NCT07339059 Study of Sacituzumab Govitecan With Atezolizumab/Durvalumab as Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer
| NCT ID | NCT07339059 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Bindu R Potugari |
| Condition | Small Cell Lung Cancer ( SCLC ) |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2029-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 35 participants in total. It began in 2026-06-01 with a primary completion date of 2029-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07339059 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Small Cell Lung Cancer ( SCLC ). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07339059 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07339059 currently recruiting?
Yes, NCT07339059 is actively recruiting participants. Contact the research team at bpotuga1@hfhs.org for enrollment information.
Where is the NCT07339059 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT07339059 clinical trial?
NCT07339059 is sponsored by Bindu R Potugari. The trial plans to enroll 35 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.