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Clinical Trials List

Protocol NumberD419MC00004
NCT Number(ClinicalTrials.gov Identfier)NCT03164616
Active

2017-05-01 - 2020-07-31

Phase III

Recruiting1

Terminated9

ICD-10C34

Malignant neoplasm of bronchus and lung

A Phase III, Randomized, Multi-Center, Open-Label, Comparative Global Study to Determine the Efficacy of Durvalumab or Durvalumab and Tremelimumab in Combination With Platinum-Based Chemotherapy for First-Line Treatment in Patients With Metastatic Non Small-Cell Lung Cancer (NSCLC) (POSEIDON)

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Yung-Hung Luo Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

9 Recruiting

Audit

CRO

Principal Investigator 魏裕峰 Division of Thoracic Medicine
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Te-Chun Hsia Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chien-Chung Lin Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator kang-Yun LEE Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 李建德 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Non Small-Cell Lung Cancer (NSCLC)

Objectives

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.

Test Drug

Durvalumab / Tremelimumab

Active Ingredient

Humanized anti-CTLA-4 mAb
Humanized anti-PD-1 mAb

Dosage Form

injection

Dosage

50

Endpoints

Primary Outcome Measures :
Progression-free survival (PFS) using Blinded Independent Central Review (BICR) assessments according to RECIST 1.1 [ Time Frame: Up to 3 years after first patient randomized ]
Overall Survival (OS) [ Time Frame: Up to 4 years after first patient randomized ]

Secondary Outcome Measures :
Progression-free survival (PFS) using BICR assessments according to RECIST 1.1 [ Time Frame: Up to 3 years after first patient randomized ]
Overall survival (OS) [ Time Frame: Up to 4 years after first patient randomized ]
Objective response rate (ORR) using BICR assessments according to RECIST 1.1 [ Time Frame: Up to 3 years after first patient randomized ]
Duration of response (DoR) using BICR assessments according to RECIST 1.1 [ Time Frame: Up to 3 years after first patient randomized ]
Time from randomization to second progression (PFS2) [ Time Frame: Up to 3 years after first patient randomized ]
Proportion of patients alive and progression free at 12 months from randomization (APF12) using BICR assessments according to RECIST 1.1 [ Time Frame: Up to 12 months ]
Best objective response (BoR) using BICR assessments according to RECIST 1.1 [ Time Frame: Up to 3 years after first patient randomized ]
The pharmacokinetics (PK) of durvalumab and tremelimumab as determined by concentration [ Time Frame: Up to 3 years after first patient randomized ]
The immunogenicity of durvalumab and tremelimumab as assessed by presence of anti-drug antibodies (ADAs) [ Time Frame: Up to 3 years after first patient randomized ]
Health-related QoL measured by EORTC QLQ-C30 v3 [ Time Frame: Up to 3 years after first patient randomized ]
Disease-related symptoms measured by EORTC QLQ-LC13 [ Time Frame: Up to 3 years after first patient randomized ]
Changes in WHO/ECOG performance status [ Time Frame: Up to 3 years after first patient randomized ]

Inclution Criteria

Inclusion criteria
For inclusion in the study, patients should fulfill the following criteria:
1. Age ≥18 years at the time of screening. In Japan, patients must be ≥20 years at the
time of screening.
2. Written informed consent and any locally required authorization (eg, Health
Insurance Portability and Accountability Act in the US, European Union [EU] Data
Privacy Directive in the EU) obtained from the patient/legal representative prior to
performing any protocol-related procedures, including screening evaluations.
3. Histologically or cytologically documented Stage IV NSCLC not amenable to
curative surgery or radiation (according to Version 8 of the IASLC Staging Manual
in Thoracic Oncology; IASLC Staging Manual in Thoracic Oncology).
4. Patients must have tumors that lack activating EGFR mutations
(eg, exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or
exon 20 S768I mutation) and ALK fusions. If a patient has squamous histology or
is known to have a tumor with a KRAS mutation, then EGFR and ALK testing is
not required.
5. No prior chemotherapy or any other systemic therapy for metastatic NSCLC.
Patients who have received prior platinum-containing adjuvant, neoadjuvant, or
definitive chemoradiation for advanced disease are eligible, provided that
progression has occurred >12 months from end of last therapy (see exclusion
criterion 7).
6. Tumor PD-L1 status, confirmed by a reference laboratory using the Ventana SP263
PD-L1 immunohistochemistry (IHC) assay, must be known prior to randomization.
As such, all patients must be able to undergo a fresh tumor biopsy during screening
or to provide an available tumor sample taken <3 months prior to enrollment.
Tumor lesions used for newly acquired biopsies should not be the same lesions used
as RECIST target lesions, unless there are no other lesions suitable for biopsy; and
in this instance only core needle (not excisional/incisional) biopsy is allowed. For
patients with a single target lesion, if screening biopsy is collected prior to
screening imaging for baseline tumor assessment, allow approximately 2 weeks
before imaging scans are acquired. Samples with limited tumor content and fine needle aspirate specimens are not acceptable. Specimens from metastatic bone
lesions are typically unacceptable unless there is a significant soft tissue component.
The tumor specimen submitted to establish eligibility should be of sufficient
quantity to allow for PD-L1 IHC and other exploratory biomarker analyses and is
preferred in formalin-fixed paraffin-embedded blocks.
7. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG)
performance status of 0 or 1 at enrollment and randomization.
8. Body weight >30 kg
9. At least 1 lesion, not previously irradiated, that can be accurately measured at
baseline as ≥10 mm in the longest diameter (except lymph nodes which must have a
short axis ≥15 mm) with CT or MRI and that is suitable for accurate repeated
measurements as per RECIST 1.1 guidelines.
10. No prior exposure to immune-mediated therapy including, but not limited to, other
anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding
therapeutic anticancer vaccines.
11. Adequate organ and marrow function as defined below:
 Hemoglobin ≥9.0 g/dL
 Absolute neutrophil count ≥1.5 × 109
/L
 Platelet count ≥100 × 109
/L
 Total bilirubin 0.3 to 1.9 mg/dL × ULN, based on local site’s normal range.
This will not apply to patients with confirmed Gilbert’s syndrome, who will be
allowed in consultation with their physician
 ALT and AST ≤2.5 × ULN; for patients with hepatic metastases, ALT and
AST ≤5 × ULN
 Calculated creatinine clearance (CL) ≥40 mL/min as determined by
Cockcroft-Gault (using actual body weight) or 24-hour urine collection
12. Evidence of post-menopausal status or negative urinary or serum pregnancy test for
female premenopausal patients. Women will be considered post-menopausal if they
have been amenorrheic for 12 months without an alternative medical cause. The
following age-specific requirements apply:
 Women <50 years of age would be considered post-menopausal if they have
been amenorrheic for 12 months or more following cessation of exogenous
hormonal treatments and if they have luteinizing hormone and folliclestimulating hormone levels in the post-menopausal range for the institution or
underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
 Women ≥50 years of age would be considered post-menopausal if they have
been amenorrheic for 12 months or more following cessation of all exogenous
hormonal treatments, had radiation-induced oophorectomy with last menses
>1 year ago, had chemotherapy-induced menopause with last menses >1 year
ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral
salpingectomy, or hysterectomy).

Exclusion Criteria

Exclusion criteria
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
1. Involvement in the planning and/or conduct of the study (applies to both
AstraZeneca staff and/or staff at the study site).
2. Previous IP assignment in the present study.
3. Concurrent enrollment in another clinical study, unless it is an observational
(non-interventional) clinical study or the follow-up period of an interventional study.
4. Participation in another clinical study with an IP during the last 12 months.
5. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.
6. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer
treatment. Concurrent use of hormonal therapy for non-cancer-related conditions
(eg, hormone replacement therapy) is acceptable.
7. No radiation therapy is allowed, unless it is 1) definitive radiation that had been
administered at least 12 months prior, 2) palliative radiation to brain, with
associated criteria for stability or lack of symptoms (see also exclusion criterion 15),
or 3) palliative radiation to painful bony lesions (this must comprise less than 30%
of the bone marrow).
8. Major surgical procedure (as defined by the Investigator) within 28 days prior to the
first dose of the IP. Note: Local surgery of isolated lesions for palliative intent is
acceptable.
9. History of allogenic organ transplantation.
10. Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the
exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome,
or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease,
rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to
this criterion:
 Patients with vitiligo or alopecia
 Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on
hormone replacement or psoriasis not requiring systemic treatment
 Any chronic skin condition that does not require systemic therapy
 Patients without active disease in the last 5 years may be included but only
after consultation with the study physician
 Patients with celiac disease controlled by diet alone
11. Uncontrolled intercurrent illness, including but not limited to, ongoing or active
infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable
angina pectoris, cardiac arrhythmia, ILD, serious chronic gastrointestinal conditions
associated with diarrhea, or psychiatric illness/social situations that would limit
compliance with study requirement, that substantially increase risk of incurring AEs
or compromise the ability of the patient to give written informed consent.
12. Medical contraindication to platinum-based doublet chemotherapy
13. History of another primary malignancy except for
 Malignancy treated with curative intent and with no known active disease
≥5 years before the first dose of the IP and of low potential risk for recurrence
 Adequately treated nonmelanoma skin cancer or lentigo maligna without
evidence of disease
 Adequately treated carcinoma in situ without evidence of disease (eg, cervical
cancer in situ)
14. History of leptomeningeal carcinomatosis.
15. Brain metastases or spinal cord compression unless the patient’s condition is stable
(asymptomatic; no evidence of new or emerging brain metastases) and off steroids
for at least 14 days prior to the start of the IP. Following radiotherapy and/or
surgery, patients with brain metastases must wait 4 weeks after the intervention and
must confirm stable condition using imaging before randomization. Patients with
suspected brain metastases at screening should have an intravenous (IV) contrastenhanced MRI (preferred) or IV contrast-enhanced CT of the brain prior to study
entry. Brain metastases will not be recorded as RECIST Target Lesions at baseline.
16. History of active primary immunodeficiency.
17. Active infection including tuberculosis (clinical evaluation that includes clinical
history, physical examination and radiographic findings, and TB testing in line
with local practice), hepatitis B (known positive HBV surface antigen (HBsAg)
result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2
antibodies). Patients with a past or resolved HBV infection (defined as the presence
of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are
eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if
polymerase chain reaction is negative for HCV RNA.
18. Current or prior use of immunosuppressive medication within 14 days before the
first dose of durvalumab or tremelimumab. The following are exceptions to this
criterion:
 Intra-nasal, inhaled, topical steroids, or local steroid injections
(eg, intra-articular injection)
 Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of
prednisone or its equivalent
 Steroids as premedication for hypersensitivity reactions (eg, CT scan
premedication, cytotoxic chemotherapy premedication)
19. Receipt of live, attenuated vaccine within 30 days prior to the first dose of the IP.
Note: Patients, if enrolled, should not receive live vaccine during the study and up
to 30 days after the last dose of the IP.
20. Female patients who are pregnant or breastfeeding or male or female patients of
reproductive potential who are not willing to employ effective birth control from
screening to 90 days after the last dose of durvalumab monotherapy or 180 days
after the last dose of durvalumab + tremelimumab combination therapy.
21. Known allergy or hypersensitivity to any of the study drugs or any of the study drug
excipients.
22. Prior randomization or treatment in a previous durvalumab and/or tremelimumab
clinical study regardless of treatment arm assignment.
23. Judgment by the Investigator that the patient is unsuitable to participate in the study
and the patient is unlikely to comply with study procedures, restrictions, and
requirements.

The Estimated Number of Participants

  • Taiwan

    100 participants

  • Global

    1000 participants

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