Clinical Trial: NCT03003962 - My Cancer Genome

NCT03003962

Description:

This is a randomized, open-label, multi-center Phase III study to determine the efficacy and safety of durvalumab versus platinum-based SoC chemotherapy in the first-line treatment of advanced NSCLC in patients who are epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type and with PD-L1 high expression (PEARL)

Related Conditions:

Non-Small Cell Lung Carcinoma

Recruiting Status:

Active, not recruiting

Phase:

Phase 3

URL:

https://clinicaltrials.gov/show/NCT03003962

Trial Eligibility

Document

Title

Brief Title: Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)
Official Title: A Phase III Randomized, Open-Label, Multi-Center Study of Durvalumab (MEDI4736) Versus Standard of Care (SoC) Platinum-Based Chemotherapy as First Line Treatment in Patients With PD-L1-High Expression Advanced Non Small-Cell Lung Cancer

Clinical Trial IDs

ORG STUDY ID: D419AC00002
NCT ID: NCT03003962

Conditions

Non Small Cell Lung Carcinoma NSCLC

Interventions

Drug	Synonyms	Arms
Durvalumab (MEDI4736)		Arm 1: Durvalumab
Paclitaxel + carboplatin	Platinum based Standard of Care Chemotherapy	Arm 2: Standard of Care
Gemcitabine + cisplatin	Platinum based Standard of Care Chemotherapy	Arm 2: Standard of Care
Gemcitabine + carboplatin	Platinum based Standard of Care Chemotherapy	Arm 2: Standard of Care
Pemetrexed + cisplatin	Platinum based Standard of Care Chemotherapy	Arm 2: Standard of Care
Pemetrexed + carboplatin	Platinum based Standard of Care Chemotherapy	Arm 2: Standard of Care

Purpose

Detailed Description

      Patients with stage IV NSCLC will be randomized in a 1:1 ratio to 2 treatment arms
      (durvalumab or SOC therapy). The dual primary objectives of this study are to assess the
      efficacy of durvalumab versus SoC in terms of OS (Overall Survival) in all randomized
      patients and in patients who are at low risk of EM (early mortality)

Trial Arms

Name	Type	Description	Interventions
Arm 1: Durvalumab	Experimental	Anti-PD-L1 monoclonal Antibody monotherapy	Durvalumab (MEDI4736)
Arm 2: Standard of Care	Active Comparator	Standard of Care Platinum-Based chemotherapy	Paclitaxel + carboplatin Gemcitabine + cisplatin Gemcitabine + carboplatin Pemetrexed + cisplatin Pemetrexed + carboplatin

Eligibility Criteria

        Inclusion Criteria

          -  Aged at least 18 years

          -  Documented evidence of Stage IV NSCLC

          -  No sensitizing EGFR mutation and ALK rearrangement

          -  PD-L1 high expression

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Prior chemotherapy or any other systemic therapy for advanced NSCLC

          -  Prior exposure to immune-mediated therapy, including, but not limited to, other
             anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1
             (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies,
             excluding therapeutic anticancer vaccines

          -  Brain metastases or spinal cord compression unless the patient is stable and off
             steroids for at least 14 days prior to start of study treatment

          -  Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant

          -  Active or prior documented autoimmune or inflammatory disorders (e.g., colitis or
             Crohn's disease]

Maximum Eligible Age:	130 Years
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	The efficacy of Durvalumab therapy compared to SoC in terms of Overall Survival (OS) in all randomized patients
Time Frame:	4 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:	The efficacy of Durvalumab compared to SoC in terms of Objective response rate (ORR)
Time Frame:	4 years
Safety Issue:
Description:

Measure:	The efficacy of Durvalumab compared to SoC in terms of Duration of response (DoR)
Time Frame:	4 years
Safety Issue:
Description:

Measure:	The efficacy of Durvalumab compared to SoC in terms of A Proportion of patients alive and progression free at 12 months from randomization (APF12)
Time Frame:	12 months
Safety Issue:
Description:

Measure:	The efficacy of Durvalumab compared to SoC in terms of Progression-free survival after subsequent anticancer therapy (PFS2)
Time Frame:	4 years
Safety Issue:
Description:

Measure:	Disease-related symptoms and health-related quality of life in subjects treated with durvalumab compared to SoC using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire
Time Frame:	4 years
Safety Issue:
Description:

Measure:	The immunogenicity of durvalumab by measuring the presence of Anti-drug Antibodies
Time Frame:	4 years
Safety Issue:
Description:

Measure:	The efficacy of Durvalumab therapy compared to SoC in terms of progress-free survival (PFS) in patients with NSCLC
Time Frame:	4 years
Safety Issue:
Description:

Measure:	The efficacy of Durvalumab therapy compared to SoC in terms of Overall Survival (OS) in PD-L1 high patients and in PD-L1 high with low risk of EM population
Time Frame:	4 years
Safety Issue:
Description:

Measure:	Proportion of patients alive at 18 months from randomization (OS18)
Time Frame:	18 months
Safety Issue:
Description:

Measure:	Proportion of patients alive at 24 months from randomization (OS24)
Time Frame:	24 months
Safety Issue:
Description:

Details

Phase:	Phase 3
Primary Purpose:	Interventional
Overall Status:	Active, not recruiting
Lead Sponsor:	AstraZeneca

Trial Keywords

NSCLC
PD-L1
Durvalumab (MEDI4736)
OS

Last Updated

May 3, 2021

Clinical Trials /

Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)