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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

No Placebo-Only Group

Pivotal 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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening until the follow-up period is completed [approx. up to 48 months]

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

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

~3150

Pemetrexed

2014

Completed Phase 3

~5550