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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Gilead Sciences Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

16 Jul 2025 → ongoing

Decision date (initial)

2025-05-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Safety, Efficacy, Therapy, Pharmacokinetic

1.To compare the effect of sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132) to standard of care (SOC) on objective response rate (ORR) as assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
2.To compare the effect of SG to SOC on overall survival (OS)

Secondary objectives 5

1. To compare the effect of SG to SOC on progression-free survival (PFS) as assessed by BICR according to RECIST v1.1
2. To compare the effect of SG to SOC on duration of response (DOR) as assessed by BICR according to RECIST v1.1
3. To compare the effect of SG to SOC on shortness of breath
4. To compare the effect of SG to SOC on physical functioning
5. To compare the safety and tolerability of SG to SOC

Conditions and MedDRA coding

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

EMA paediatric investigation plan (PIP)

EMEA-002645-PIP03-21

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Histologically confirmed diagnosis of SCLC.
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
3. Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria.
4. 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 (Note: at least 85% of participants included in the study must be pretreated with anti-PD-[L]1 therapy)

Exclusion criteria 3

1. 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).
2. Received any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I.
3. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 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
2. OS is defined as length of time from randomization until the date of death from any cause

Secondary endpoints 5

1. 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
2. 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
3. Time to first deterioration in shortness of breath
4. Time to first deterioration in physical functioning
5. Incidence of treatment-emergent adverse events (AEs) and clinical laboratory abnormalities

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gilead Sciences Inc.

Sponsor organisation

Gilead Sciences Inc.

Address

333 Lakeside Drive

City

Foster City

Postcode

94404-1147

Country

United States

Scientific contact point

Organisation

Gilead Sciences Inc.

Contact name

EU CT Support

Public contact point

Organisation

Gilead Sciences Inc.

Contact name

EU CT Support

Third parties 8

Locations

11 EU/EEA countries · 91 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 229 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

18 submissions — initial application plus substantial / non-substantial modifications