Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Conditions
Brief summary
The goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC). The primary objectives of this study are to compare the effect of SG to SOC on objective response rate (ORR) as assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumors and to compare the effect of SG to SOC on overall survival (OS).
Interventions
Administered intravenously
DRUGTopotecan
Administered intravenously
DRUGAmrubicin (Japan only)
Administered intravenously
Sponsors
Gilead Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Histologically confirmed diagnosis of SCLC. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria. * Documentation of radiological disease progression after 1 prior line of platinum-containing chemotherapy (defined as at least 2 cycles of treatment) with or without therapy directed against programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1; PD-1 and PD-L1 are hereafter referred to as PD-(L)1) for ES-SCLC. Key
Exclusion criteria
* Chemotherapy-free interval (CTFI) time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease) \< 30 days (independent of the immunotherapy maintenance). * Received any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I. * Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable CNS disease (ie, without evidence of progression) for at least 4 weeks prior to enrollment and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking ≤ 10 mg/day of prednisone or its equivalent. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to 4.5 years | ORR is defined as the percentage of participants who have achieved a complete response (CR) or partial response (PR) as assessed by BICR according to RECIST v1.1 |
| Overall Survival (OS) | Up to 4.5 years | OS is defined as length of time from randomization until the date of death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | Up to 4.5 years | PFS is defined as the time from date of randomization until disease progression as assessed by BICR according to RECIST v1.1 or death from any cause, whichever comes first. |
| Duration of Response (DOR) | Up to 4.5 years | DOR is defined as is measured from the time of first response (CR or PR) as assessed by BICR according to RECIST v1.1, until the date of first documented disease progression or death, whichever comes first |
| Time to First Deterioration in Shortness of Breath Domain | Up to 4.5 years | Time to first deterioration is defined as the time from the date of randomization to the first time a participant experienced change from baseline equal to or greater than the prespecified threshold value for deterioration or death. |
| Time to First Deterioration in Physical Functioning Domain | Up to 4.5 years | Time to first deterioration is defined as the time from the date of randomization to the first time a participant experienced change from baseline equal to or greater than the prespecified threshold value for deterioration or death. |
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | First dose date up to 4.5 years | TEAE is defined as any AEs occurred during the treatment-emergent period. The treatment-emergent period is defined as the time period from the first dose of study treatment to the earlier of 30 days following the last dose of study treatment or the initiation of subsequent anticancer therapy. |
| Percentage of Participants Experiencing Clinical Laboratory abnormalities | First dose date up to 4.5 years | Laboratory abnormality is defined as any value that increases at least 1 toxicity grade from baseline. |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, France, Germany, Greece, Hungary, Israel, Italy, Japan, Malaysia, Netherlands, Norway, Poland, Romania, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
CONTACTGilead Clinical Study Information Cente
STUDY_DIRECTORGilead Study Director
Gilead Sciences
Outcome results
None listed