Recruitment Complete
Sponsor ID
20230016

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)DeLLphi-306

Sponsor ID
20230016
Clinicaltrials.gov ID
NCT06117774
EUCTIS ID
2023-506235-15
EudraCT ID
N/A

Study Details

The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS) based on blinded independent central review (BCIR) per response evaluation criteria in solid tumors v1.1 (RECIST 1.1) and on prolonging overall survival (OS).

Additional Study Details

Phase
Phase 3
Product
Tarlatamab
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
404
Additional Study Details

Protocol Summary

Primary Outcome Measures

PFS as Determined by BICR

Timeframe: Up to approximately 6 years

OS Over the Whole Trial

Timeframe: Up to approximately 6 years

Secondary Outcome Measures

PFS Determined by Investigator Assessment

Timeframe: Up to approximately 6 years

Complete Response (CR) Rate

Timeframe: Up to approximately 6 years

CR + non-CR/non-Progressive Disease (PD) Rate

Timeframe: Up to approximately 6 years

Duration of Complete Response

Timeframe: Up to approximately 6 years

PFS at 6 months, 1 year, 2 years

Timeframe: 6 months, 1 year, 2 years

OS at 6 months, 1 year, 2 years, 3 years

Timeframe: 6 months, 1 year, 2 years, 3 years

Time to Progression (TTP)

Timeframe: Up to approximately 6 years

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

Timeframe: Up to approximately 6 years

Serum Concentration of Tarlatamab

Timeframe: Up to approximately 4 months

Incidence of Anti-tarlatamab Antibody Formation

Timeframe: Up to approximately 1 year

Locations

Location
Status
Contact Us
Location
Kindai University Hospital
Osakasayama-shi, Osaka, Japan, 589-8511
Status
Recruiting
Location
Kurume University Hospital
Kurume-shi, Fukuoka, Japan, 830-0011
Status
Recruiting
Location
Sendai Kousei Hospital
Sendai-shi, Miyagi, Japan, 981-0914
Status
Recruiting
Location
National Hospital Organization Nagoya Medical Center
Nagoya-shi, Aichi, Japan, 460-0001
Status
Recruiting
Location
Taipei Veterans General Hospital
Taipei, Taipei, Taiwan, 11217
Status
Recruiting
Location
Chungbuk National University Hospital
Cheongju Chungbuk, Republic of Korea, 28644
Status
Recruiting
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