Immunotherapy + Chemotherapy for Lung Cancer

(POSEIDON Trial)

Recruiting at 144 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy + Standard of care (SoC) chemotherapy or durvalumab monotherapy + SoC chemotherapy versus SoC chemotherapy alone as first line treatment in patients with metastatic non small-cell lung cancer (NSCLC) with tumors that lack activating epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) fusions.

Research Team

Xiaojin Shi, M.D., MSc

Principal Investigator

One MedImmune Way, Gaithersburg, Maryland 20878, United States

Eligibility Criteria

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.

Inclusion Criteria

My lung cancer is confirmed to be at stage IV.

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

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

Exclusion Criteria

My brain or spinal cord cancer is stable without needing steroids.

I have or had an autoimmune or inflammatory disorder.

I do not have active infections like TB, hepatitis B, hepatitis C, or HIV.

Treatment Details

Interventions

• Abraxane + carboplatin (Alkylating agents)
• Durvalumab (Checkpoint Inhibitor)
• Gemcitabine + carboplatin (Anti-metabolites)
• Gemcitabine + cisplatin (Anti-metabolites)
• Pemetrexed + carboplatin (Anti-metabolites)
• Pemetrexed + cisplatin (Anti-metabolites)
• Tremelimumab (Checkpoint Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Treatment Arm 2 Experimental Treatment 6 Interventions

durvalumab monotherapy + SoC chemotherapy

Group II: Treatment Arm 1 Experimental Treatment 7 Interventions

durvalumab + tremelimumab combination therapy + SoC chemotherapy

Group III: Treatment Arm 3 Active Control 5 Interventions

SoC chemotherapy alone

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology