Clinical trial · Expanded Access
Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer
A Phase 3b, Multicenter, Single-arm, Expanded Access Protocol of Tarlatamab (AMG 757) for the Treatment of Subjects With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment
NCT06064500CI-TRIAL-00086948approved for marketingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of the study is to provide expanded access to and characterize the safety profile of tarlatamab in participants with advanced small cell lung cancer (SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen). EA may still be available in countries outside of the United States.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tarlatamab | Drug | Tarlatamab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Histologically or cytologically confirmed SCLC * Extensive-stage, unable to be encompassed in a tolerable radiation plan * Progressed or recurred following 1 platinum-based regimen and at least 1 other prior line of therapy * Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1 * Minimum life expectancy of 12 weeks Exclusion Criteria: * Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology * Symptomatic central nervous system (CNS) metastases * Active hepatitis B or hepatitis C virus infection * Eligible for participation in any Amgen-sponsored ongoing clinical study of the investigational product * Currently or previously enrolled in a prior tarlatamab study * Female participants and/or male participants with female partners who are pregnant, breastfeeding, planning to become pregnant or donate eggs while on study through 60 days after the last dose of tarlatamab * Male and female participants unwilling to practice abstinence and/or use protocol specified method of contraception
References
Publications (0)
Data not yet available
No reference posted for this study.