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Comparing sacituzumab govitecan to standard care for advanced small cell lung cancer

A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Phase 3 Interventional Gilead Sciences · NCT06801834

This study is testing whether a new treatment called sacituzumab govitecan can help people with advanced small cell lung cancer live longer and feel better compared to standard care.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment695 (estimated)
Ages18 Years and up
SexAll
SponsorGilead Sciences Industry-sponsored
Drugs / interventionstarlatamab, chemotherapy, immunotherapy, prednisone, sacituzumab
Locations205 sites (Anaheim, California and 204 other locations)
Trial IDNCT06801834 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the effectiveness of sacituzumab govitecan (SG) compared to standard of care (SOC) treatments in patients with previously treated extensive stage small cell lung cancer (ES-SCLC). The primary focus is to assess the objective response rate (ORR) and overall survival (OS) of participants receiving SG versus those receiving SOC. Participants will be monitored through imaging techniques to determine disease progression and response to treatment. The study is designed to provide insights into the potential benefits of SG in this patient population.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed extensive stage small cell lung cancer who have experienced disease progression after prior platinum-based chemotherapy.

Not a fit: Patients who have not undergone at least one line of platinum-containing chemotherapy or those with a chemotherapy-free interval of less than 30 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new treatment option that improves response rates and survival for patients with advanced small cell lung cancer.

How similar studies have performed: Previous studies have shown promising results with similar approaches in treating small cell lung cancer, suggesting potential for success with this novel treatment.

Eligibility criteria

Show full inclusion / exclusion 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.
* Individuals treated with a platinum-based therapy for prior limited stage small cell lung cancer will be counted as 1 prior line of platinum-containing chemotherapy if the disease has progressed within 30 to 180 days from last dose of platinum treatment.
* If the investigator believes a participant may benefit from platinum rechallenge it can be considered per investigator discretion and local SOC; however, participants with platinum rechallenge may not participate in the study.
* If the investigator believes a participant may benefit from tarlatamab treatment, it can be considered per investigator discretion and local SOC and such participants may participate in the study following tarlatamab treatment.

Note: at least 85% of participants included in the study must be pretreated with anti-PD-\[L\]1 therapy.

Refer to protocol for country-specific requirements for participants in China.

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. 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Anaheim, California and 204 other locations

+155 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Extensive Stage Small Cell Lung Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.