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
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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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