SG + Immunotherapy for Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a combination of two cancer treatments, sacituzumab govitecan (SG, an antibody-drug conjugate) and atezolizumab or durvalumab (both immunotherapy drugs), can effectively control tumor growth in people with extensive stage small cell lung cancer. Both drugs are already used individually to treat other types of cancer and have shown promise when combined in breast cancer studies. Participants will receive these treatments every 21 days for up to two years, with regular scans to monitor tumor changes. Candidates may be suitable if they have extensive stage small cell lung cancer, have completed certain chemotherapy cycles without disease progression, and have stable brain metastasis (cancer spread to the brain that is not causing symptoms). As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that well-controlled infections on treatment are allowed, suggesting some medications might be continued. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that combining sacituzumab govitecan (SG) with immunotherapy drugs like atezolizumab or durvalumab is generally safe. In previous studies, patients with extensive-stage small cell lung cancer (ES-SCLC) who received this combination reported encouraging safety and effectiveness results.
The treatment demonstrated good safety outcomes, with most side effects being manageable. For example, some patients experienced common side effects like tiredness or nausea, but these were usually mild or moderate.
Both sacituzumab govitecan and the immunotherapies atezolizumab and durvalumab have already received FDA approval for treating other types of cancer, indicating a recognized level of safety. However, participants should discuss their personal risks and benefits with their healthcare provider.12345Why are researchers excited about this trial's treatments?
Researchers are excited about sacituzumab govitecan combined with immunotherapy because it offers a unique approach to treating lung cancer. Unlike standard treatments like chemotherapy and radiation, sacituzumab govitecan is an antibody-drug conjugate that delivers chemotherapy directly to cancer cells, potentially reducing side effects. Additionally, when paired with immunotherapies like atezolizumab or durvalumab, this combination aims to enhance the immune system's ability to fight cancer. This dual-action strategy could improve outcomes for patients who may not respond well to conventional treatments.
What evidence suggests that this trial's treatments could be effective for lung cancer?
This trial will evaluate the combination of sacituzumab govitecan (SG) with immunotherapy drugs, either atezolizumab or durvalumab, for treating extensive-stage small cell lung cancer. Research has shown that combining SG with immunotherapy drugs like atezolizumab or durvalumab may help treat this condition. In one study, about 42% of patients experienced tumor shrinkage with this combination. Additionally, patients lived an average of 4.4 months without their cancer worsening, known as progression-free survival (PFS). The average time patients lived after starting treatment, called overall survival (OS), was 13.6 months. These results suggest that this treatment could help control tumor growth for some patients.12346
Are You a Good Fit for This Trial?
Adults with extensive stage small cell lung cancer who've had 4-6 cycles of chemo/immunotherapy without disease progression. They must be able to consent, have an ECOG status of 0-2, no uncontrolled HIV/HBV/HCV, stable brain metastasis, and adequate organ function. Those with active infections or unstable brain metastasis can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sacituzumab govitecan and atezolizumab/durvalumab every 21 days for up to 2 years or until disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with radiographic imaging continuing during long-term follow-up.
Long-term follow-up
Survival status is assessed every 12 weeks until the participant dies, withdraws consent, or the study is terminated.
What Are the Treatments Tested in This Trial?
Interventions
- Atezolizumab
- Durvalumab
- Sacituzumab govitecan
Trial Overview
The trial tests if sacituzumab govitecan (SG) combined with atezolizumab/durvalumab controls tumor growth in lung cancer patients. Treatment is every 21 days for up to two years, monitored by CT scans and MRI.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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)
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Who Is Running the Clinical Trial?
Bindu R Potugari
Lead Sponsor
Gilead Sciences
Industry Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
Citations
Study Details | NCT07339059 | SG and Immunotherapy as ...
Among 43 patients enrolled, the overall response rate was 41.9%, with a median PFS of 4.4 months (95% CI 3.81-6.11) and a median OS of 13.6 ...
Sacituzumab govitecan: another emerging treatment option for ...
Among 43 patients, the overall response rate (ORR) assessed by investigators was 41.9% [95% confidence interval (CI): 27.0–57.9%], including 18 ...
How Will ADCs Influence the Treatment Landscape in ...
To begin, Leal reviewed results from the phase 3 ADRIATIC trial (NCT03703297), which had a median progression-free survival (PFS) of 16.6 months ...
Phase 2 Open-Label Study of Sacituzumab Govitecan as ...
The results from this phase 2 study indicate that patients with ES-SCLC benefit from SG treatment, with an ORR of 41.9% and a median DOR of 4.73 ...
SG + Immunotherapy for Lung Cancer · Info for Participants
The trial tests if sacituzumab govitecan (SG) combined with atezolizumab/durvalumab controls tumor growth in lung cancer patients. Treatment is ...
6.
conference-correspondent.com
conference-correspondent.com/highlights/esmo/esmo-2023/tropics-03-basket-trial-results-of-second-line-sacituzumab-govitecan-for-extensive-stage-sclcTROPiCS-03 Basket Trial Results of Second-Line ...
Sacituzumab govitecan (SG) is a Trop-2–directed antibody-drug conjugate that has demonstrated antitumor activity in previously treated ES-SCLC in a phase 1/2 ...
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