial is for adults over 18 with relapsed/refractory Small Cell Lung Cancer (SCLC) who have tried at least one platinum-based therapy and another treatment. They must have a life expectancy of at least 12 weeks, measurable cancer lesions, and be in fairly good health (ECOG status of 0 or 1). Participants with treated brain metastases may join if they meet certain criteria. Pregnant women, those planning to become pregnant, or breastfeeding are excluded, as well as anyone unwilling to use contraception.

What is being tested?

The study tests two dose levels of Tarlatamab for safety and effectiveness against SCLC tumors. It's divided into parts: the first evaluates safety/effectiveness per RECIST 1.1 standards; the second assesses tumor response rate by independent review; the third looks at safety regarding reduced monitoring after initial doses.

What are the potential side effects?

While specific side effects aren't listed here, common ones from treatments like Tarlatamab can include immune-related reactions such as inflammation in organs, fatigue, infusion reactions similar to allergic responses during drug administration, digestive issues like nausea or diarrhea, blood disorders affecting cell counts leading to increased infection risk.

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 come back or didn't respond to treatment.

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My cancer returned or worsened after 1 platinum-based treatment and another therapy.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I am not pregnant, as confirmed by a sensitive test.

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I have brain metastases or leptomeningeal disease that hasn't been treated or is causing symptoms.

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I have a lung condition not caused by an infection.

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I had severe reactions to previous immune therapy.

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

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I have not taken steroids or immunosuppressants in the last 7 days.

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

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I have had issues with my pituitary gland.

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I am not breastfeeding nor plan to while on the study and for 72 days after the last dose.

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I have previously been treated with tarlatamab.

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I agree not to donate sperm during and for 132 days after my last dose of tarlatamab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 3: Modified Monitoring SubstudyExperimental Treatment1 Intervention

Participants will receive the selected target dose of Tarlatamab based on findings in Part 1 with reduced Cycle 1 monitoring requirements.

Group II: Part 2: Dose ExpansionExperimental Treatment1 Intervention

Participants will receive the selected target dose of Tarlatamab based on findings in Part 1.

Group III: Part 1: Tarlatamab Low DoseExperimental Treatment1 Intervention

Participants will receive the low dose of Tarlatamab.

Group IV: Part 1: Tarlatamab High DoseExperimental Treatment1 Intervention

Participants will receive the high dose of Tarlatamab.

0 / 14Eligibility 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

The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy drugs like etoposide and cisplatin work by damaging the DNA of cancer cells, causing them to die. Immunotherapy, such as anti-PD-1 or anti-PD-L1 therapies, boosts the immune system's ability to detect and kill cancer cells. Targeted therapies, like tarlatamab, specifically bind to proteins or antigens on cancer cells, leading to their destruction. These mechanisms are vital for SCLC patients as they help in choosing the most effective treatment, potentially improving survival rates and reducing side effects.

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Who is running the clinical trial?

AmgenLead Sponsor

1,420 Previous Clinical Trials

1,382,728 Total Patients Enrolled

MDStudy DirectorAmgen

961 Previous Clinical Trials

928,643 Total Patients Enrolled

Media Library

Tarlatamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05060016 — Phase 2

Small Cell Lung Cancer Research Study Groups: Part 1: Tarlatamab Low Dose, Part 1: Tarlatamab High Dose, Part 2: Dose Expansion, Part 3: Modified Monitoring Substudy

Small Cell Lung Cancer Clinical Trial 2023: Tarlatamab Highlights & Side Effects. Trial Name: NCT05060016 — Phase 2

Tarlatamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05060016 — Phase 2

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