Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

NCT07339059 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HFH-C-2025-02
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the combination of sacituzumab govetican (SG) and atezolizumab/durvalumab is effective in controlling cancer tumor growth in adults with extensive stage small cell lung cancer. These drugs are FDA approved individually in different cancers. This combination is evaluated in breast cancer and showed promising combination. The effectiveness of this treatment combination will be measured by changes in tumor size and appearance of new tumors. Participants in the trial will:

• receive treatment SG and immunotherapy every 21 days for up to 2 years or until it is no longer works for the patient.
• CT scans at 6weeks for first 6 cycles and then every 9-12 weeks and MRI brain every 12 weeks.
• provide tissue (optional) and blood for additional testing (learn about the cancer).

Conditions

Small Cell Lung Cancer ( SCLC ); Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Keywords

atezolizumab; durvalumab; sactizumab govetican; small cell lung cancer; sclc; es-sclc; lung cancer; extensive stage

Outcome Measures

Primary Outcomes (1)

• Disease Control

  To evaluate the rate of disease control at 12 weeks for patients with extensive stage small cell lung cancer treated with Sacituzumab govitecan (SG) plus atezolizumab or durvalumab as maintenance therapy after induction treatment with chemotherapy and immunotherapy. Disease Control at 12 weeks is defined as a best response by RECIST 1.1 of CR, PR, non-CR, non-PR, or stable disease assessed by RECIST 1.1 and reported within 12 weeks (+/- 2 weeks) from the initiation of study therapy. Participants not known to have disease control at 12 weeks will be coded as lacking disease control.

  12 weeks from study enrollment

Secondary Outcomes (3)

• Overall Survival

  Through study completion, an average of 1 year

• Progression Free Survival

  Through study completion, an average of 1 year

• Combination therapy toxicity

  Through study completion, an average of 1 year

Study Arms (1)

SG and atezolizumab/durvalumab

EXPERIMENTAL

Sacituzumab govitecan 10 mg/kg via IV infusion on Day 1 and Day 8 of a 21-day cycle (ie, 2 weekly doses plus 1 week without treatment) AND Atezolizumab 1200mg via IV infusion on Day 1 of a 21-day cycle (ie, once every 3 weeks) OR Sacituzumab govitecan 10 mg/kg via IV infusion on Day 1 and Day 8 of a 21-day cycle (ie, 2 weekly doses plus 1 week without treatment) AND Durvalumab 1500mg via IV infusion on Day 1 of a 21-day cycle (ie, once every 3 weeks)

Drug: Sacituzumab govitecan; Drug: Atezolizumab; Drug: Durvalumab

Interventions

Sacituzumab govitecan DRUG

Sacituzumab govitecan 10 mg/kg via IV infusion on Day 1 and Day 8 of a 21-day cycle (ie, 2 weekly doses plus 1 week without treatment)

Also known as: Trodelvy

SG and atezolizumab/durvalumab

Atezolizumab DRUG

Atezolizumab 1200mg via IV infusion on Day 1 of a 21-day cycle (ie, once every 3 weeks)

Also known as: Tecentriq

SG and atezolizumab/durvalumab

Durvalumab DRUG

Durvalumab 1500mg via IV infusion on Day 1 of a 21-day cycle (ie, once every 3 weeks)

Also known as: Imfinzi

SG and atezolizumab/durvalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the trial.
• Male or Female aged 18 years or above.
• Participants must have a histologically or cytologically confirmed diagnosis of small cell lung cancer (SCLC) and extensive stage at diagnosis or locally advanced disease and unable to receive curative intent radiation.
• Participants must have received at least four cycles of platinum plus etoposide and at least 2-3 cycles of atezolizumab/ Durvalumab.
• No evidence of progression on restaging CT CAP following 4-6 cycles of Chemo/IO from the last dose of the chemotherapy cycle.
• ECOG performance status of 0-2
• Patients must not have active uncontrolled HIV, HBV, and HCV infections. Well-controlled infections on treatment will be allowed to participate in the trial.
• Patients with stable and asymptomatic brain metastasis.
• Adequate organ function - bone marrow, kidney, and liver.

You may not qualify if:

• Significant renal impairment requiring dialysis or hepatic impairment with end-stage liver disease.
• Participants with leptomeningeal disease.
• Participants with a recent diagnosis of heart failure and acute coronary disease within 3 months.
• Participants who are unable to receive immunotherapy with chemotherapy for induction will be excluded, or those immunotherapy was discontinued to manage immune-related adverse events
• Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrolment.
• Patients with prior exposure to anti-PD-1, anti-PD-L1, or anti-PD-L2 agents or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4) within 12 months of the study is not allowed.

Sponsors & Collaborators

• Bindu R Potugari: lead
• Gilead Sciences: collaborator

Study Sites (1)

Henry Ford Cancer- Detroit

Detroit, Michigan, 48202, United States

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Lung Neoplasms

Interventions

sacituzumab govitecan; atezolizumab; durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Bindu Potugari, MD

CONTACT

888-734-5322; bpotuga1@hfhs.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Thoracic Oncologist

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: January 14, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-01

Locations

US (1)