Clinical Trials Logo
  1. Home
  2. Small Cell Lung Cancer
  3. NCT06064500
  4. Details
NCT06064500 Clinical Trial

Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer

Small Cell Lung Cancer Clinical Trial

Official title:
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

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT06064500
Other study ID # 20220100
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date June 2024
Source Amgen
Contact Amgen Call Center
Phone 866-572-6436
Email medinfo@amgen.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 - Untreated or 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 72 days after the last dose of tarlatamab - Male and female participants unwilling to practice abstinence and/or use protocol specified method of contraception

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tarlatamab
Tarlatamab will be administered as a 60-minute intravenous infusion with 1 mg step dose on cycle 1 day 1 followed by a 10 mg target dose on cycle 1 day 8 and cycle 1 day 15 in a 28-day cycle. Subsequent doses (10 mg) will be administered every 2 weeks.

Locations
Country Name City State
Brazil Associacao Hospitalar Moinhos de Vento Porto Alegre Rio Grande Do Sul
Brazil Sociedade Beneficente de Senhoras Hospital Sirio Libanes Sao Paulo São Paulo
Japan Okayama University Hospital Okayama-shi Okayama
United States The University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States University of Virginia Charlottesville Virginia
United States Mount Sinai Comprehensive Cancer Center Miami Beach Florida
United States Yale School of Medicine New Haven Connecticut
United States Perlmutter Cancer Center at New York University Langone Hospital - 34th Street New York New York
United States Nebraska Cancer Specialists Omaha Nebraska
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Cancer Care Northwest - South Spokane Washington
United States Martin Memorial Health System Stuart Florida

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Brazil,  Japan, 

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03651219 - Mesylate Apatinib Combined With Irinotecan in Treatment of Recurrent Small Cell Lung Cancer Phase 3
Active, not recruiting NCT03958045 - Combination Rucaparib With Nivolumab in Small Cell Lung Carcinoma Phase 2
Completed NCT04381910 - Irinotecan Hydrochloride Liposome Injection (LY01610) For Small Cell Lung Cancer Phase 2
Active, not recruiting NCT04885998 - AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC) Phase 1
Active, not recruiting NCT03703297 - Study of Durvalumab + Tremelimumab, Durvalumab, and Placebo in Limited Stage Small-Cell Lung Cancer in Patients Who Have Not Progressed Following Concurrent Chemoradiation Therapy Phase 3
Recruiting NCT05903092 - MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer Phase 2
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Terminated NCT04422210 - A Study Evaluating The Safety, Tolerability, Pharmacokinetics, And Efficacy Of Venetoclax In Combination With Atezolizumab, Carboplatin, And Etoposide In Participants With Untreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC). Phase 1
Not yet recruiting NCT02875457 - Apatinib as the Maintenance Therapy for Extensive Stage Small Cell Lung Cancer After Combined With Etoposide/Cisplatin Phase 3
Recruiting NCT02577627 - Multi-Indication, Retrospective Oncological Study to Validate the Accuracy in Predicting TTP by PrediCare in Patients Under SOC N/A
Recruiting NCT02605811 - Temozolomide in Preventing Brain Metastases in Small Cell Lung Cancer Phase 2
Completed NCT02551432 - Pembrolizumab and Paclitaxel in Refractory Small Cell Lung Cancer Phase 2
Withdrawn NCT02542137 - Abscopal Effect for Metastatic Small Cell Lung Cancer Phase 2
Recruiting NCT02262897 - The Efficacy and Safety of Nab-paclitaxel in Pretreated Patients With Extensive Disease of Small Cell Lung Cancer Phase 2
Completed NCT01943578 - Value of Physical Capacity Tests in Lung Cancer N/A
Completed NCT01831089 - Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors Phase 1
Terminated NCT00969306 - Chloroquine as an Anti-Autophagy Drug in Stage IV Small Cell Lung Cancer (SCLC) Patients Phase 1
Completed NCT01497873 - A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer Phase 2
Completed NCT00930891 - Bevacizumab in Extensive Small Cell Lung Cancer Phase 2/Phase 3
Terminated NCT00958022 - Carboplatin and Etoposide Plus LBH589 for Small Cell Lung Cancer Phase 1

External Links