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

NCT ID: NCT03164616

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2027-11-15

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.

Conditions

Non Small Cell Lung Cancer NSCLC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm 1

durvalumab + tremelimumab combination therapy + SoC chemotherapy

Group Type: EXPERIMENTAL

Durvalumab

Intervention Type: DRUG

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

Tremelimumab

Intervention Type: DRUG

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

Abraxane + carboplatin

Intervention Type: DRUG

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).

Gemcitabine + cisplatin

Intervention Type: DRUG

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).

Gemcitabine + carboplatin

Intervention Type: DRUG

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).

Pemetrexed + carboplatin

Intervention Type: DRUG

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.

Pemetrexed + cisplatin

Intervention Type: DRUG

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.

Treatment Arm 2

durvalumab monotherapy + SoC chemotherapy

Group Type: EXPERIMENTAL

Durvalumab

Intervention Type: DRUG

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

Abraxane + carboplatin

Intervention Type: DRUG

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).

Gemcitabine + cisplatin

Intervention Type: DRUG

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).

Gemcitabine + carboplatin

Intervention Type: DRUG

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).

Pemetrexed + carboplatin

Intervention Type: DRUG

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.

Pemetrexed + cisplatin

Intervention Type: DRUG

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.

Treatment Arm 3

SoC chemotherapy alone

Group Type: ACTIVE_COMPARATOR

Abraxane + carboplatin

Intervention Type: DRUG

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).

Gemcitabine + cisplatin

Intervention Type: DRUG

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).

Gemcitabine + carboplatin

Intervention Type: DRUG

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).

Pemetrexed + carboplatin

Intervention Type: DRUG

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.

Pemetrexed + cisplatin

Intervention Type: DRUG

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.

Interventions

Durvalumab

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

Tremelimumab

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

Abraxane + carboplatin

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

Gemcitabine + cisplatin

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

Gemcitabine + carboplatin

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

Pemetrexed + carboplatin

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

Pemetrexed + cisplatin

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.

Intervention Type: DRUG

Eligibility 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 130 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaojin Shi, M.D., MSc

Role: STUDY_DIRECTOR

One MedImmune Way, Gaithersburg, Maryland 20878, United States

Locations

Research Site

Phoenix, Arizona, United States

Research Site

Bakersfield, California, United States

Research Site

Santa Monica, California, United States

Research Site

Fort Myers, Florida, United States

Research Site

Jacksonville, Florida, United States

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St. Petersburg, Florida, United States

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West Palm Beach, Florida, United States

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Louisville, Kentucky, United States

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Kansas City, Missouri, United States

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Canton, Ohio, United States

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Pittsburgh, Pennsylvania, United States

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Chattanooga, Tennessee, United States

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Nashville, Tennessee, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Richmond, Virginia, United States

Research Site

Barretos, , Brazil

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Belo Horizonte, , Brazil

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Curitiba, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre, , Brazil

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Ribeirão Preto, , Brazil

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Rio de Janeiro, , Brazil

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Santo André, , Brazil

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Santo André, , Brazil

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São José do Rio Preto, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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São Paulo, , Brazil

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Plovdiv, , Bulgaria

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Beijing, , China

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Beijing, , China

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Changchun, , China

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Changsha, , China

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Fuzhou, , China

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Guangzhou, , China

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Hangzhou, , China

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Harbin, , China

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Hefei, , China

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Kunming, , China

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Linyi, , China

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Liuzhou, , China

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Nanjing, , China

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Qingdao, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Shantou, , China

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Wuhan, , China

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Wuhan, , China

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Xining, , China

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Yangzhou, , China

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Zhanjiang, , China

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Zhengzhou, , China

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Zhengzhou, , China

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Berlin, , Germany

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Essen, , Germany

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Freiburg im Breisgau, , Germany

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Gauting, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Immenhausen, , Germany

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Mainz, , Germany

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Oldenburg, , Germany

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Würzburg, , Germany

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Shatin, , Hong Kong

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Budapest, , Hungary

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Budapest, , Hungary

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Kecskemét, , Hungary

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Miskolc, , Hungary

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Törökbálint, , Hungary

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Bunkyō City, , Japan

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Chūōku, , Japan

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Fukuoka, , Japan

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Hiroshima, , Japan

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Iwakuni-shi, , Japan

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Kanazawa, , Japan

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Kashiwa, , Japan

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Kōtoku, , Japan

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Kurume-shi, , Japan

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Matsuyama, , Japan

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Okayama, , Japan

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Okayama, , Japan

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Sapporo, , Japan

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Sayama, , Japan

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Sunto-gun, , Japan

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Toyoake-shi, , Japan

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Ube-shi, , Japan

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Yokohama, , Japan

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Yokohama, , Japan

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Aguascalientes, , Mexico

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Cuautitlán Izcalli, , Mexico

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Guadalajara, , Mexico

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Mexico City, , Mexico

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México, , Mexico

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México, , Mexico

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Monterrey, , Mexico

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Monterrey, , Mexico

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Tuxtla Gutiérrez, , Mexico

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Arequipa, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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Lima, , Peru

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San Isidro, , Peru

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Olsztyn, , Poland

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Tomaszów Mazowiecki, , Poland

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Warsaw, , Poland

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Wodzisław Śląski, , Poland

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Omsk, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Cape Town, , South Africa

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Durban, , South Africa

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Johannesburg, , South Africa

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Parktown, , South Africa

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Pretoria, , South Africa

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Rondebosch, , South Africa

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Vereeniging, , South Africa

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Busan, , South Korea

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Chungcheongbuk-do, , South Korea

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Daegu, , South Korea

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Incheon, , South Korea

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Seongnam-si, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

Research Site

Ulsan, , South Korea

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Changhua, , Taiwan

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Kaohsiung City, , Taiwan

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Kaohsiung City, , Taiwan

Research Site

Taichung, , Taiwan

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Taichung, , Taiwan

Research Site

Tainan City, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

Research Site

Taipei, , Taiwan

Research Site

Taoyuan District, , Taiwan

Research Site

Bangkok, , Thailand

Research Site

Bangkok, , Thailand

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Bangkok, , Thailand

Research Site

Muang, , Thailand

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Songkhla, , Thailand

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Dnipro, , Ukraine

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Ivano-Frankivsk, , Ukraine

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Kirovohrad, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Sumy, , Ukraine

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Vinnytsia, , Ukraine

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Zaporizhzhia, , Ukraine

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Leicester, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Hanoi, , Vietnam

Research Site

Ho Chi Minh City, , Vietnam

Countries

United States; Brazil; Bulgaria; China; Germany; Hong Kong; Hungary; Japan; Mexico; Peru; Poland; Russia; South Africa; South Korea; Taiwan; Thailand; Ukraine; United Kingdom; Vietnam

References

He JZ, Duval V, Jauslin P, Goncalves A, Abegesah A, Fan C, Lim K, Song X, Chen C, Shi X, Mann H, Krug L, Ren S, Phipps A, Gibbs M, Zhou D. Population Pharmacokinetics and Exposure-Response Analysis for the CTLA-4 Inhibitor Tremelimumab in Metastatic NSCLC Patients in the Phase III POSEIDON Study. Clin Pharmacol Ther. 2023 Dec;114(6):1375-1386. doi: 10.1002/cpt.3063. Epub 2023 Oct 17.

Reference Type: DERIVED

PMID: 37777827 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36327426 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

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Other Identifiers

2017-000920-81

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D419MC00004

Identifier Type: -

Identifier Source: org_study_id