Recruitment Complete
Sponsor ID
20200041

Study Comparing Tarlatamab and Durvalumab versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and DurvalumabDeLLphi-305

Sponsor ID
20200041
Clinicaltrials.gov ID
NCT06211036
EUCTIS ID
2023-505989-29
EudraCT ID
N/A

Study Details

The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).

Additional Study Details

Phase
Phase 3
Product
Tarlatamab
Type
Interventional
Masking
None (Open Label)
Enrollment
563
Additional Study Details

Protocol Summary

Primary Outcome Measures

OS

Timeframe: Up to approximately 3 years

Secondary Outcome Measures

Progression Free Survival (PFS)

Timeframe: Up to approximately 3 years

Overall Response (OR)

Timeframe: Up to approximately 3 years

Disease Control (DC) Rate

Timeframe: Up to approximately 3 years

Duration of Response (DoR)

Timeframe: Up to approximately 3 years

PFS at 6 Months

Timeframe: 6 months

PFS at 1 Year

Timeframe: 1 year

PFS at 2 Years

Timeframe: 2 years

OS at 6 Months

Timeframe: 6 months

OS at 1 Year

Timeframe: 1 year

OS at 2 Years

Timeframe: 2 years

OS at 3 Years

Timeframe: 3 years

Time to Progression (TTP)

Timeframe: Up to approximately 3 years

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to approximately 9 months

Number of Participants with TEAEs Grade 3 or Above per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.

Timeframe: Up to approximately 3 years

Number of Participants with Serious TEAEs

Timeframe: Up to approximately 3 years

Number of Participants with TEAEs Leading to Discontinuation of Treatment

Timeframe: Up to approximately 3 years

Number of Participants with Fatal TEAEs

Timeframe: Up to approximately 3 years

Number of Participants with Treatment-related Adverse Events (AEs)

Timeframe: Up to approximately 9 months

Number of Participants with Adverse Events of Interest (EOI)

Timeframe: Up to approximately 9 months

Serum Concentrations of Tarlatamab

Timeframe: Day 1 up to approximately 6 months

Number of Participants with Antitarlatamab Antibody Formation

Timeframe: Up to approximately 9 months

Time to First Deterioration (TTD) for Physical Function as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC-QLQ-C30)

Timeframe: Up to approximately 9 months

Change in Disease Symptoms of Cough as Measured Using EORTC-QLQ LC13

Timeframe: Up to 12 months

Change in Disease Symptoms of Chest Pain as Measured Using EORTC-QLQ LC13

Timeframe: Up to 12 months

Change in Disease Symptoms of Dyspnea as Measured Using EORTC-QLQ LC13

Timeframe: Up to 12 months

TTD for Global Health Status as Measured by EORTC-QLQ-C30

Timeframe: Up to approximately 9 months

TTD for Quality of Life as Measured by EORTC-QLQ-C30

Timeframe: Up to approximately 9 months

Locations

Location
Status
Contact Us
Location
Jilin Cancer Hospital
Changchun, Jilin, China, 130012
Status
Recruiting
Location
Kurume University Hospital
Kurume-shi, Fukuoka, Japan, 830-0011
Status
Recruiting
Location
Universitaetsspital Basel
Basel, Switzerland, 4052
Status
Recruiting
Location
Nebraska Cancer Specialists
Omaha, NE, United States, 68130
Status
Terminated
Location
Northeast Georgia Medical Center
Gainsville, GA, United States, 30501
Status
Terminated
Location
Baptist Cancer Center Memphis Thoracic
Memphis, TN, United States, 38120
Status
Recruiting
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