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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years from randomization

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years from randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years from randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years from randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event-Free Survival (EFS) as Assessed by Blinded Independent Central Review (BICR)

Secondary outcome measures

Incidence of Adverse Events (AEs)

Incidence of Serious Adverse Events (SAEs)

Major Pathological Response (MPR) Rate as Assessed by Blinded Independent Pathology Review

+2 more

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

~5620

Paclitaxel

2011

Completed Phase 4

~5380

Pemetrexed

2014

Completed Phase 3

~5250

Nivolumab

2014

Completed Phase 3

~4750

Cisplatin

2013

Completed Phase 3

~1940

Carboplatin

2014

Completed Phase 3

~6670

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,128,032 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

Frequently Asked Questions

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

In how many different places is this experiment being done today?

"This clinical trial has 19 active sites, which are enrolling patients. These locations include Augusta University in Augusta, Georgia, Northside Hospital in Atlanta, Illinois, and Northwestern University in Chicago, Pennsylvania."

Answered by AI

Has Nivolumab received government approval for medical use?

"Nivolumab has been studied in multiple Phase 3 trials, meaning there is some data supporting efficacy and multiple rounds of data supporting safety. Our team at Power estimates the safety of Nivolumab to be a 3 on a scale from 1 to 3."

Answered by AI

How large is the sample size for this research project?

"In order to run this clinical trial, 452 patients that fit the pre-determined inclusion criteria are needed. The patients can travel to multiple locations, such as Augusta University in Augusta, Georgia and Northside Hospital in Atlanta, Illinois, in order to participate."

Answered by AI

For what purpose is Nivolumab most commonly prescribed?

"Nivolumab is an effective treatment for neoplasm metastasis, metastatic ureter urothelial carcinoma, and metastatic hepatocellular carcinoma."

Answered by AI

Are there other similar tests that have been done using Nivolumab?

"Nivolumab was first studied in 1997 and, as of now, there have been 21274 completed trials. There are 2463 active studies recruiting patients with many of these centred in Augusta, Georgia."

Answered by AI

Are we currently enrolling people for this research project?

"That is correct. The aforementioned website has this trial listed as currently looking for 452 individuals to participate. These 16 sites have been collecting data since November 5th, 2019."

Answered by AI

Recent research and studies

Cancer ResearchJournal

Neoadjuvant Intratumoral Immunotherapy with TLR9 Activation and Anti-ox40 Antibody Eradicates Metastatic Cancer

Hong, Wan Xing, Idit Sagiv-Barfi, Debra K. Czerwinski, Adrienne Sallets, and Ronald Levy. 2022. “Neoadjuvant Intratumoral Immunotherapy with TLR9 Activation and Anti-ox40 Antibody Eradicates Metastatic Cancer”. Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/0008-5472.can-21-1382.

Cell Reports MedicineJournal

Neoadjuvant Therapy Gains FDA Approval in Non-small Cell Lung Cancer

Leal, Ticiana A., and Suresh S. Ramalingam. 2022. “Neoadjuvant Therapy Gains FDA Approval in Non-small Cell Lung Cancer”. Cell Reports Medicine. Elsevier BV. doi:10.1016/j.xcrm.2022.100691.

clinicaltrials.govStudy

A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

2019. "A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04025879.

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