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Tarlatamab and Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer

NCT07637513 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2026-06-09

No results posted yet for this study

Summary

Eligible participants with limited stage-small cell lung cancer (LS-SCLC) will be enrolled after completion of chemotherapy and radiation. Participants will be randomized to either tarlatamab in combination with durvalumab or durvalumab alone as consolidation therapy. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent.

Tarlatamab is a targeted cancer treatment. It works by acting as a matchmaker between the immune system's T-cells and the cancer cells, forcing them to come together so the T-cells can attack the cancer.

Image testing will be done standardly during treatment. These tests show whether the cancer has progressed and if further treatment may be needed.

The purpose of this trial is to evaluate how well the treatment works (how long before your cancer comes back and how long you live).

Conditions

  • Limited Stage Small-Cell Lung Cancer

Interventions

DRUG

Tarlatamab

Tarlatamab Intravenous (IV): Cycle 1 Step Dose: Day 1- 1 mg; Day 8- 10 mg; Day 15- 10 mg of a 28-day cycle, then Cycle 2 and Subsequent Cycles: Day 1- 10 mg and Day 15- 10 mg every 28-day cycle up to 12 months from cycle 1 day 1 unless other treatment discontinuation or rechallenge criteria are met.

DRUG

Durvalumab

Durvalumab 1500 mg IV: Every 4 weeks until disease progression, unacceptable toxicity, or a maximum of 24 months from cycle 1 day 1, unless other treatment discontinuation criteria are met.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • PrECOG, LLC.

    lead OTHER

Principal Investigators

  • Ryan Gentzler, MD, MS · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2037-11-30
Completion
2038-06-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07637513 on ClinicalTrials.gov