Expanded Access to Tarlatamab for Advanced Small Cell Lung Cancer

Sponsor: Amgen

Expanded Access
Approved for Marketing
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06064500

Provider View

This program offers access to the drug tarlatamab for patients with advanced small cell lung cancer (SCLC) who have already tried at least two treatments, including one platinum-based therapy. The program is available in some countries outside the United States.

Patient Parameters

Program Overview

The main goal of this program is to provide access to tarlatamab for patients with advanced small cell lung cancer (SCLC) who have already undergone two or more treatments, including at least one platinum-based therapy. This program is available in certain countries outside the United States and aims to monitor the safety of tarlatamab in these patients.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of small cell lung cancer (SCLC).
  • Have extensive-stage SCLC that cannot be treated with radiation.
  • Cancer must have worsened or returned after receiving one platinum-based treatment and at least one other therapy.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 12 weeks.

Exclusion Criteria

  • Have a history of non-small cell lung cancer (NSCLC) that has changed to SCLC or mixed types of lung cancer.
  • Have untreated or symptomatic cancer that has spread to the brain or spinal cord.
  • Have active hepatitis B or C infections.
  • Be eligible for any ongoing Amgen-sponsored clinical study involving tarlatamab.
  • Have participated in a previous study involving tarlatamab.
  • Female participants who are pregnant, breastfeeding, planning to become pregnant, or donate eggs during the study and for 72 days after the last dose.
  • Male and female participants who are not willing to use effective birth control methods or abstain from sex during the study.

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