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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2024
• Main ID: NCT03164616
• Date of registration: 22/05/2017
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON). POSEIDON
• Scientific 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)
• Date of first enrolment: June 1, 2017
• Target sample size: 1186
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03164616
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Brazil, Bulgaria, China, Germany, Hong Kong, Hungary, Japan, Korea, Republic of, Mexico, Peru, Poland, Russian Federation, South Africa, Taiwan, Thailand, Ukraine, United Kingdom, United States, Vietnam

Contacts

• Name: Xiaojin Shi, M.D., MSc
• Affiliation: One MedImmune Way, Gaithersburg, Maryland 20878, United States

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 130 Years
Gender: All

Health Condition(s) or Problem(s) studied

Non Small Cell Lung Cancer NSCLC

Intervention(s)

Drug: Gemcitabine + cisplatin

Drug: Pemetrexed + carboplatin

Drug: Durvalumab

Drug: Abraxane + carboplatin

Drug: Gemcitabine + carboplatin

Drug: Tremelimumab

Drug: Pemetrexed + cisplatin

Primary Outcome(s)

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

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

Time From Randomization to Second Progression (PFS2) [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).]

Best Objective Response (BoR) [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).]

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

Duration of Response (DoR) [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).]

Objective Response Rate (ORR) [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).]

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) [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).]

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

PFS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC [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.]

Number of Patients With ADA Response to Tremelimumab [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).]

OS; T + D + SoC Compared With SoC Alone and T + D + SoC Compared With D + SoC [Time Frame: From baseline until death due to any cause. Assessed until global cohort DCO of 12 March 2021 (maximum of approximately 45 months).]

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

PK of Tremelimumab; Peak and Trough Serum Concentrations [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.]

Secondary ID(s)

D419MC00004

2017-000920-81

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 07/04/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03164616