49 Participants Needed

Durvalumab + Radiation for Small Cell Lung Cancer

Recruiting at 1 trial location
CM
AJ
CC
Overseen ByCancer Clinical Trials Office
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This this study is for individuals who have treatment-naïve extensive-stage small cell lung cancer (small cell lung cancer that wont respond to treatment). Doctors leading this study hope to learn if combining durvalumab, carboplatin and etoposide with hyofractionated ablative radiation therapy (radiation focused on certain parts of the body) will help treat your cancer and improve how long you can live with extensive-stage small cell cancer without it getting worse (progression-free survival). Your participation in this research will last about 48 months. Durvalumab along with chemotherapy has been approved by the Food and Drug Administration (FDA) for the treatment of small cell lung cancer along with chemotherapy. This study is testing the addition of radiation to durvalumab and chemotherapy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot take other cancer treatments or immunosuppressive medications within 14 days before starting the trial.

What data supports the effectiveness of the treatment Durvalumab + Radiation for Small Cell Lung Cancer?

Research shows that adding durvalumab to chemotherapy (carboplatin and etoposide) significantly improves overall survival in patients with extensive-stage small-cell lung cancer compared to chemotherapy alone. This suggests that durvalumab is an effective addition to treatment for this type of lung cancer.12345

Is the combination of Durvalumab and chemotherapy safe for treating lung cancer?

Durvalumab, when used with chemotherapy drugs like etoposide and carboplatin or cisplatin, has been shown to have a manageable safety profile in patients with extensive-stage small cell lung cancer, meaning it is generally considered safe for use in humans.12367

What makes the drug combination of Durvalumab, Carboplatin, and Etoposide unique for treating small cell lung cancer?

This treatment is unique because it combines Durvalumab, an immune therapy that helps the body's immune system fight cancer, with chemotherapy drugs Carboplatin and Etoposide, and has shown to improve survival in patients with extensive-stage small cell lung cancer compared to chemotherapy alone.138910

Research Team

Christine Bestvina, MD - UChicago Medicine

Christine M. Bestvina

Principal Investigator

University of Chicago - Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults over 18 with newly diagnosed extensive-stage small cell lung cancer that hasn't been treated yet. Participants must have a life expectancy of at least 12 weeks, be able to perform daily activities (ECOG status 0-2), and have tumors suitable for focused radiation. They should not be pregnant or breastfeeding, agree to use contraception, and cannot have had previous treatments like chemotherapy or certain immunotherapies for lung cancer.

Inclusion Criteria

I weigh more than 30 kilograms.
I am eligible for platinum-based chemotherapy as my first treatment for extensive small cell lung cancer.
You are expected to live for at least 12 more weeks.
See 11 more

Exclusion Criteria

I am not pregnant or breastfeeding and willing to use birth control during and up to 90 days after treatment.
You have had an organ transplant from someone else.
Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to four 21-day cycles of chemotherapy with carboplatin, etoposide, and durvalumab, with ablative radiation added during the second cycle

12 weeks

Maintenance

Participants continue to receive a fixed dose of durvalumab until disease progression, serious side effects, or withdrawal from the study

Up to 48 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

  • Ablative Radiation
  • Carboplatin
  • Durvalumab
  • Etoposide
Trial OverviewThe study tests if adding ablative radiation therapy to the FDA-approved combination of durvalumab (an immunotherapy drug), carboplatin, and etoposide can improve survival without cancer progression in patients with extensive-stage small cell lung cancer. The treatment's effectiveness will be monitored over approximately four years.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Participants With Extensive Small Cell Lung Cancer (All Participants)Experimental Treatment4 Interventions
This arm will involve all participants in the study who have extensive small cell lung cancer that has not responded to previous treatments. All participants will receive the same treatment of study drugs and radiation treatment in "cycles" (a specific window of time). You will receive up to four 21-day cycles of chemotherapy using carboplatin, etoposide and durvalumab (immunotherapy) as part of a standard care treatment plan recommended by your doctor. These drugs will be combined with ablative radiation treatment during the second cycle of chemotherapy. After completing these four cycles of chemotherapy (with radiation treatment added in cycle 2), you will continue to receive a fixed dose of durvalumab until your cancer progresses, you experience serious side effects, you decide to no longer be part of the study or the study doctor request to take you off the study for medical reasons.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Paraplatin for:
  • Ovarian cancer
  • Testicular cancer
  • Lung cancer
  • Head and neck cancer
  • Brain cancer
🇪🇺
Approved in European Union as Carboplatin for:
  • Ovarian cancer
  • Small cell lung cancer
🇨🇦
Approved in Canada as Carboplatin for:
  • Ovarian cancer
  • Small cell lung cancer
  • Testicular cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials
1,086
Recruited
844,000+

Findings from Research

In the phase III CASPIAN study, the combination of durvalumab with etoposide and either cisplatin or carboplatin significantly improved overall survival in patients with extensive-stage small-cell lung cancer compared to etoposide plus platinum alone.
Patient-reported outcomes showed that the addition of durvalumab not only maintained quality of life but also delayed the worsening of key symptoms like appetite loss, cough, and fatigue, indicating a beneficial impact on patients' overall well-being.
Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase III study.Goldman, JW., Garassino, MC., Chen, Y., et al.[2021]
In the CASPIAN study involving 805 patients with extensive-stage small-cell lung cancer (ES-SCLC), the combination of durvalumab and platinum-etoposide significantly improved overall survival compared to platinum-etoposide alone, with a median survival of 12.9 months versus 10.5 months.
However, adding tremelimumab to durvalumab and platinum-etoposide did not provide a significant survival benefit, indicating that durvalumab plus platinum-etoposide should be considered the new standard of care for first-line treatment of ES-SCLC.
Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial.Goldman, JW., Dvorkin, M., Chen, Y., et al.[2021]
In the phase III CASPIAN trial involving previously untreated adults with extensive-stage small cell lung cancer (ES-SCLC), the addition of durvalumab to chemotherapy significantly improved overall survival and progression-free survival compared to chemotherapy alone.
Durvalumab combined with etoposide and either carboplatin or cisplatin demonstrated a manageable safety profile, making it a valuable first-line treatment option and an accepted standard of care for patients with ES-SCLC.
Durvalumab: A Review in Extensive-Stage SCLC.Al-Salama, ZT.[2022]

References

Patient-reported outcomes with first-line durvalumab plus platinum-etoposide versus platinum-etoposide in extensive-stage small-cell lung cancer (CASPIAN): a randomized, controlled, open-label, phase III study. [2021]
Durvalumab, with or without tremelimumab, plus platinum-etoposide versus platinum-etoposide alone in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): updated results from a randomised, controlled, open-label, phase 3 trial. [2021]
Durvalumab: A Review in Extensive-Stage SCLC. [2022]
A phase II study of carboplatin and etoposide plus durvalumab for previously untreated extensive-stage small-cell lung cancer (ES-SCLC) patients with a poor performance status (PS): NEJ045A study protocol. [2022]
Durvalumab, with or without tremelimumab, plus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer: 3-year overall survival update from CASPIAN. [2022]
Durvalumab after definitive chemoradiotherapy in locally advanced unresectable non-small cell lung cancer (NSCLC): Real-world data on survival and safety from the German expanded-access program (EAP). [2021]
Durvalumab after definitive chemoradiotherapy in locally advanced NSCLC: Data of the German EAP. [2020]
Durvalumab Plus Concurrent Radiotherapy for Treatment of Locally Advanced Non-Small Cell Lung Cancer: The DOLPHIN Phase 2 Nonrandomized Controlled Trial. [2023]
DUART: durvalumab after radiotherapy in patients with unresectable, stage III NSCLC who are ineligible for chemotherapy. [2022]
Durvalumab in non-small-cell lung cancer patients: current developments. [2018]