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Chemotherapy

Durvalumab + Tremelimumab + Chemo vs Pembrolizumab + Chemo for Lung Cancer (TRITON Trial)

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have tumors with STK11 or KEAP1 or KRAS mutations. Co-mutations are also allowed
Body weight of > 30 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening until the follow-up period is completed [approx. up to 48 months]
Awards & highlights

TRITON Trial Summary

This trial tests if two drugs plus chemo work better than one drug plus chemo to treat metastatic lung cancer with gene mutations.

Who is the study for?
This trial is for adults with Stage IV non-squamous NSCLC who haven't had systemic therapy for metastatic disease. They must have specific mutations (STK11, KEAP1, or KRAS), good organ function, and no history of certain cancers or immune disorders. Participants need a life expectancy over 12 weeks, be able to use contraception, and not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study compares the effectiveness of two treatments: Durvalumab plus Tremelimumab with chemotherapy versus Pembrolizumab with chemotherapy in patients whose tumors have specific genetic changes. The goal is to see which combination works better for this type of lung cancer.See study design
What are the potential side effects?
Possible side effects include immune-related reactions affecting organs, infusion-related symptoms like fever or chills, fatigue, nausea, blood cell count changes increasing infection risk. Each patient may experience side effects differently.

TRITON Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor has STK11, KEAP1, or KRAS mutations.
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My body weight is more than 30 kg.
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My cancer does not have certain genetic changes in EGFR or ALK.
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I have a tumor that can be measured and has not been treated with radiation.
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My advanced lung cancer cannot be cured with surgery or radiation.
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I am fully active or restricted in physically strenuous activity but can do light work.

TRITON Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening until the follow-up period is completed [approx. up to 48 months]
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening until the follow-up period is completed [approx. up to 48 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
OS in subset of randomized participants with STK11 or KEAP1 mutations and/or co-mutations
Overall survival (OS)
Secondary outcome measures
Duration of response (DOR)
Number of participants with adverse events (AEs) and serious adverse events (SAEs).
Objective response rate (ORR)
+9 more

TRITON Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: Pembrolizumab + Platinum-based ChemotherapyExperimental Treatment4 Interventions
Participants will receive pembrolizumab regimen q3w for four 21-day cycles in combination with chemotherapy followed by maintenance therapy (pembrolizumab plus pemetrexed maintenance) q3w until disease progression or unacceptable toxicity for up to 24 months or treatment discontinuation.
Group II: Arm A: Durvalumab + Tremelimumab + Platinum-based ChemotherapyExperimental Treatment5 Interventions
Participants will receive durvalumab plus tremelimumab q3w for four 21-day cycles in combination with chemotherapy followed by maintenance therapy (durvalumab plus pemetrexed maintenance) every 4 weeks (q4w) until disease progression or unacceptable toxicity or treatment discontinuation. During the maintenance therapy phase, participants will receive an additional cycle of durvalumab plus tremelimumab (plus pemetrexed, where applicable) at Week 16.
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
Pemetrexed
2014
Completed Phase 3
~5250
Durvalumab
2017
Completed Phase 2
~3870
Tremelimumab
2017
Completed Phase 2
~3380
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,612,423 Total Patients Enrolled

Frequently Asked Questions

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

What milestones is this research endeavor attempting to reach?

"This clinical trial will primarily evaluate Overall Survival (OS) across a subset of participants with STK11 or KEAP1 mutations and/or co-mutations over the 48 month duration. Secondary objectives include Progression-Free Survival, Time to First Subsequent Treatment, and Number of Patients Experiencing Adverse Events/Serious Adverse Events as safety measurements between durvalumab plus tremelimumab plus chemotherapy and pembrolizumab plus chemotherapy for non-squamous histology in metastatic NSCLC patients with specified gene alterations."

Answered by AI

In how many geographical areas is this research project taking place?

"The current trial is being conducted in 20 different sites, which includes Fort Lauderdale, Atlanta and Columbus. To limit the associated travelling costs when participating, it would be advantageous to choose the closest site possible."

Answered by AI

Is the combination of Durvalumab, Tremelimumab and Platinum-based Chemotherapy a viable therapeutic option for individuals?

"Arm A: Durvalumab + Tremelimumab + Platinum-based Chemotherapy is deemed safe enough to merit a score of 3 due to its progress in clinical trials and the amount of data that supports efficacy."

Answered by AI

Am I eligible to enroll in this trial?

"This medical trial is currently accepting 280 participants with non-small cell lung cancer, aged between 18 and 130."

Answered by AI

Can individuals over 40 years old participate in this research study?

"This clinical research requires participants to be between 18 and 130 years old. Notably, there are 43 studies that offer the medication to those under eighteen while 1968 trials can cater for individuals over sixty-five."

Answered by AI

Are there still available openings for this research endeavor?

"The clinicaltrials.gov database shows that this particular trial, which was posted on November 29th 2023 and last modified on the 7th of same month, is no longer recruiting patients. Nevertheless, 1975 other studies are currently welcoming participants."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients
2024. "A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic Non-Small Cell Lung Cancer (NSCLC) Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06008093.
All > Non Small Cell Lung Cancer
~187 spots leftby Aug 2027
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