Phase 3 Study of Tarlatamab (Injection vs IV) for Extensive-Stage Small Cell Lung Cancer After Initial Chemotherapy

Sponsor: Amgen

Sponsor score: 60

ClinicalTrials ID:NCT07778316

Provider View

This clinical trial is comparing two ways of giving the drug Tarlatamab—injection under the skin versus through an IV—to see if they work equally well for patients with extensive-stage small cell lung cancer that has returned after initial chemotherapy.

Patient Parameters

Program Overview

The main goal of this study is to see if giving Tarlatamab as an injection under the skin is as effective as giving it through an IV for patients with extensive-stage small cell lung cancer (ES-SCLC) that has come back after platinum-based chemotherapy. The study will also look at how well the injection works, how safe it is, and how well patients can tolerate it.

Eligibility Criteria

Inclusion Criteria

  • Must provide consent before starting any study activities.
  • Be 18 years or older.
  • Have a confirmed diagnosis of small cell lung cancer that has progressed or returned.
  • Cancer must have come back after one round of platinum-based chemotherapy.
  • Have measurable cancer as per standard criteria within 21 days before starting the study.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have a life expectancy of at least 12 weeks.
  • Have adequate organ function.
  • History of brain metastases is allowed under certain conditions.

Exclusion Criteria

  • Have a history of non-small cell lung cancer or certain genetic mutations that have changed to small cell lung cancer.
  • Have had a heart attack or severe heart failure within the last 6 months.
  • Have had a stroke or similar event within the last 6 months.
  • Have lung diseases that required treatment with steroids or other immune-suppressing drugs.
  • Have had another cancer in the past 2 years, with some exceptions.
  • Have certain viral infections as defined by the study.
  • Have had an organ transplant.
  • Have an active infection needing antibiotics within 7 days before starting the study.
  • Have allergies to any study drugs or components.
  • Have uncontrolled fluid buildup around the lungs, heart, or abdomen.
  • Have had cancer treatment within 30 days before joining the study.
  • Have had severe reactions to immune therapies.
  • Are taking steroids or immune-suppressing drugs within 14 days before starting the study.
  • Have had live vaccines within 28 days before starting the study.
  • Are receiving treatment for another type of cancer.
  • Have had more than one previous treatment for small cell lung cancer.
  • Have participated in a Tarlatamab trial or taken similar drugs before.
  • Have been in another investigational trial within 28 days before joining.
  • Have allergies to similar drugs or components.
  • Cannot receive injections in the abdomen or thigh.
  • Cannot complete all study procedures or requirements.
  • Have any other significant health issues that could pose a risk.

Locations

FACILITYZIPCITYSTATE
Cancer and Hematology Centers of Western Michigan49503Grand RapidsMichigan

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