Recruitment Complete
Sponsor ID
20210004

Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung CancerDeLLphi-304

Sponsor ID
20210004
Clinicaltrials.gov ID
NCT05740566
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The main objective is to compare the efficacy of tarlatamab with standard of care (SOC) on prolonging overall survival (OS).

Additional Study Details

Phase
Phase 3
Product
Tarlatamab
Type
Interventional
Masking
None (Open Label)
Enrollment
509
Additional Study Details

Protocol Summary

Primary Outcome Measures

Overall Survival (OS)

Timeframe: Up to approximately 4 years

Secondary Outcome Measures

Progression Free Survival (PFS)

Timeframe: Up to approximately 4 years

Change from Baseline In Selected Functional Scales and Disease Symptom Items Included in Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

Timeframe: Up to approximately 4 years

Change from Baseline in Selected Disease Symptoms Included in Lung Cancer Quality of Life Questionnaire (EORTC-QLQ-LC13)

Timeframe: Up to approximately 4 years

Overall Response (OR)

Timeframe: Up to approximately 4 years

Disease Control (DC)

Timeframe: Up to approximately 4 years

Duration of Response (DOR)

Timeframe: Up to approximately 4 years

PFS

Timeframe: 1 year

OS

Timeframe: 1 year, 2 years and 3 years

Incidence of Treatment-Emergent Adverse Events (TEAE)

Timeframe: Up to approximately 4 years

Serum Concentrations of Tarlatamab

Timeframe: Up to 1 year

Number of Participants Who Experience Anti-tarlatamab Antibodies

Timeframe: Up to 1 year

Change from Baseline in Pain Severity as Measured by Brief Pain Inventory - Short Form (BPI-SF)

Timeframe: Up to approximately 4 years

Patient Perceived Health at Each Assessment Visit Using Visual Analogue Scale (VAS)

Timeframe: Up to approximately 4 years

Change from Baseline in Patient Perceived Health Using Visual Analog Scale (VAS)

Timeframe: Up to approximately 4 years

Responses to Patient-Reported Adverse Events Questionnaire (PRO-CTCAE)

Timeframe: Up to approximately 4 years

Change from Baseline in Symptom Severity as Measured by Patient Global Impression of Severity (PGIS) Questionnaire

Timeframe: Up to approximately 4 years

Change from Baseline in Symptoms and Overall Status as Measured by Patient Reported Impression of Change (PGIC) Questionnaire

Timeframe: Up to approximately 4 years

Change from Baseline in Symptom Bother as Measured by Functional Assessment of Cancer Therapy - General (FACT-G) Questionnaire

Timeframe: Up to approximately 4 years

Locations

Location
Status
Contact Us
Location
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, Turkey, 35575
Status
Recruiting
Location
Memorial Ankara Hastanesi
Ankara, Turkey, 06520
Status
Recruiting
Location
Ulsan University Hospital
Ulsan, Republic of Korea, 44033
Status
Recruiting
Location
Gyeongsang National University Hospital
Jinju-si, Republic of Korea, 52727
Status
Recruiting
Location
Chungbuk National University Hospital
Cheongju Chungbuk, Republic of Korea, 28644
Status
Recruiting
Location
Baptist Cancer Center
Memphis, TN, United States, 38120
Status
Recruiting
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