Durvalumab for Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new approach for treating small cell lung cancer (SCLC) that surgery has completely removed. Researchers aim to determine if combining Durvalumab (an immunotherapy) with chemotherapy can help prevent cancer recurrence. The trial targets individuals who have undergone surgery to remove their SCLC and have not yet received other treatments. Participants should have recovered from surgery and not have other major health issues. This study seeks to offer new hope by potentially enhancing the effectiveness of post-surgery treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to advancements in SCLC care.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that durvalumab, when combined with chemotherapy, is promisingly safe for treating small cell lung cancer (SCLC). One study found that patients receiving durvalumab with chemotherapy lived longer than those receiving only chemotherapy, indicating the treatment is generally well-tolerated.
Another study demonstrated that patients with limited-stage SCLC who took durvalumab lived longer than those who took a placebo, further supporting its safety. The FDA has approved durvalumab for certain stages of SCLC, confirming it meets safety standards for these uses.
While side effects can occur with any treatment, evidence so far suggests that durvalumab is generally safe and well-tolerated for small cell lung cancer.12345Why are researchers excited about this trial's treatments for small cell lung cancer?
Durvalumab is unique because it targets the PD-L1 protein on cancer cells, which helps the immune system recognize and attack the cancer more effectively. Unlike the standard treatments for small cell lung cancer, which typically involve chemotherapy drugs like cisplatin or carboplatin combined with etoposide, durvalumab offers a novel approach by enhancing the body's own immune response. Researchers are excited about this treatment because it could potentially improve survival rates and provide a more targeted therapy with possibly fewer side effects compared to traditional chemotherapy.
What evidence suggests that this trial's treatments could be effective for small cell lung cancer?
Research has shown that durvalumab can significantly improve survival rates for people with small cell lung cancer (SCLC). In studies, patients who received durvalumab after chemoradiotherapy lived longer and experienced more time before their cancer worsened compared to those who received a placebo. Specifically, patients lived an average of 55.9 months with durvalumab, compared to 33.4 months with a placebo. Additionally, real-world data confirm that durvalumab helps patients with extensive-stage small cell lung cancer live longer. In this trial, participants will receive durvalumab in combination with one of two chemotherapy regimens: cisplatin or carboplatin, and etoposide. These findings suggest that durvalumab could be a promising treatment option for SCLC.46789
Who Is on the Research Team?
Chi-Fu Jeffrey Yang, MD
Principal Investigator
Massachusetts General Hospital
Jacob Sands, MD
Principal Investigator
Dana-Farber Cancer Institute
Evanthia Galanis, MD
Principal Investigator
Alliance Foundation Trials, LLC.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive adjuvant chemotherapy and immunotherapy with durvalumab for completely resected small cell lung cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for overall survival and long-term safety
What Are the Treatments Tested in This Trial?
Interventions
- Durvalumab
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
65 participants will be enrolled.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alliance Foundation Trials, LLC.
Lead Sponsor
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Citations
Durvalumab in Limited-Stage Small Cell Lung Cancer
Despite high initial response rates, most patients relapse, and long-term survival remains poor, with approximately 30%-35% alive at 5 years.
Durvalumab after Chemoradiotherapy in Limited-Stage ...
Adjuvant therapy with durvalumab led to significantly longer overall survival and progression-free survival than placebo among patients with limited-stage ...
ES-SCLC Clinical Trial Results for IMFINZI® (durvalumab)
Learn how IMFINZI® (durvalumab) was studied in people diagnosed with extensive stage-small cell lung cancer (ES-SCLC) and view the clinical trial results.
4.
oncology-central.com
oncology-central.com/durvalumab-extends-survival-in-sclc-but-cost-effectiveness-questioned/Durvalumab extends survival in SCLC but cost ...
Findings from the ADRIATIC trial have shown that durvalumab significantly improves survival for patients with limited-stage small cell lung ...
Durvalumab real-world treatment patterns and outcomes in ...
Estimated 1- and 2-year OS rates were 83.5 and 64.0%, respectively, with median OS not reached. Conclusion: This study confirmed an OS benefit ...
Efficacy and safety of durvalumab + chemotherapy vs ... - PMC
Durvalumab and atezolizumab have recently been approved in extensive small cell lung cancer (SCLC) with moderate median overall survival (OS)
Multi-omic analysis and overall survival update of phase II ...
The median PFS was 6.77 months (95% CI, 5.75-8.97), median overall survival was 14.59 months (95% CI 12.98–22.34). The 1-2-3 survival rate was ...
Durvalumab Plus Platinum-Etoposide in Extensive-Stage ...
Previously reported findings from the phase 3 CASPIAN study demonstrated a clear survival benefit with durvalumab plus EP versus EP alone in patients with ES- ...
Real-world comparison of the efficacy and safety ...
Dr. Bruna Pellini presents key data comparing real-world outcomes of atezolizumab versus durvalumab in extensive-stage small cell lung cancer (ES-SCLC).
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.