Overview

Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).

Status:
Recruiting
Trial end date:
2024-08-29
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Albumin-Bound Paclitaxel
Antibodies, Monoclonal
Carboplatin
Cisplatin
Durvalumab
Gemcitabine
Pemetrexed
Tremelimumab
Criteria
Inclusion Criteria:

For inclusion in the study, patients should fulfill the following criteria:

1. Aged at least 18 years.

2. Histologically or cytologically documented Stage IV NSCLC.

3. Confirmed tumor PD-L1 status prior to randomization.

4. Patients must have tumors that lack activating EGFR mutations and ALK fusions.

5. No prior chemotherapy or any other systemic therapy for metastatic NSCLC.

6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance
status of 0 or 1.

7. No prior exposure to immunemediated therapy, excluding therapeutic anticancer
vaccines.

Exclusion Criteria:

Patients should not enter the study if any of the following exclusion criteria are
fulfilled:

1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.

2. Active or prior documented autoimmune or inflammatory disorders.

3. Brain metastases or spinal cord compression unless the patient's condition is stable
and off steroids.

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