160 Participants Needed

Chemotherapy + Nivolumab for Small Cell Lung Cancer

Recruiting at 900 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Cancer Institute (NCI)
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

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot be on other investigational agents or certain immunosuppressive medications, and you must not have received a live vaccine within 4 weeks before joining the trial.

What data supports the effectiveness of the drug combination of chemotherapy and Nivolumab for small cell lung cancer?

Research shows that combinations of platinum drugs like cisplatin or carboplatin with etoposide are standard treatments for small cell lung cancer, leading to median survival times of 7 to 20 months depending on the stage. These combinations have been shown to be effective, although they can have significant side effects.12345

Is the combination of chemotherapy drugs and Nivolumab safe for treating small cell lung cancer?

The combination of carboplatin and etoposide is generally well-tolerated in small cell lung cancer, with fewer side effects compared to cisplatin and etoposide. Common side effects include blood-related issues like low white blood cell counts, but serious complications are rare.36789

How is the drug combination of chemotherapy and Nivolumab unique for small cell lung cancer?

This treatment combines standard chemotherapy drugs like carboplatin, cisplatin, and etoposide with Nivolumab, an immunotherapy drug that helps the immune system attack cancer cells, offering a novel approach by potentially enhancing the body's immune response against small cell lung cancer.12101112

What is the purpose of this trial?

This trial is testing whether adding nivolumab to standard chemotherapy improves treatment for patients with extensive stage small cell lung cancer. The chemotherapy drugs kill or stop the growth of cancer cells, while nivolumab helps the immune system attack the cancer. Nivolumab is an immunotherapy drug that has shown promise in treating various cancers, including non-small cell lung cancer and melanoma.

Research Team

TA

Ticiana A Leal

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for adults with extensive stage small cell lung cancer who haven't had prior treatment. They must have normal organ and marrow function, no severe allergies to monoclonal antibodies or study drugs, and not be on other investigational agents. Women of childbearing age and sexually active men must use contraception.

Inclusion Criteria

I do not have autoimmune diseases or conditions needing steroids or immunosuppressants.
I do not have lung disease causing symptoms or severe allergies to the study drug.
Patients may not be receiving any other investigational agents while on study
See 11 more

Exclusion Criteria

You have a positive test for hepatitis B virus or hepatitis C virus, meaning you have an active or long-lasting infection.
I have not received a live vaccine in the last 4 weeks.
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive cisplatin/carboplatin and etoposide with or without nivolumab. Treatment repeats every 21 days for up to 4 cycles.

12 weeks
4 cycles, each with multiple visits for drug administration

Maintenance

Patients in Arm A continue to receive nivolumab every 2 weeks for up to 2 years.

up to 2 years
Bi-weekly visits for nivolumab administration

Follow-up

Participants are monitored for safety and effectiveness after treatment. Follow-up every 3 months if less than 2 years from registration, every 6 months for years 2-3, and yearly up to 5 years.

up to 5 years
Regular follow-up visits as per schedule

Treatment Details

Interventions

  • Carboplatin
  • Cisplatin
  • Etoposide
  • Nivolumab
Trial Overview The trial tests if adding Nivolumab (an immunotherapy drug) to standard chemotherapy (Cisplatin/Carboplatin and Etoposide) improves outcomes in patients with extensive stage small cell lung cancer compared to chemotherapy alone.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (nivolumab, CE)Experimental Treatment4 Interventions
Patients receive nivolumab IV over 30 minutes on day 1, carboplatin IV over 30-60 minutes on day 1 or cisplatin IV over 60-120 minutes on day 1, and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients continue to receive nivolumab IV over 30 minutes every 2 weeks for up to 2 years.
Group II: Arm B (CE)Active Control3 Interventions
Patients receive carboplatin IV over 30-60 minutes on day 1 or cisplatin IV over 60-120 minutes on day 1, and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

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?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+

Findings from Research

A systematic review of 36 clinical trials found that chemotherapy regimens including cisplatin (CDDP) and/or etoposide (VP16) significantly improve survival rates in patients with small cell lung cancer (SCLC), with combined hazard ratios indicating a clear survival benefit for both drugs.
Specifically, regimens containing etoposide alone or in combination with cisplatin showed strong evidence of effectiveness, with hazard ratios of 0.72 for VP16 and 0.57 for combinations, suggesting these treatments should be prioritized in SCLC therapy.
A systematic review of the role of etoposide and cisplatin in the chemotherapy of small cell lung cancer with methodology assessment and meta-analysis.Mascaux, C., Paesmans, M., Berghmans, T., et al.[2019]
Combination treatments using platinum compounds and etoposide show median survival rates of 7 to 10 months for extensive-stage and 15 to 20 months for limited-stage small cell lung cancer, indicating their effectiveness in improving patient outcomes.
Adding paclitaxel to platinum/etoposide regimens has shown promising results in early studies, with good activity and manageable toxicity, and ongoing phase III trials aim to clarify its role in enhancing treatment efficacy.
The current role and future prospects of paclitaxel in the treatment of small cell lung cancer.Hainsworth, JD., Greco, FA.[2015]
In a trial involving 228 patients with advanced non-small-cell lung cancer, cisplatin (CDDP) combined with etoposide showed a higher objective response rate (27%) compared to carboplatin (CBDCA) with etoposide (16%), although this difference was not statistically significant (P = .07).
Cisplatin treatment was associated with significantly increased toxicity, particularly myelosuppression and renal function impairment, indicating that while it may be more effective, it also poses greater risks compared to carboplatin.
A randomized study comparing cisplatin or carboplatin with etoposide in patients with advanced non-small-cell lung cancer: European Organization for Research and Treatment of Cancer Protocol 07861.Klastersky, J., Sculier, JP., Lacroix, H., et al.[2017]

References

A systematic review of the role of etoposide and cisplatin in the chemotherapy of small cell lung cancer with methodology assessment and meta-analysis. [2019]
The current role and future prospects of paclitaxel in the treatment of small cell lung cancer. [2015]
A randomized study comparing cisplatin or carboplatin with etoposide in patients with advanced non-small-cell lung cancer: European Organization for Research and Treatment of Cancer Protocol 07861. [2017]
Randomized phase II trial of pemetrexed combined with either cisplatin or carboplatin in untreated extensive-stage small-cell lung cancer. [2015]
Phase III study of pemetrexed plus carboplatin compared with etoposide plus carboplatin in chemotherapy-naive patients with extensive-stage small-cell lung cancer. [2015]
Carboplatin/etoposide in small cell lung cancer. [2018]
Paclitaxel, carboplatin, and oral etoposide: a phase II trial in limited-stage small cell lung cancer. [2015]
Clinical status of carboplatin. [2013]
Multi-center study of two dose levels of paclitaxel with carboplatin in locally advanced and metastatic non-small cell lung cancer (NSCLC). [2015]
10.United Statespubmed.ncbi.nlm.nih.gov
Basis for experimental chemotherapy in lung cancer. [2018]
Superiority of cisplatin or carboplatin in combination with teniposide and vincristine in the induction chemotherapy of small-cell lung cancer. A randomized trial with 5 years follow up. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Etoposide (VP-16) and cisplatin: an effective treatment for relapse in small-cell lung cancer. [2017]
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