Study on Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

Sponsor: Amgen

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06117774

This clinical trial is testing whether the drug tarlatamab can help patients with limited-stage small-cell lung cancer (LS-SCLC) live longer without the cancer getting worse, compared to a placebo.

Patient Parameters

Program Overview

The main goal of this study is to see if tarlatamab can help patients with limited-stage small-cell lung cancer (LS-SCLC) live longer without their cancer progressing, compared to those who receive a placebo. Participants will have already completed chemotherapy and radiotherapy for their cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have confirmed small-cell lung cancer (SCLC).
  • Have been diagnosed and treated for limited-stage SCLC with both chemotherapy and radiotherapy.
  • Completed treatment without the cancer getting worse.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 12 weeks.
  • Have adequate organ function.
  • Any side effects from previous treatment should be mild or resolved, except for hair loss or fatigue.

Exclusion Criteria

  • Have extensive-stage SCLC or other types of lung cancer.
  • Have lung diseases like interstitial lung disease or active pneumonitis.
  • Have had another cancer in the past 2 years, with some exceptions.
  • Have had a solid organ transplant.
  • Have had a heart attack or severe heart failure in the past 6 months.
  • Have had a stroke or similar event in the past 6 months.
  • Have active infections or certain viral infections like HIV or hepatitis.
  • Have received certain types of chemotherapy and radiotherapy separately.
  • Have had previous treatment targeting the DLL3 pathway.
  • Have had severe reactions to immune therapies.
  • Are currently receiving other cancer treatments, except for certain hormonal therapies.
  • Are taking steroids or other immune-suppressing drugs recently.
  • Have had major surgery in the past 28 days.
  • Have had live vaccines recently.
  • Are participating in another clinical trial.
  • Women who are pregnant, breastfeeding, or planning to become pregnant.
  • Men with partners who are pregnant or could become pregnant, unless using contraception.
  • Have allergies to study drugs.
  • Are unable to attend all study visits or follow study procedures.
  • Have any other significant health issues that could affect participation.

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