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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
Must not have
Active or prior documented autoimmune or inflammatory disorders
Symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening until the follow-up period is completed [approx. up to 48 months]
Awards & highlights

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had an autoimmune or inflammatory disorder.
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I do not have uncontrolled heart problems or symptoms like chest pain or irregular heartbeat.
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I have lasting side effects from cancer treatment, but not hair loss or skin color changes.
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My lung cancer is a mix of small cell and non-small cell types.
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I have not received a live vaccine in the last 30 days.
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I am currently pregnant, breastfeeding, or planning to become pregnant.
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I haven't had major surgery in the last 28 days and don't expect to need any during the study.
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I have had cancer spread to the lining of my brain and spinal cord.
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My spinal cord compression is not causing symptoms and is stable.
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My HIV infection is not well controlled.
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I cannot receive platinum-based chemotherapy due to health reasons.
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I am not currently on any cancer treatments like chemotherapy or hormone therapy.
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I have not undergone radiation therapy, or I meet specific criteria for it.
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I do not have any uncontrolled diseases or a history of organ transplant from another person.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
OS in subset of randomized participants with STK11 or KEAP1 mutations and/or co-mutations
Overall survival (OS)
Secondary study objectives
Duration of response (DOR)
Number of participants with adverse events (AEs) and serious adverse events (SAEs).
Objective response rate (ORR)
+9 more

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
Pembrolizumab
2017
Completed Phase 3
~2850
Pemetrexed
2014
Completed Phase 3
~5550
Carboplatin
2014
Completed Phase 3
~6120
Cisplatin
2013
Completed Phase 3
~3120
Durvalumab
2017
Completed Phase 2
~3780
Tremelimumab
2017
Completed Phase 2
~3070

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,370 Previous Clinical Trials
288,737,415 Total Patients Enrolled
~187 spots leftby Aug 2027