544 Participants Needed

Atezolizumab + Chemoradiation for Small Cell Lung Cancer

Recruiting at 577 trial locations
RA
SG
Overseen ByStephen G. Chun
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: National Cancer Institute (NCI)
Must be taking: Platinum/etoposide chemotherapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

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, if you are on systemic corticosteroids or other immunosuppressive medications, you may need to stop them 14 days before starting the study treatment.

What data supports the effectiveness of the drug Atezolizumab combined with chemotherapy for small cell lung cancer?

Research shows that adding Atezolizumab to chemotherapy with carboplatin and etoposide significantly improved survival in patients with extensive-stage small cell lung cancer, without negatively affecting their quality of life.12345

Is the combination of atezolizumab, chemotherapy, and radiation therapy generally safe for humans?

Research shows that the combination of atezolizumab with chemotherapy (carboplatin and etoposide) and radiation therapy has been studied for safety in patients with small cell lung cancer and other conditions. In a study, patients experienced some severe blood-related side effects, but these were managed by adjusting medication doses, and no severe non-blood-related side effects were reported. Overall, this combination has been considered safe for use in humans, with careful monitoring and dose adjustments as needed.678910

What makes the treatment with Atezolizumab and Chemoradiation unique for small cell lung cancer?

This treatment combines atezolizumab, an immune checkpoint inhibitor, with chemotherapy and advanced radiation techniques like 3D-CRT and IMRT, offering a novel approach that enhances survival outcomes for extensive-stage small cell lung cancer compared to chemotherapy alone.56111213

What is the purpose of this trial?

This phase III trial studies how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving chemoradiation with or without atezolizumab may work better in treating patients with limited stage small cell lung cancer.

Research Team

KA

Kristin A Higgins

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for adults with a confirmed diagnosis of limited stage small cell lung cancer. Participants must have had one cycle of specific chemotherapy, be in good physical condition (ECOG 0-2), and have proper organ function. Pregnant women, those with certain medical conditions or previous treatments like immunotherapy, and individuals not using contraception are excluded.

Inclusion Criteria

Your liver function tests showed AST and ALT levels within a certain range before the start of the study.
Your total bilirubin level was not higher than 1.5 times the normal limit before starting the study.
My kidney function, measured by creatinine clearance, is adequate.
See 15 more

Exclusion Criteria

I've had radiation to my chest area that overlaps with new treatment areas.
You have fluid around your lungs or heart that has tested positive for abnormal cells.
I have an active hepatitis B or C infection.
See 18 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiation

Patients receive etoposide and cisplatin or carboplatin with radiation therapy. Cycles repeat every 21 days for 3 cycles.

9 weeks
Multiple visits for chemotherapy and radiation sessions

Immunotherapy

Patients receive atezolizumab IV on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles.

1 year
17 visits for immunotherapy administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Every 3 months for 2 years, then every 6 months for 3 years, then annually

Treatment Details

Interventions

  • 3-Dimensional Conformal Radiation Therapy
  • Atezolizumab
  • Carboplatin
  • Cisplatin
  • Etoposide
  • Intensity-Modulated Radiation Therapy
Trial Overview The study is examining the effectiveness of adding Atezolizumab to standard chemoradiation therapy for treating small cell lung cancer. It compares outcomes between patients receiving usual treatment alone versus those also getting this new immunotherapy drug.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (chemotherapy, radiation therapy, atezolizumab)Experimental Treatment9 Interventions
Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
Group II: Arm I (chemotherapy, radiation therapy)Active Control8 Interventions
Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.

3-Dimensional Conformal Radiation Therapy is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

🇺🇸
Approved in United States as 3D-CRT for:
  • Various types of cancer, including gynecologic cancers
🇪🇺
Approved in European Union as 3D-CRT for:
  • Various types of cancer, including gynecologic cancers
🇨🇦
Approved in Canada as 3D-CRT for:
  • Various types of cancer, including gynecologic cancers
🇯🇵
Approved in Japan as 3D-CRT for:
  • Various types of cancer, including gynecologic cancers
🇨🇳
Approved in China as 3D-CRT for:
  • Various types of cancer, including gynecologic cancers
🇨🇭
Approved in Switzerland as 3D-CRT for:
  • Various types of cancer, including gynecologic cancers

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

NRG Oncology

Collaborator

Trials
242
Recruited
105,000+

Findings from Research

In a study of 90 patients with limited stage small cell lung cancer, concurrent radiotherapy combined with carboplatin and etoposide significantly improved median survival time to 26 months compared to 19 months for those receiving sequential treatment.
The 5-year survival rate was also better in the concurrent treatment group at 27%, versus 16% in the sequential group, indicating that concurrent treatment may be a more effective approach for this type of cancer.
[Concurrent radiotherapy combined with carboplatin and etoposide in limited stage small cell lung cancer].Qiao, TK., Zhou, DA., Xin, L., et al.[2016]
In a study of 47 patients with limited disease small-cell lung carcinoma, the combination of carboplatin and etoposide followed by thoracic radiotherapy resulted in a 73% overall response rate, but the median survival time was only 13.7 months, indicating limited long-term efficacy.
The treatment was associated with significant adverse effects, including grade 3-4 neutropenia in 46% of patients and febrile neutropenia in 14%, highlighting safety concerns despite the initial response to therapy.
Carboplatin and etoposide followed by once-daily thoracic radiotherapy in limited disease small-cell lung cancer: unsatisfactory results.Yilmaz, U., Anar, C., Korkmaz, E., et al.[2022]
In a study of 108 patients with extensive-stage small-cell lung cancer, the combination of irinotecan + cisplatin (IP) sequential chemotherapy with radiotherapy showed significantly better efficacy compared to etoposide + cisplatin (EP) chemotherapy, resulting in higher overall survival (16.2 months vs. 12.7 months) and progression-free survival (8.4 months vs. 5.9 months).
The EP+IP group also demonstrated a significant reduction in serum tumor markers and circulating tumor cells, indicating a more effective treatment response and potentially fewer blood-related side effects compared to the EP group.
Efficacy of EP Chemotherapy Followed by IP Chemotherapy Combined with Radiotherapy in the Treatment of Extensive-Stage Small-Cell Lung Cancer.Kang, S., Lai, CORXWZJHYZDCJ.[2021]

References

[Concurrent radiotherapy combined with carboplatin and etoposide in limited stage small cell lung cancer]. [2016]
Carboplatin and etoposide followed by once-daily thoracic radiotherapy in limited disease small-cell lung cancer: unsatisfactory results. [2022]
A randomized phase II trial of irinotecan plus carboplatin versus etoposide plus carboplatin treatment in patients with extended disease small-cell lung cancer. [2020]
Efficacy of EP Chemotherapy Followed by IP Chemotherapy Combined with Radiotherapy in the Treatment of Extensive-Stage Small-Cell Lung Cancer. [2021]
Atezolizumab: A Review in Extensive-Stage SCLC. [2021]
Chemotherapy plus atezolizumab for a patient with small cell lung cancer undergoing haemodialysis: a case report and review of literature. [2021]
Efficacy and Safety of Bladder Preservation Therapy in Combination with Atezolizumab and Radiation Therapy (BPT-ART) for Invasive Bladder Cancer: Interim Analysis from a Multicenter, Open-label, Prospective Phase 2 Trial. [2023]
Safety and patient-reported outcomes of atezolizumab, carboplatin, and etoposide in extensive-stage small-cell lung cancer (IMpower133): a randomized phase I/III trial. [2022]
Protocol of the TREASURE study: Thoracic RadiothErapy with Atezolizumab in Small cell lUng canceR Extensive disease - a randomized, open-label, multicenter phase II trial. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Phase I Trial of Pembrolizumab and Radiation Therapy after Induction Chemotherapy for Extensive-Stage Small Cell Lung Cancer. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
SKYSCRAPER-02: Tiragolumab in Combination With Atezolizumab Plus Chemotherapy in Untreated Extensive-Stage Small-Cell Lung Cancer. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
A 75-Year-Old Female Smoker with Advanced Small-Cell Lung Cancer and Eastern Cooperative Oncology Group Performance Status 2 who Responded to Combination Immunochemotherapy with Atezolizumab, Etoposide, and Carboplatin. [2022]
Atezolizumab addition to platinum doublet: evaluating survival outcomes for patients with extensive disease small cell lung cancer. [2023]
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