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Platinum-based Chemotherapy

Chemotherapy + Nivolumab for Early Stage Non-Small Cell Lung Cancer

Phase 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
No brain metastasis
Must not have
Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy for NSCLC
Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up to approximately 44 months
Awards & highlights
Pivotal Trial

Summary

This trial is testing if using immunotherapy before and after surgery can prolong event-free survival for people with early stage non-small cell lung cancer.

Who is the study for?
This trial is for adults with early stage Non-Small Cell Lung Cancer that can be surgically removed. They should not have had previous cancer treatments, no brain metastasis, and must be in good physical condition (ECOG ≤ 1). Patients who've received certain immunotherapies or have autoimmune diseases, hepatitis B/C, or HIV cannot participate.
What is being tested?
The study tests if adding the drug Nivolumab to standard chemotherapy before and after surgery can extend the time patients remain free from cancer events compared to just chemotherapy with a placebo. Participants are randomly assigned to receive either Nivolumab or placebo.
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation of organs like lungs or intestines, skin rash, hormone gland problems (like thyroid), liver issues, and fatigue. Chemotherapy drugs used may also cause hair loss, nausea, low blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My cancer has not spread to my brain.
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My lung cancer is at an early stage and can be surgically removed.
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I can provide a sample of my tumor for testing.
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I have not received any systemic anti-cancer treatments for my NSCLC.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received cancer treatments such as chemotherapy, immunotherapy, targeted therapy, or radiation for NSCLC.
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I have previously received treatments targeting the immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to approximately 44 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up to approximately 44 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event-Free Survival (EFS) by BICR
Secondary study objectives
Major Pathological Response (MPR) Rate
Overall Survival (OS)
Pathologic Complete Response (pCR) Rate
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. NivoExperimental Treatment6 Interventions
Group II: Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac.Placebo Group6 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~6550
Paclitaxel
2011
Completed Phase 4
~5450
Pemetrexed
2014
Completed Phase 3
~5550
Nivolumab
2015
Completed Phase 3
~4010
Cisplatin
2013
Completed Phase 3
~3120
Carboplatin
2014
Completed Phase 3
~6120

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,683 Previous Clinical Trials
4,129,094 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04025879 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Neoadj. Plac. + Pt-based Doublet Chemo followed by Adj.Plac., Neoadj. Nivo+ Pt-based Doublet Chemo followed by Adj. Nivo
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04025879 — Phase 3
Carboplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04025879 — Phase 3
~77 spots leftby Nov 2025
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