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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Alaska Oncology and Hematology
  Anchorage, Alaska, United States Recruiting
• Genesis Cancer and Blood Institute
  Hot Springs, Arkansas, United States Recruiting
• Los Angeles Cancer Network
  Anaheim, California, United States Recruiting
• Boca Raton Regional
  Miami, Florida, United States Recruiting
• Hope and Healing Cancer Services
  Hinsdale, Illinois, United States Recruiting
• Southern Illinois University School of Medicine
  Springfield, Illinois, United States Recruiting

+169 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Gilead Clinical Study Information Cente
• Email: GileadClinicalTrials@gilead.com
• Phone: 1-833-445-3230 (GILEAD-0)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Sacituzumab Tirumotecan plus Pembrolizumab in advanced biliary tract cancer

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  Recruiting Phase 2 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07850791

• Sac-TMT and pembrolizumab with chemoradiation for bladder muscle invasion

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  Recruiting at 10 sites Phase 3 Merck Sharp & Dohme LLC · Kaohsiung City and 9 other locations · NCT07829783

• Sacituzumab Govitecan plus Tislelizumab for advanced esophageal cancer

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  Recruiting at 2 sites Phase 2 Shanghai Chest Hospital · Shanghai and 1 other locations · NCT07811752

• MK-2010 with Sac-TMT in advanced solid tumors

  This study tests MK-2010 combined with sacituzumab tirumotecan (sac-TMT) to see if it can help people with advanced solid tumors.

  Recruiting at 4 sites Phase 2 Merck Sharp & Dohme LLC · San Antonio, Texas and 3 other locations · NCT07785609

• Metronomic oral paclitaxel with PD-1/PD-L1 inhibitor maintenance in advanced lung cancer

  This trial tests whether taking low, regular doses of oral paclitaxel plus a PD-1 or PD-L1 inhibitor as maintenance therapy can help people with advanced sqNSCLC or ES-SCLC who did not progress after first-line chemo-immunotherapy.

  Recruiting Phase 4 Anhui Provincial Cancer Hospital · Hefei, Anhui · NCT07744698

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.