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

Primary Purpose

Non Small Cell Lung Cancer NSCLC

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Durvalumab

Tremelimumab

Abraxane + carboplatin

Gemcitabine + cisplatin

Gemcitabine + carboplatin

Pemetrexed + carboplatin

Pemetrexed + cisplatin

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer NSCLC focused on measuring NSCLC, Programmed cell death ligand 1 (PD-L1), Durvalumab, Tremelimumab, Progression-free survival (PFS), Overall survival (OS)

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Aged at least 18 years.
Histologically or cytologically documented Stage IV NSCLC.
Confirmed tumor PD-L1 status prior to randomization.
Patients must have tumors that lack activating EGFR mutations and ALK fusions.
No prior chemotherapy or any other systemic therapy for metastatic NSCLC.
World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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:

Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant.
Active or prior documented autoimmune or inflammatory disorders.
Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids.
Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Arm 1

Treatment Arm 2

Treatment Arm 3

Arm Description

durvalumab + tremelimumab combination therapy + SoC chemotherapy

durvalumab monotherapy + SoC chemotherapy

SoC chemotherapy alone

Outcomes

Primary Outcome Measures

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

PFS (per RECIST version 1.1 [RECIST 1.1] using Blinded Independent Central Review [BICR] assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique. The final analysis of PFS in the global cohort was pre-specified after approximately 497 BICR PFS events occurred across the D + SoC and SoC alone treatment arms (75% maturity).

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

OS was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The final analysis of OS in the global cohort was pre-specified after approximately 532 OS events occurred across the D + SoC and SoC alone treatment arms (80% maturity).

Secondary Outcome Measures

PFS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC

PFS (per RECIST 1.1 using BICR assessments) was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Median PFS was calculated using the Kaplan-Meier technique.

OS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC

Objective Response Rate (ORR)

ORR (per RECIST 1.1 using BICR assessments) was defined as the percentage of patients with at least one visit response of complete response (CR) or partial response (PR). Results are presented for the pre-specified ORR analysis using unconfirmed responses based on BICR.

Best Objective Response (BoR)

The BoR was calculated based on the overall visit responses from each RECIST 1.1 assessment. BOR was defined as the best response a patient had following randomization, but prior to starting any subsequent cancer therapy and up to and including RECIST 1.1 progression or the last evaluable assessment in the absence of RECIST 1.1 progression, as determined by BICR. Categorization of BoR was based on RECIST using the following 'response' categories: CR and PR and the following 'non-response' categories: stable disease (SD) ≥6 weeks, progression (ie, PD) and not evaluable (NE). Results are presented for number (%) of patients in each specified category.

Duration of Response (DoR)

DoR (per RECIST 1.1 using BICR assessments) was defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression. The end of response coincided with the date of progression or death from any cause used for the RECIST 1.1 PFS endpoint. The time of the initial response was defined as the latest of the dates contributing towards the first visit of PR or CR. Results are presented for the pre-specified DoR analysis using unconfirmed responses based on BICR.

Time From Randomization to Second Progression (PFS2)

PFS2 was defined as the time from the date of randomization to the earliest of the progression event (subsequent to that used for the primary variable PFS) or death. The date of second progression was recorded by the Investigator and defined according to local standard clinical practice and could involve any of: objective radiological imaging, symptomatic progression or death.

Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations

To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.

PK of Tremelimumab; Peak and Trough Serum Concentrations

To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of tremelimumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.

Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab

Blood samples were collected at pre-specified timepoints and number of patients who developed detectable ADAs against durvalumab was determined. ADA prevalence is defined as percentage of patients with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as either treatment-induced ADA or treatment-boosted ADA. ADA incidence is percentage of patients who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted by ≥4-fold during the study period. Persistently positive is defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks (112 days) between the first and last positive, or an ADA positive result at the last available assessment. Transiently positive is defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of neutralizing antibody (nAb) was tested for all ADA positive samples.

Number of Patients With ADA Response to Tremelimumab

Blood samples were collected at pre-specified timepoints and number of patients who developed detectable ADAs against tremelimumab was determined. ADA prevalence is defined as percentage of patients with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as either treatment-induced ADA or treatment-boosted ADA. ADA incidence is percentage of patients who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted by ≥4-fold during the study period. Persistently positive is defined as having ≥2 post-baseline ADA positive measurements with ≥16 weeks (112 days) between the first and last positive, or an ADA positive result at the last available assessment. Transiently positive is defined as having ≥1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Presence of nAb was tested for all ADA positive samples.

Time to Deterioration of Global Health Status / Health-Related Quality of Life (HRQoL) and Patient Reported Outcome (PRO) Symptoms, Assessed Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)

The EORTC QLQ-Core 30 version 3 (QLQ-C30 v3) was included for assessing HRQoL. It assesses HRQoL/health status through 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and a global health and QoL scale. 6 single-item symptom measures are also included: dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores from 0 to 100 were derived for each of the 15 domains, with higher scores representing greater functioning, greater HRQoL, or greater level of symptoms. Time to deterioration was defined as time from randomization until the date of first clinically meaningful deterioration that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.

Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-Lung Cancer Module 13 (QLQ-LC13)

The EORTC QLQ-LC13 is a disease-specific 13-item self-administered questionnaire for lung cancer, to be used in conjunction with the EORTC QLQ-C30. It comprises both multi-item and single-item measures of lung cancer-associated symptoms (ie, coughing, hemoptysis, dyspnea, and pain) and treatment-related symptoms from conventional chemotherapy and radiotherapy (ie, hair loss, neuropathy, sore mouth, and dysphagia). Scores from 0 to 100 were derived for each symptom item, with higher scores representing greater level of symptoms. Time to deterioration was defined as time from randomization until the date of first clinically meaningful deterioration that was confirmed at a subsequent visit or death (by any cause) in the absence of a clinically meaningful deterioration.

Full Information

NCT ID

NCT03164616

First Posted

May 22, 2017

Last Updated

September 7, 2023

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT03164616

Brief Title

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

Acronym

POSEIDON

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

March 12, 2021 (Actual)

Study Completion Date

May 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed Description

Adult patients with a histologically or cytologically documented metastatic NSCLC, with tumors that lack activating EGFR mutations and ALK fusions, are eligible for enrollment. Patients will be randomized in a 1:1:1 ratio to receive treatment with durvalumab + tremelimumab combination therapy + SoC chemotherapy, durvalumab monotherapy + SoC chemotherapy, or SoC chemotherapy alone. Tumor evaluation scans will be performed until objective disease progression as efficacy assessment. All patients will be followed for survival until the end of the study. An independent data monitoring committee (IDMC) composed of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer NSCLC

Keywords

NSCLC, Programmed cell death ligand 1 (PD-L1), Durvalumab, Tremelimumab, Progression-free survival (PFS), Overall survival (OS)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1186 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Arm 1

Arm Type

Experimental

Arm Description

durvalumab + tremelimumab combination therapy + SoC chemotherapy

Arm Title

Treatment Arm 2

Arm Type

Experimental

Arm Description

durvalumab monotherapy + SoC chemotherapy

Arm Title

Treatment Arm 3

Arm Type

Active Comparator

Arm Description

SoC chemotherapy alone

Intervention Type

Drug

Intervention Name(s)

Durvalumab

Intervention Description

IV infusions every 3 weeks for 12 weeks (4 cycles) and every 4 weeks thereafter until disease progression or other discontinuation criteria

Intervention Type

Drug

Intervention Name(s)

Tremelimumab

Intervention Description

IV infusions every 3 weeks for 12 weeks (4 cycles). An additional dose of tremelimumab will be administered in the week 16.

Intervention Type

Drug

Intervention Name(s)

Abraxane + carboplatin

Intervention Description

Standard of care chemotherapy (squamous and non-squamous patients): Abraxane 100 mg/m2 on Days 1, 8, and 15 of each 21-day cycle. Carboplatin Area under the plasma drug concentration-time curve (AUC) 5 or 6 via IV infusion on Day 1 of each 21-day cycle for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3).

Intervention Type

Drug

Intervention Name(s)

Gemcitabine + cisplatin

Intervention Description

Standard of care chemotherapy (squamous patients only): Gemcitabine 1000 or 1250 mg/m2 via IV infusion on Days 1 and 8 of each 21-day cycle + cisplatin 75 mg/m2 via IV infusion on Day 1 of each 21-day cycle, for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3).

Intervention Type

Drug

Intervention Name(s)

Gemcitabine + carboplatin

Intervention Description

Standard of care chemotherapy (squamous patients only): Gemcitabine 1000 or 1250 mg/m2 via IV infusion on Days 1 and 8 of each 21-day cycle + carboplatin AUC 5 or 6 via IV infusion on Day 1 of each 21-day cycle for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3).

Intervention Type

Drug

Intervention Name(s)

Pemetrexed + carboplatin

Intervention Description

Standard of care chemotherapy (non-squamous patients only): Pemetrexed 500 mg/m2 and carboplatin AUC 5 or 6 via IV infusion on Day 1 of each 21-day cycle for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3); then continue pemetrexed 500 mg/m2 maintenance [i.e., q4w for Treatment Arms 1 and 2. For Treatment Arm 3, Pemetrexed maintenance therapy can be given either q3w or q4w (dependent on Investigator decision and local standards)] until objective disease progression.

Intervention Type

Drug

Intervention Name(s)

Pemetrexed + cisplatin

Intervention Description

Standard of care chemotherapy (non-squamous patients only): Pemetrexed 500 mg/m2 and cisplatin 75 mg/m2 via IV infusion on Day 1 of each 21-day cycle, for 4 to 6 cycles (ie, 4 cycles for Treatment Arms 1 and 2 and 4 to 6 cycles for Treatment Arm 3); then continue pemetrexed 500 mg/m2 maintenance [i.e., q4w for Treatment Arms 1 and 2. For Treatment Arm 3, Pemetrexed maintenance therapy can be given either q3w or q4w (dependent on Investigator decision and local standards)] until objective disease progression.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Tumor scans performed at baseline, Week 6, Week 12 and then every 8 weeks relative to date of randomization until radiological progression. Assessed until global cohort DCO of 24 July 2019 (maximum of approximately 25 months).

Title

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

Description

Time Frame

From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).

Secondary Outcome Measure Information:

Title

PFS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC

Description

Time Frame

Title

OS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC

Description

Time Frame

From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).

Title

Objective Response Rate (ORR)

Description

Time Frame

Title

Best Objective Response (BoR)

Description

Time Frame

Title

Duration of Response (DoR)

Description

Time Frame

Title

Time From Randomization to Second Progression (PFS2)

Description

Time Frame

Title

Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations

Description

Time Frame

Samples were collected post-dose on Day 1 (Week 0), pre-dose on Weeks 3 and 12 and at follow-up (3 months after the last valid dose). Assessed at the global cohort DCO of 12 March 2021.

Title

PK of Tremelimumab; Peak and Trough Serum Concentrations

Description

Time Frame

Samples were collected post-dose on Day 1 (Week 0), pre-dose on Weeks 3 and 12 and at follow-up (3 months after the last valid dose). Assessed at the global cohort DCO of 12 March 2021.

Title

Number of Patients With Anti-Drug Antibody (ADA) Response to Durvalumab

Description

Time Frame

Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of study treatment (ie, durvalumab).

Title

Number of Patients With ADA Response to Tremelimumab

Description

Time Frame

Samples were collected on Day 1 (Week 0), Week 12 and at 3 months after the last dose of study treatment (ie, tremelimumab).

Title

Description

Time Frame

At baseline, Weeks 3, 6, 9, 12, 16 and 20, then Q4W until PD, on Day 28 and 2 months post-PD, then every 8 weeks until second progression/death (whichever came first). Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).

Title

Time to Deterioration of PRO Symptoms, Assessed Using EORTC QLQ-Lung Cancer Module 13 (QLQ-LC13)

Description

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

130 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: For inclusion in the study, patients should fulfill the following criteria: Aged at least 18 years. Histologically or cytologically documented Stage IV NSCLC. Confirmed tumor PD-L1 status prior to randomization. Patients must have tumors that lack activating EGFR mutations and ALK fusions. No prior chemotherapy or any other systemic therapy for metastatic NSCLC. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 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: Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant. Active or prior documented autoimmune or inflammatory disorders. Brain metastases or spinal cord compression unless the patient's condition is stable and off steroids. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaojin Shi, M.D., MSc

Organizational Affiliation

One MedImmune Way, Gaithersburg, Maryland 20878, United States

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85054

Country

United States

Facility Name

Research Site

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Research Site

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Research Site

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33901

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Research Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33705

Country

United States

Facility Name

Research Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Research Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Research Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64132

Country

United States

Facility Name

Research Site

City

Canton

State/Province

Ohio

ZIP/Postal Code

44710

Country

United States

Facility Name

Research Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Facility Name

Research Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Research Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Research Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77090

Country

United States

Facility Name

Research Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

Research Site

City

Barretos

ZIP/Postal Code

14784-400

Country

Brazil

Facility Name

Research Site

City

Belo Horizonte

ZIP/Postal Code

30380-472

Country

Brazil

Facility Name

Research Site

City

Curitiba

ZIP/Postal Code

81520-060

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

90035-003

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

Research Site

City

Porto Alegre

ZIP/Postal Code

91350-200

Country

Brazil

Facility Name

Research Site

City

Ribeirao Preto

ZIP/Postal Code

14015-140

Country

Brazil

Facility Name

Research Site

City

Rio de Janeiro

ZIP/Postal Code

20231-050

Country

Brazil

Facility Name

Research Site

City

Santo Andre

ZIP/Postal Code

09080-110

Country

Brazil

Facility Name

Research Site

City

Santo André

ZIP/Postal Code

09060-650

Country

Brazil

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

01209-000

Country

Brazil

Facility Name

Research Site

City

Sao Paulo

ZIP/Postal Code

01246-000

Country

Brazil

Facility Name

Research Site

City

São José do Rio Preto

ZIP/Postal Code

15090-000

Country

Brazil

Facility Name

Research Site

City

São Paulo

ZIP/Postal Code

03102-002

Country

Brazil

Facility Name

Research Site

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Research Site

City

Plovdiv

ZIP/Postal Code

4004

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1330

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1618

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

Research Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Research Site

City

Beijing

ZIP/Postal Code

100021

Country

China

Facility Name

Research Site

City

Beijing

ZIP/Postal Code

100142

Country

China

Facility Name

Research Site

City

Changchun

ZIP/Postal Code

130012

Country

China

Facility Name

Research Site

City

Changsha

ZIP/Postal Code

410013

Country

China

Facility Name

Research Site

City

Fuzhou

ZIP/Postal Code

350014

Country

China

Facility Name

Research Site

City

Guangzhou

ZIP/Postal Code

510080

Country

China

Facility Name

Research Site

City

Hangzhou

ZIP/Postal Code

310022

Country

China

Facility Name

Research Site

City

Harbin

ZIP/Postal Code

150081

Country

China

Facility Name

Research Site

City

Hefei

ZIP/Postal Code

230601

Country

China

Facility Name

Research Site

City

Kunming

ZIP/Postal Code

CN-650034

Country

China

Facility Name

Research Site

City

Linyi

ZIP/Postal Code

276000

Country

China

Facility Name

Research Site

City

Liuzhou

ZIP/Postal Code

545006

Country

China

Facility Name

Research Site

City

Nanjing

ZIP/Postal Code

210009

Country

China

Facility Name

Research Site

City

Qingdao

ZIP/Postal Code

110016

Country

China

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200030

Country

China

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200080

Country

China

Facility Name

Research Site

City

Shantou

ZIP/Postal Code

515041

Country

China

Facility Name

Research Site

City

Wuhan

ZIP/Postal Code

430022

Country

China

Facility Name

Research Site

City

Wuhan

ZIP/Postal Code

430079

Country

China

Facility Name

Research Site

City

Xining

ZIP/Postal Code

810001

Country

China

Facility Name

Research Site

City

Yangzhou

ZIP/Postal Code

225001

Country

China

Facility Name

Research Site

City

Zhanjiang

ZIP/Postal Code

524001

Country

China

Facility Name

Research Site

City

Zhengzhou

ZIP/Postal Code

450008

Country

China

Facility Name

Research Site

City

Zhengzhou

ZIP/Postal Code

450052

Country

China

Facility Name

Research Site

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Research Site

City

Essen

ZIP/Postal Code

45122

Country

Germany

Facility Name

Research Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Research Site

City

Gauting

ZIP/Postal Code

82131

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

20251

Country

Germany

Facility Name

Research Site

City

Hamburg

ZIP/Postal Code

21075

Country

Germany

Facility Name

Research Site

City

Heidelberg

ZIP/Postal Code

69126

Country

Germany

Facility Name

Research Site

City

Immenhausen

ZIP/Postal Code

34376

Country

Germany

Facility Name

Research Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Research Site

City

Oldenburg

ZIP/Postal Code

26121

Country

Germany

Facility Name

Research Site

City

Würzburg

ZIP/Postal Code

97067

Country

Germany

Facility Name

Research Site

City

Shatin

ZIP/Postal Code

00000

Country

Hong Kong

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1121

Country

Hungary

Facility Name

Research Site

City

Kecskemét

ZIP/Postal Code

6000

Country

Hungary

Facility Name

Research Site

City

Miskolc

ZIP/Postal Code

3529

Country

Hungary

Facility Name

Research Site

City

Törökbálint

ZIP/Postal Code

2045

Country

Hungary

Facility Name

Research Site

City

Bunkyo-ku

ZIP/Postal Code

113-8603

Country

Japan

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Research Site

City

Fukuoka-shi

ZIP/Postal Code

812-8582

Country

Japan

Facility Name

Research Site

City

Hiroshima-shi

ZIP/Postal Code

730-0011

Country

Japan

Facility Name

Research Site

City

Iwakuni-shi

ZIP/Postal Code

740-8510

Country

Japan

Facility Name

Research Site

City

Kanazawa

ZIP/Postal Code

920-8641

Country

Japan

Facility Name

Research Site

City

Kashiwa

ZIP/Postal Code

227-8577

Country

Japan

Facility Name

Research Site

City

Koto-ku

ZIP/Postal Code

135-8550

Country

Japan

Facility Name

Research Site

City

Kurume-shi

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

Research Site

City

Matsuyama-shi

ZIP/Postal Code

790-0007

Country

Japan

Facility Name

Research Site

City

Okayama-shi

ZIP/Postal Code

700-8558

Country

Japan

Facility Name

Research Site

City

Okayama-shi

ZIP/Postal Code

700-8607

Country

Japan

Facility Name

Research Site

City

Osakasayama

ZIP/Postal Code

589-8511

Country

Japan

Facility Name

Research Site

City

Sapporo-shi

ZIP/Postal Code

003-0804

Country

Japan

Facility Name

Research Site

City

Sunto-gun

ZIP/Postal Code

411-8777

Country

Japan

Facility Name

Research Site

City

Toyoake-shi

ZIP/Postal Code

470-1101

Country

Japan

Facility Name

Research Site

City

Ube-shi

ZIP/Postal Code

755-0241

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

236-0004

Country

Japan

Facility Name

Research Site

City

Yokohama-shi

ZIP/Postal Code

241-8515

Country

Japan

Facility Name

Research Site

City

Busan

ZIP/Postal Code

47392

Country

Korea, Republic of

Facility Name

Research Site

City

Chungcheongbuk-do

ZIP/Postal Code

28644

Country

Korea, Republic of

Facility Name

Research Site

City

Daegu

ZIP/Postal Code

42415

Country

Korea, Republic of

Facility Name

Research Site

City

Incheon

ZIP/Postal Code

21565

Country

Korea, Republic of

Facility Name

Research Site

City

Seongnam-si

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

6351

Country

Korea, Republic of

Facility Name

Research Site

City

Ulsan

ZIP/Postal Code

44033

Country

Korea, Republic of

Facility Name

Research Site

City

Aguascalientes

ZIP/Postal Code

20230

Country

Mexico

Facility Name

Research Site

City

Cuautitlan Izcalli

ZIP/Postal Code

54769

Country

Mexico

Facility Name

Research Site

City

Guadalajara

ZIP/Postal Code

44280

Country

Mexico

Facility Name

Research Site

City

Mexico City

ZIP/Postal Code

0 3100

Country

Mexico

Facility Name

Research Site

City

Mexico

ZIP/Postal Code

14080

Country

Mexico

Facility Name

Research Site

City

Monterrey

ZIP/Postal Code

64060

Country

Mexico

Facility Name

Research Site

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Research Site

City

México

ZIP/Postal Code

04739

Country

Mexico

Facility Name

Research Site

City

Tuxtla

ZIP/Postal Code

29030

Country

Mexico

Facility Name

Research Site

City

Arequipa

ZIP/Postal Code

AREQUIPA01

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

L27

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 29

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 34

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 41

Country

Peru

Facility Name

Research Site

City

San Isidro

ZIP/Postal Code

Country

Peru

Facility Name

Research Site

City

Olsztyn

ZIP/Postal Code

10-357

Country

Poland

Facility Name

Research Site

City

Tomaszów Mazowiecki

ZIP/Postal Code

97-200

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

Research Site

City

Wodzisław Śląski

ZIP/Postal Code

44-300

Country

Poland

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

105229

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

115280

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

125367

Country

Russian Federation

Facility Name

Research Site

City

Omsk

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

195271

Country

Russian Federation

Facility Name

Research Site

City

Saint-Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Research Site

City

Sankt-Peterburg

ZIP/Postal Code

196603

Country

Russian Federation

Facility Name

Research Site

City

St. Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Research Site

City

Durban

ZIP/Postal Code

4091

Country

South Africa

Facility Name

Research Site

City

Johannesburg

ZIP/Postal Code

0001

Country

South Africa

Facility Name

Research Site

City

Kraaifontein

ZIP/Postal Code

7570

Country

South Africa

Facility Name

Research Site

City

Parktown

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Research Site

City

Pretoria

ZIP/Postal Code

0001

Country

South Africa

Facility Name

Research Site

City

Rondebosch

ZIP/Postal Code

7700

Country

South Africa

Facility Name

Research Site

City

Vereeniging

ZIP/Postal Code

1930

Country

South Africa

Facility Name

Research Site

City

Changhua City

ZIP/Postal Code

50006

Country

Taiwan

Facility Name

Research Site

City

Kaohsiung City

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Research Site

City

Kaohsiung

ZIP/Postal Code

82445

Country

Taiwan

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

40705

Country

Taiwan

Facility Name

Research Site

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

235

Country

Taiwan

Facility Name

Research Site

City

Tao-Yuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Research Site

City

Bangkok

ZIP/Postal Code

10210

Country

Thailand

Facility Name

Research Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Research Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Research Site

City

Muang

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Research Site

City

Songkhla

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Research Site

City

Dnipro

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

Research Site

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

Research Site

City

Kirovohrad

ZIP/Postal Code

25006

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

03022

Country

Ukraine

Facility Name

Research Site

City

Kyiv

ZIP/Postal Code

03115

Country

Ukraine

Facility Name

Research Site

City

Lviv

ZIP/Postal Code

79031

Country

Ukraine

Facility Name

Research Site

City

Odesa

ZIP/Postal Code

65055

Country

Ukraine

Facility Name

Research Site

City

Sumy

ZIP/Postal Code

40022

Country

Ukraine

Facility Name

Research Site

City

Vinnytsia

ZIP/Postal Code

21029

Country

Ukraine

Facility Name

Research Site

City

Zaporizhzhia

ZIP/Postal Code

69040

Country

Ukraine

Facility Name

Research Site

City

Leicester

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

EC1M 6BQ

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

NW1 2PG

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

Research Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Research Site

City

Hanoi

ZIP/Postal Code

100000

Country

Vietnam

Facility Name

Research Site

City

Ho Chi Minh

ZIP/Postal Code

700000

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

Citations:

PubMed Identifier

36327426

Citation

Johnson ML, Cho BC, Luft A, Alatorre-Alexander J, Geater SL, Laktionov K, Kim SW, Ursol G, Hussein M, Lim FL, Yang CT, Araujo LH, Saito H, Reinmuth N, Shi X, Poole L, Peters S, Garon EB, Mok T; POSEIDON investigators. Durvalumab With or Without Tremelimumab in Combination With Chemotherapy as First-Line Therapy for Metastatic Non-Small-Cell Lung Cancer: The Phase III POSEIDON Study. J Clin Oncol. 2023 Feb 20;41(6):1213-1227. doi: 10.1200/JCO.22.00975. Epub 2022 Nov 3.

Results Reference

derived

Links:

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D419MC00004&attachmentIdentifier=7d96582a-99c4-430c-8f40-cb5baed12064&fileName=Redacted_-_D419MC00004_-___Statistical_Analysis_Plan.pdf&versionIdentifier=

Description

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URL

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Description

Related Info

URL

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Description

Related Info

Learn more about this trial

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

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

Non Small Cell Lung Cancer NSCLC

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial