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Adding tarlatamab to durvalumab with carboplatin and etoposide for first-line extensive-stage small-cell lung cancer

A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in Combination With Durvalumab, Carboplatin and Etoposide Versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)

Phase 3 Interventional Amgen · NCT07005128

This trial tests whether adding tarlatamab to durvalumab plus carboplatin and etoposide helps people with newly diagnosed extensive-stage small-cell lung cancer live longer.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment330 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorAmgen Industry-sponsored
Drugs / interventionsdurvalumab, radiation, tarlatamab
Locations153 sites (Goodyear, Arizona and 152 other locations)
Trial IDNCT07005128 on ClinicalTrials.gov

What this trial studies

This phase 3 randomized trial compares tarlatamab combined with durvalumab and standard carboplatin/etoposide chemotherapy versus durvalumab with carboplatin/etoposide as first-line treatment for extensive-stage small-cell lung cancer. The primary endpoint is overall survival, and enrolled adults must have measurable disease and be suitable for the chemo-immunotherapy regimen. Key eligibility criteria include AJCC 2017 Stage IV disease, adequate organ function, no recent other malignancies, and no symptomatic central nervous system metastases. The study is being conducted at multiple U.S. cancer centers and is sponsored by Amgen with collaboration from AstraZeneca.

Who should consider this trial

Good fit: Adults with newly diagnosed extensive-stage small-cell lung cancer who have measurable disease and are able to receive carboplatin, etoposide, and durvalumab are the intended participants.

Not a fit: Patients with symptomatic brain metastases, recent other malignancies within two years, or a history of severe immune-mediated toxicity are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If effective, the combination could extend overall survival for patients with newly diagnosed extensive-stage small-cell lung cancer.

How similar studies have performed: Durvalumab and other PD-L1 inhibitors added to chemotherapy have improved outcomes in first-line ES-SCLC and early-phase data for tarlatamab showed promising activity in relapsed disease, but the specific combination of tarlatamab with PD-L1 blockade plus chemotherapy in the first-line setting is largely untested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participant has provided informed consent before initiation of any study-specific activities/procedures.
* Age ≥ 18 years or ≥ legal age within the country if it is older than 18 years.
* Histologically or cytologically documented ES-SCLC (American Joint Committee on Cancer, 2017, Stage IV SCLC \[T any, N any, M1 a/b/c\]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
* Measurable disease as defined per RECIST 1.1.
* Suitable to receive carboplatin, etoposide and durvalumab regimen as first-line treatment per investigator clinical assessment.
* Minimum life expectancy ≥ 12 weeks.

Exclusion Criteria:

* Participants can have no history of other malignancy in the last 2 years.
* Any symptomatic central nervous system (CNS) metastases, or leptomeningeal disease.
* They will have no history of severe or life-threatening events to immune-mediated therapy.
* History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.
* They will have no active autoimmune or inflammatory disorders.
* Presence of active human immunodeficiency virus (HIV) or active Hepatitis (B/C) infection.
* Evidence or interstitial lung disease (ILD) or active, non-infectious pneumonitis.
* History of solid organ transplant.
* They will not have had a myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 6 months prior to first dose of study treatment.

Where this trial is running

Goodyear, Arizona and 152 other locations

+103 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Small-cell Lung CancerExtensive Stage Small-cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.