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Alkylating agents

Immunotherapy + Chemotherapy for Lung Cancer (POSEIDON Trial)

Phase 3

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically documented Stage IV NSCLC

No prior exposure to immunemediated therapy, excluding therapeutic anticancer vaccines

Must not have

Active or prior documented autoimmune or inflammatory disorders

Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing two different ways to treat lung cancer that has spread, one with two immunotherapy drugs and one with just one immunotherapy drug, compared to just using chemotherapy drugs.

Who is the study for?

This trial is for adults with Stage IV non-small cell lung cancer (NSCLC) without certain gene mutations. Participants should be in good physical condition, not have had previous systemic therapy for metastatic NSCLC, and must not have autoimmune diseases, mixed lung cancers, brain metastases unless stable and off steroids, or active infections like TB or hepatitis.

What is being tested?

The study compares three treatments: Durvalumab plus Tremelimumab with standard chemotherapy, Durvalumab with standard chemotherapy alone versus just the standard chemo. It's a Phase III trial to see which combination works best as a first line treatment for advanced lung cancer without specific genetic changes.

What are the potential side effects?

Durvalumab and Tremelimumab can cause immune-related side effects such as inflammation of organs; they may also lead to infusion reactions. Standard chemotherapies can cause nausea, hair loss, fatigue and increase infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer is confirmed to be at stage IV.

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I have never received immune therapy, except for cancer vaccines.

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My tumor's PD-L1 status has been confirmed.

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My cancer does not have EGFR mutations or ALK fusions.

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I am fully active or can carry out light work.

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I have not received any treatment for my advanced lung cancer.

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I am 18 years old or older.

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 active infections like TB, hepatitis B, hepatitis C, or HIV.

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My lung cancer is a mix of small-cell and non-small cell types.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS); D + SoC Compared With SoC Alone

Progression-Free Survival (PFS); D + SoC Compared With SoC Alone

Secondary study objectives

Best Objective Response (BoR)

Duration of Response (DoR)

Number of Patients With ADA Response to Tremelimumab

+9 more

Other study objectives

The safety and tolerability profile of durvalumab +/- tremelimumab in combination with standard of care chemotherapy as determined by adverse events (AEs), physical examninations, laboratory data and vital signs