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Checkpoint Inhibitor

single agent immune checkpoint blockade (ICB) + chemotherapy (CT) for Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Led By Aakash Desai, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 24 months

Awards & highlights

Study Summary

"This trial, called DISCERN, is comparing two treatments for a type of lung cancer that doesn't have a specific marker. They want to see if using two immune therapies along with chemotherapy is more

Who is the study for?

The DISCERN trial is for individuals with a type of lung cancer called NSCLC that lacks the PD-L1 marker. Participants should be suitable for chemotherapy but have not been treated with immune therapy before.Check my eligibility

What is being tested?

This study compares two treatments: one combines two types of immune therapy (Ipilimumab and Nivolumab) with chemo, while the other uses just one immune therapy (Pembrolizumab) plus chemo. It monitors changes in cancer DNA in blood after treatment begins.See study design

What are the potential side effects?

Possible side effects include allergic reactions to drugs, fatigue, nausea, potential damage to organs from immune therapies, and typical chemotherapy-related issues like hair loss and lowered immunity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 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

Rate of Molecular Response in Patients with PD-L1 Negative Advanced NSCLC Treated with Dual vs. Single ICB Plus CT Regimens

Secondary outcome measures

Correlation Analysis

Efficacy Evaluation

Other outcome measures

Median Overall Survival (OS)

Progression-Free Survival (PFS)

Tolerability Assessment

Trial Design

2Treatment groups

Experimental Treatment

Group I: single agent immune checkpoint blockade (ICB) + chemotherapy (CT)Experimental Treatment4 Interventions

200 mg of Pembrolizumab will be administered intravenously (IV) every 3 weeks (Q3W) for 4 cycles. Combination chemotherapy: For squamous NSCLC: Carboplatin (dose according to area under the curve (AUC) 6) + paclitaxel 200 mg/m². For non-squamous NSCLC: Carboplatin (AUC 5) + pemetrexed 500 mg/m². Maintenance Therapy for Non-Squamous NSCLC: Pembrolizumab 200 mg + pemetrexed 500 mg/m² Q3W for up to 2 years.

Group II: dual agent immune checkpoint blockade (ICB) + chemotherapy (CT)Experimental Treatment5 Interventions

Drug 1: 360 mg of Nivolumab will be administered intravenously (IV) every 3 weeks (Q3W). Drug 2: 1 mg/kg of Ipilimumab will be administered intravenously (IV) every 6 weeks (Q6W) for 2 cycles. Combination Chemotherapy: For squamous NSCLC: Carboplatin (AUC 6) + paclitaxel 200 mg/m². For non-squamous NSCLC: Carboplatin (AUC 5) + pemetrexed 500 mg/m². Maintenance Therapy for Non-Squamous NSCLC: Nivolumab 360 mg Q3W + Ipilimumab 1mg/kg Q6W for up to 2 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Nivolumab

2014

Completed Phase 3

~4750

Ipilimumab

2014

Completed Phase 3

~2620

Pemetrexed

2014

Completed Phase 3

~5250

Paclitaxel

2011

Completed Phase 4

~5380

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,591 Previous Clinical Trials

2,281,641 Total Patients Enrolled

Aakash Desai, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Frequently Asked Questions

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

What is the risk level associated with utilizing single agent immune checkpoint blockade (ICB) in conjunction with chemotherapy (CT) for patients?

"According to our assessment at Power, the safety level of combining single agent immune checkpoint blockade (ICB) with chemotherapy (CT) is rated as 2 on a scale from 1 to 3. This evaluation reflects that while there are indications supporting its safety in this Phase 2 trial, data confirming efficacy is currently lacking."

Answered by AI

Is the ongoing medical study actively seeking participants at this time?

"The current status on clinicaltrials.gov shows that recruitment for this particular trial is not active. The initial posting date was October 31, 2024, with the latest update made on April 10, 2024. Despite this trial being inactive in terms of participant recruitment, there are currently 2090 other trials actively seeking candidates."

Answered by AI

Is there an inclusion of individuals under the age of 30 in this research study?

"Eligible candidates for this research study must be between 19 and 89 years old. Notably, there are a total of 43 trials catering to individuals below the age of 18, and an impressive count of 2080 trials dedicated to those above 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC

Aakash Desai, MD 2024. "DISCERN: Dual Versus Single ICB in PDL-1 Negative NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06364917.