A study of Durvalumab Versus Standard of Care in Advanced Non Small-Cell Lung Cancer

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 (NSCLC) - Pearl

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001375-21-NL

Enrollment

650

Registered

2018-05-16

Start date

2018-06-28

Completion date

Unknown

Last updated

2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

First line patients with Advanced Non Small-Cell Lung Cancer (NSCLC) with PD-L1 positive membrane expression in tumoral tissue and lacking activating epdermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) infusions. MedDRA version: 20.0 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864

Interventions

Product Name: Durvalumab Product Code: MEDI4736 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Durvalumab CAS Number: 1428935-60-7 Current Sponsor code: MEDI4736 Other

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Aged at least 18 years - Documented evidence of Stage IV NSCLC - No sensitizing EGFR mutation or ALK rearrangement - PD-L1 positive expression status, prior to randomization, defined as PD-L1 high membrane expression in tumoral tissue with the Ventana SP263 PD-L1 IHC assay determined by a reference laboratory - No prior chemotherapy or any other systemic therapy for advanced or metastatic NSCLC - World Health Organization (WHO) Performance Status of 0 or 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 430 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 220

Exclusion criteria

Exclusion criteria: • Prior chemotherapy or any other systemic therapy for advanced NSCLC • Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant • Brain metastases or spinal cord compression unless the patient is stable (asymptomatic, no evidence of new or emerging brain metastases) and off steroids for at least 14 days prior to start of study treatment • Prior exposure to Immunomodulatory therapy (IMT), 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 • Active or prior documented inflammatory bowel disease • Active infection • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of durvalumab compared to Standard of care (Soc) chemotherapy;Secondary Objective: 1. To assess the efficacy of durvalumab compared to SoC in terms of Overall survival (OS) in PD-L1 high patients 2. To assess the efficacy of durvalumab compared to SoC in terms of Progression-free survival (PFS), Objective response rate (ORR), Duration of response (DoR), Proportion of patients alive and progression free at 12 months from randomization (APF12), and Progression-free survival after subsequent anticancer therapy (PFS2) 3.To assess disease-related symptoms and Health-related quality of life (HRQoL) in patients treated with durvalumab compared to SoC using the European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire, version 3 (QLQ-C30 v3) and the 13-item lung cancer quality of life questionnaire (LC13) module 4. To investigate the immunogenicity of durvalumab;Primary end point(s): OS;Timepoint(s) of evaluation of this end point: The final (primary) analysis of OS will be performed when at minimum 520 OS events have occurred across the durvalumab and SoC treatment groups.	—

Measure

Time frame

Main Objective: To assess the efficacy of durvalumab compared to Standard of care (Soc) chemotherapy;Secondary Objective: 1. To assess the efficacy of durvalumab compared to SoC in terms of Overall survival (OS) in PD-L1 high patients 2. To assess the efficacy of durvalumab compared to SoC in terms of Progression-free survival (PFS), Objective response rate (ORR), Duration of response (DoR), Proportion of patients alive and progression free at 12 months from randomization (APF12), and Progression-free survival after subsequent anticancer therapy (PFS2) 3.To assess disease-related symptoms and Health-related quality of life (HRQoL) in patients treated with durvalumab compared to SoC using the European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality of life questionnaire, version 3 (QLQ-C30 v3) and the 13-item lung cancer quality of life questionnaire (LC13) module 4. To investigate the immunogenicity of durvalumab;Primary end point(s): OS;Timepoint(s) of evaluation of this end point: The final (primary) analysis of OS will be performed when at minimum 520 OS events have occurred across the durvalumab and SoC treatment groups.

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Secondary

Measure	Time frame
Secondary end point(s): Overall survival Progression-free survival (PFS) using investigator assessments according to RECIST 1.1 Objective response rate (ORR) using investigator assessments according to RECIST 1.1 Duration of response (DoR) using investigator assessments according to RECIST 1.1 Proportion of patients alive and progression free at 12 months from randomization (APF12) using investigator assessments according to RECIST 1.1 Progression-free survival after subsequent anticancer therapy (PFS2) Health-related QoL measured by EORTC QLQ-C30 v3 Disease-related symptoms measured by EORTC QLQ-LC13 Changes in WHO/ECOG performance status The immunogenicity of durvalumab as assessed by presence of anti-drug antibodies (ADAs);Timepoint(s) of evaluation of this end point: Until end of study	—

Measure

Time frame

Secondary end point(s): Overall survival Progression-free survival (PFS) using investigator assessments according to RECIST 1.1 Objective response rate (ORR) using investigator assessments according to RECIST 1.1 Duration of response (DoR) using investigator assessments according to RECIST 1.1 Proportion of patients alive and progression free at 12 months from randomization (APF12) using investigator assessments according to RECIST 1.1 Progression-free survival after subsequent anticancer therapy (PFS2) Health-related QoL measured by EORTC QLQ-C30 v3 Disease-related symptoms measured by EORTC QLQ-LC13 Changes in WHO/ECOG performance status The immunogenicity of durvalumab as assessed by presence of anti-drug antibodies (ADAs);Timepoint(s) of evaluation of this end point: Until end of study

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Countries

Australia, China, Hungary, Korea, Republic of, Netherlands, Poland, Russian Federation, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam

Contacts

Public ContactInformation Center

AstraZeneca AB

information.center@astrazeneca.com+18772409479

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026