Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorGilead Sciences

About this trial

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 overall survival (OS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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. Received lurbinectedin after progression on or after platinum-based chemotherapy.

Have carcinomatous meningitis and/or non-carcinomatous meningitis central nervous system (CNS) metastasis apart from the following noted exceptions. Participants with previously treated brain metastases may participate provided they have stable CNS disease (ie, without evidence of progression) for at least 4 weeks (independent from completion of definitive treatment) prior to randomization 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. Participants with untreated, clinically stable brain metastases will be allowed if they are asymptomatic and the investigator determines there is no immediate CNS-specific treatment required, there is no surrounding edema, and the brain metastases are of 5 mm or less in size and 3 or fewer lesions.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sacituzumab Govitecan (SG)

    Drug

    Administered intravenously

  • Topotecan

    Drug

    Administered intravenously

  • Amrubicin (Japan only)

    Drug

    Administered intravenously

  • Lurbinectedin (regions/countries where approved and available)

    Drug

    Administered intravenously

Treatment groups

695 Participants
are divided into 2 treatment groups
Group A: Treatment Group A: SGExperimental treatment 1 intervention
Group B: Treatment Group B: Topotecan, or Lurbinectedin, or AmrubicinExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

OS is defined as length of time from randomization until the date of death from any cause.

Time frame
Up to 4.5 years

Secondary outcomes

1

Progression-free Survival (PFS)

PFS is defined as the time from date of randomization until disease progression as assessed by investigator according to RECIST v1.1 or death from any cause, whichever comes first.

Time frame
Up to 4.5 years
2

Objective Response Rate (ORR)

ORR is defined as the percentage of participants who have achieved a CR or PR as assessed by investigator according to RECIST v1.1.

Time frame
Up to 4.5 years
3

Duration of Response (DOR)

DOR is defined as is measured from the time of first response (CR or PR) as assessed by investigator according to RECIST v1.1, until the date of first documented disease progression or death, whichever comes first

Time frame
Up to 4.5 years
4

Time to First Deterioration in Shortness of Breath Domain

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 frame
Up to 4.5 years

Other outcomes

Sponsors and contacts

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