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Platinum-based Chemotherapy

Chemotherapy + Nivolumab for Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Ticiana A Leal
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No patients with specific autoimmune diseases, neuromuscular paraneoplastic syndromes, or conditions requiring systemic treatment with corticosteroids or immunosuppressive medications
No patients with symptomatic interstitial lung disease or severe hypersensitivity reaction to study drug components
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months
Awards & highlights

Study Summary

This trial is testing whether adding nivolumab to cisplatin/carboplatin and etoposide will improve outcomes for patients with extensive stage small cell lung cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include allergic reactions, immune system-related issues affecting organs, fatigue, nausea, low blood counts increasing infection risk. Nivolumab may also cause skin problems or hormonal gland changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have autoimmune diseases or conditions needing steroids or immunosuppressants.
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I do not have lung disease causing symptoms or severe allergies to the study drug.
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My blood tests and liver/kidney function are within required ranges.
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I have no severe allergies to monoclonal antibodies or the study drug's components.
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I have extensive stage small cell lung cancer and can undergo systemic therapy.
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I have not received chemotherapy or biologic therapy for my extensive stage small cell lung cancer.
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I haven't received drugs targeting my immune system to treat cancer.
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I do not have lung disease that causes symptoms or could affect lung toxicity tests.
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I am fully active or can carry out light work.
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I have been cancer-free for at least 2 years if I had another cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks for 6 months, then every 8 weeks until 1 year, and then every 12 weeks until being off treatment or end of observation. thereafter every 3 months if < 2 years from registration, every 6 months for years 2-3, and yearly up to 3 years 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free Survival (PFS)
Secondary outcome measures
Overall Survival (OS)
Response Rate
Other outcome measures
Association Between Circulating Tumor DNA and Clinical Outcome
PD-L1 Expression Level

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Cisplatin
2013
Completed Phase 3
~1940
Etoposide
2010
Completed Phase 3
~2440
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,993 Total Patients Enrolled
Ticiana A LealPrincipal InvestigatorECOG-ACRIN Cancer Research Group
1 Previous Clinical Trials
27 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03382561 — Phase 2
Small Cell Lung Cancer Research Study Groups: Arm B (CE), Arm A (nivolumab, CE)
Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03382561 — Phase 2
Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03382561 — Phase 2
Small Cell Lung Cancer Patient Testimony for trial: Trial Name: NCT03382561 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other instances of Cisplatin research exist?

"City of Hope Comprehensive Cancer Center was the first to trial cisplatin in 1997 and, since then, 2186 completed studies have followed. Currently, 2045 research centres are actively recruiting patients for clinical trials – a significant portion of which are based in Antioch, California."

Answered by AI

What is the government's official stance on Cisplatin?

"Cisplatin has received a score of 2 from our team at Power. This is due to the fact that it is still in Phase 2 clinical trials meaning that while there some data supporting its safety, there is none yet affirming its efficacy."

Answered by AI

When is Cisplatin most commonly given to patients?

"Cisplatin can be used as an effective treatment against metastatic hepatocellular carcinoma, lymphoma, non-hodgkin, and malignant melanoma of skin."

Answered by AI

Can patients sign up to participate in this research right now?

"According to the information available on clinicaltrials.gov, this study is no longer recruiting patients. This particular trial was first posted on May 2nd 2018 and had its most recent update on September 23rd 2022. Even though this specific study has completed recruitment, there are 4,829 other studies that still need participants."

Answered by AI

Is this clinical trial active in many hospitals across North America?

"Patients are currently being recruited from over 100 hospitals and medical centres, including Kaiser Permanente-Deer Valley Medical Center in Antioch, California; University of Chicago Comprehensive Cancer Center in Chicago, Illinois; and Cancer Care and Hematology-Fort Collins in Fort Collins, Colorado."

Answered by AI

How many people are allowed to sign up for this experiment?

"Unfortunately, this particular study is not currently looking for any more volunteers. However, there are 2784 other trials related to carcinoma and 2045 studies investigating Cisplatin that are actively recruiting patients right now."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Ohio
Florida
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
What site did they apply to?
The Watson Clinic
Billings Clinic Cancer Center
Cleveland Clinic Mercy Hospital

Why did patients apply to this trial?

I want to be on some kind of treatment. Instead of doing nothing.
PatientReceived no prior treatments
Recent research and studies
Clinical TherapeuticsJournal
Meta-analysis of the Efficacy and Tolerability of Immune Checkpoint Inhibitors Combined with Chemotherapy in First-line Treatment of Small Cell Lung Cancer
Wu, Jiao, Aifen Zhang, Lu Li, Sicheng Liu, Fang Yang, and Runxiang Yang. 2021. “Meta-analysis of the Efficacy and Tolerability of Immune Checkpoint Inhibitors Combined with Chemotherapy in First-line Treatment of Small Cell Lung Cancer”. Clinical Therapeutics. Elsevier BV. doi:10.1016/j.clinthera.2020.12.017.
clinicaltrials.govStudy
Cisplatin/Carboplatin and Etoposide With or Without Nivolumab in Treating Patients With Extensive Stage Small Cell Lung Cancer
2018. "Cisplatin/Carboplatin and Etoposide With or Without Nivolumab in Treating Patients With Extensive Stage Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03382561.
All > Small Cell Lung Cancer
~23 spots leftby Apr 2025
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