Recruiting
Phase 2

SG & Atezolizumab/Durvalumab

Sponsor:

Bindu R Potugari

Code:

NCT07339059

Conditions

Small Cell Lung Cancer ( SCLC )

Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sacituzumab govitecan

Atezolizumab

Durvalumab

Study Details

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)

Study ID

NCT07339059

Start date

May 14, 2026

Status verified date

Jan, 2026

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Feb 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SG and atezolizumab/durvalumab

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)

Interventions

Sacituzumab govitecan

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)

Atezolizumab

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

Durvalumab

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

Primary outcome measure

  • Disease Control [ Time Frame: 12 weeks from study enrollment ]

Central Contacts and Locations

Central contacts

Bindu Potugari, MD

888-734-5322bpotuga1@hfhs.org

Locations

Henry Ford Cancer- Detroit

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Bethany Adams, RN

313.556.8107badams19@hfhs.org

More Information

Sponsor

Bindu R Potugari

Last update posted

Jul 28, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bindu R Potugari on 2026-07-28.