Phase 2a Study Evaluating the Efficacy, Safety, Tolerability and Pharmacokinetics of Tarlatamab in Chinese Subjects With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment (DeLLphi-307)
Overview
- Phase
- Phase 2
- Intervention
- Tarlatamab
- Conditions
- Not specified
- Sponsor
- Amgen
- Enrollment
- 32
- Locations
- 23
- Primary Endpoint
- ORR Based on BICR per RECIST 1.1
- Status
- Active, not recruiting
- Last Updated
- 17 days ago
Overview
Brief Summary
The primary aim of this study is to evaluate the efficacy of tarlatamab as assessed by objective response rate (ORR) based on blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant has provided informed consent prior to initiation of any study specific activities/procedures.
- •Participant must be a resident in China, and of Chinese ancestry ≥ 18 years of age (or legal adult age within country) at the time of signing the informed consent.
- •Histologically or cytologically confirmed small cell lung cancer.
- •Extensive-stage SCLC participants who progressed on or recurred following 1 platinum-based regimen as 1L therapy (including a PD-1/PD-\[L\]1) and at least 1 other prior line of therapy.
- •Measurable lesions as defined per RECIST 1.1 within 21 days prior to the first dose of study drug.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Minimum life expectancy of 12 weeks.
- •Adequate organ function.
Exclusion Criteria
- •Disease Related
- •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.
- •Symptomatic central nervous system (CNS) metastases.
- •Diagnosis or evidence of leptomeningeal disease.
- •Prior history of severe or life-threatening events from any immune-mediated therapy.
- •Other Medical Conditions
- •Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study.
- •History of solid organ transplantation.
- •Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- •History of other malignancy within the past 2 years, with certain exceptions
Arms & Interventions
Tarlatamab
Participants will receive tarlatamab as an intravenous (IV) infusions in 28-day cycles.
Intervention: Tarlatamab
Outcomes
Primary Outcomes
ORR Based on BICR per RECIST 1.1
Time Frame: Approximately 24 months
Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Time Frame: From first dose of trial drug up to a minimum of last dose + 65 days or data cutoff date; median (min, max) time on trial was 3.4 (2.2, 6.5) months at data cut off
ORR based on BICR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) plus partial response (PR). CR: Disappearance of all target non-nodal lesions. Any target lymph node must have had a reduction in short axis to \<10 mm, NOT total disappearance. PR: At least a 30% decrease in the sum of the diameters of target lesions, taken as reference the baseline sum of diameters. The percentage of participants who experience a CR or PR as assessed by BICR based on RECIST 1.1 is presented.
Secondary Outcomes
- Duration of Response (DOR) Based on BICR per RECIST 1.1(Approximately 24 months)
- Disease Control (DC) Based on BICR per RECIST 1.1(Approximately 24 months)
- Duration of DC Based on BICR per RECIST 1.1(Approximately 24 months)
- Progression-free Survival (PFS) Based on BICR per RECIST 1.1(Approximately 24 months)
- ORR Based on Investigator Assessment per RECIST 1.1(Approximately 24 months)
- DOR Based on Investigator Assessment per RECIST 1.1(Approximately 24 months)
- DC Based on Investigator Assessment per RECIST 1.1(Approximately 24 months)
- Duration of DC Based on Investigator Assessment per RECIST 1.1(Approximately 24 months)
- PFS Based on Investigator Assessment per RECIST 1.1(Approximately 24 months)
- Serum Concentration of Tarlatamab(Approximately 24 months)
- Number of Participants with Anti-tarlatamab Antibody Formation(Approximately 24 months)
- Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs)(Approximately 24 months)
- Overall Survival (OS)(Approximately 24 months)
- Duration of Response (DOR) Based on BICR Per RECIST 1.1(Approximately 24 months)
- Disease Control (DC) Based on BICR Per RECIST 1.1(Approximately 24 months)
- Duration of DC Based on BICR Per RECIST 1.1(Approximately 24 months)
- Progression-free Survival (PFS) Based on BICR Per RECIST 1.1(Approximately 24 months)
- ORR Based on Investigator Assessment Per RECIST 1.1(Approximately 24 months)
- DOR Based on Investigator Assessment Per RECIST 1.1(Approximately 24 months)
- DC Based on Investigator Assessment Per RECIST 1.1(Approximately 24 months)
- Duration of DC Based on Investigator Assessment Per RECIST 1.1(Approximately24 months)
- PFS Based on Investigator Assessment Per RECIST 1.1(Approximately 24 months)
- Trough Concentration (Ctrough) of Tarlatamab(Approximately 24 months)
- Number of Participants With Anti-tarlatamab Antibodies Formation(Approximately 24 months)