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Tarlatamab + AMG 404 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
Age greater than or equal to 18 years old at the same time of signing the informed consent
Participants with histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) who progressed or recurred following at least 1 platinum-based regimen
Must not have
History of solid organ transplantation
Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights


This trial is testing a new cancer drug combo to see if it's safe and works well.

Who is the study for?
Adults over 18 with Small Cell Lung Cancer (SCLC) that's worsened after platinum-based therapy can join. They must be fairly active (ECOG 0-1), have treated brain metastases meeting certain conditions, proper organ function, and no recent other cancers or major surgeries. Immune system issues, untreated brain problems, or prior similar treatments disqualify them.Check my eligibility
What is being tested?
The trial is testing the safety and best dose of tarlatamab combined with AMG 404 in treating SCLC. It aims to find out how well patients tolerate this combination and establish a recommended dosage for further studies.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting various organs, potential lung issues like pneumonitis, infusion-related reactions which could range from mild discomfort to severe responses requiring treatment discontinuation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am 18 years or older and can sign the consent form.
My small cell lung cancer returned after platinum-based treatment.
I can carry out all my daily activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
I have had an organ transplant.
I had severe side effects from immune therapy that stopped my treatment.
I have had issues with my pituitary gland.
I have not received tarlatamab or DLL3 x CD3 bispecific therapy before.
I have not taken steroids or immunosuppressants in the last 7 days.
I finished chemotherapy over 2 weeks ago and have no major side effects.
I have lung scarring or inflammation not caused by an infection.
I have not had major surgery within the last 4 weeks.
I have brain metastases or leptomeningeal disease that hasn't been treated or is causing symptoms.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests
Number of Participants with a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements
Number of Participants with a Clinically Significant Change from Baseline in Vital Signs
+3 more
Secondary outcome measures
Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Tarlatamab in Combination with AMG 404
Disease Control Rate (DCR)
Duration of Response (DOR)
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2: Dose ExpansionExperimental Treatment2 Interventions
Participants will receive the RP2D of tarlatamab in combination with AMG 404 identified in Phase 1 (dose exploration) of the study.
Group II: Phase 1: Dose ExplorationExperimental Treatment2 Interventions
The recommended phase 2 target dose (RP2D) of tarlatamab in combination with AMG 404 will be estimated using a modified toxicity probability interval (mTPI-2) design. A combination RP2D may be identified based on emerging safety, efficacy, and pharmacodynamic data prior to reaching an maximum tolerated dose (MTD).
First Studied
Drug Approval Stage
How many patients have taken this drug
AMG 404
Completed Phase 1

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
Tarlatamab, a bispecific T-cell engager, targets DLL3, a protein commonly expressed on SCLC cells, and redirects T-cells to attack these cancer cells. AMG 404, an anti-PD-1 monoclonal antibody, blocks the PD-1 pathway, enhancing the immune system's ability to detect and destroy cancer cells. These mechanisms are crucial for SCLC patients as they leverage the body's immune system to specifically target and eliminate cancer cells, potentially improving treatment efficacy and patient outcomes.
The efficacy of ado-trastuzumab emtansine in patients with ERBB2-aberrant non-small cell lung cancer: a systematic review.EGFR/Notch Antagonists Enhance the Response to Inhibitors of the PI3K-Akt Pathway by Decreasing Tumor-Initiating Cell Frequency.Targeted therapy for thymic epithelial tumors: a new horizon? Review of the literature and two cases reports.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,392 Previous Clinical Trials
1,381,097 Total Patients Enrolled
MDStudy DirectorAmgen
937 Previous Clinical Trials
927,244 Total Patients Enrolled

Media Library

AMG 404 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04885998 — Phase 1
Small Cell Lung Cancer Research Study Groups: Phase 1: Dose Exploration, Phase 2: Dose Expansion
Small Cell Lung Cancer Clinical Trial 2023: AMG 404 Highlights & Side Effects. Trial Name: NCT04885998 — Phase 1
AMG 404 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04885998 — Phase 1
~6 spots leftby Jul 2025