EUCTR2021-002566-40-GR
Active, not recruiting
Phase 1
A Phase 2 Study Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects with Relapsed/Refractory Small Cell Lung Cancer After Two or More Prior Lines of Treatment
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Relapsed/Refractory Small Cell Lung Cancer
- Sponsor
- Amgen Inc.
- Enrollment
- 160
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •101 Subject has provided informed consent/assent prior to initiation of
- •specific activities/procedures.
- •102 Male and female subjects \>\= 18 years of age (or legal adult age
- •within country) at the time of signing the informed consent.
- •103 Histologically or cytologically confirmed relapsed/refractory SCLC
- •104 Subjects who progressed or recurred following 1 platinum\-based
- •regimen and at least 1 other prior line of therapy
- •Note: (1\) re\-treatment with a platinum\-based regimen is considered a second line of therapy; (2\) platinum\-based regimen followed by
- •checkpoint inhibitor/anti\-programmed death ligand 1 (PD\-L1\) as
- •maintenance therapy is considered 1 line of therapy; (3\) in countries
Exclusion Criteria
- •Disease Related
- •201 Untreated or symptomatic brain metastases and leptomeningeal
- •202 Has evidence of interstitial lung disease or active, non\-infectious
- •pneumonitis.
- •203 Subjects who experienced recurrent pneumonitis (grade 2 or
- •higher) or severe, life\-threatening immune\-mediated adverse events or
- •infusion\-related reactions including those that lead to permanent
- •discontinuation while on treatment with immuno\-oncology agents.
- •204 Unresolved toxicity from prior anti\-tumor therapy, defined as not
- •having resolved to Common Terminology Criteria for Adverse Events
Outcomes
Primary Outcomes
Not specified
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