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PD-L1 Inhibitor

Durvalumab vs Chemotherapy for Non-Small Cell Lung Cancer

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
PD-L1 high expression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug against standard chemotherapy to see if it is more effective and has less side effects.

Who is the study for?
This trial is for adults with Stage IV Non-Small Cell Lung Cancer (NSCLC) who have not had prior treatment, do not have certain gene mutations (EGFR/ALK), and show high PD-L1 expression. It's not for those with a history of significant autoimmune diseases, untreated brain metastases, or previous immune therapy.Check my eligibility
What is being tested?
The study compares the effectiveness and safety of Durvalumab alone versus various combinations of chemotherapy drugs in first-line treatment. Patients are randomly assigned to receive either Durvalumab or one of several standard chemo options.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects like inflammation in different body parts, skin reactions, hormone gland problems, and infusion reactions. Chemotherapy can lead to hair loss, nausea, fatigue, increased risk of infection and blood cell changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer shows high PD-L1 expression.
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I am 18 years old or older.
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My condition is Stage IV non-small cell lung cancer.
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My cancer does not have EGFR mutations or ALK rearrangements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
OS in Participants With LREM
Overall Survival (OS)
Secondary outcome measures
APF12 in PD-L1 TC >= 25% LREM Analysis Set
APF12 in PD-L1 TC >= 50% Analysis Set
APF12 in PD-L1 TC >= 50% LREM Analysis Set
+39 more
Other outcome measures
The Incidence of Treatment-Emergent Adverse Events assessed by Common Terminology Criteria for Adverse Event (CTCAE) v4.03 for subjects receiving Durvalumab therapy or SoC

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: DurvalumabExperimental Treatment1 Intervention
Anti-PD-L1 monoclonal Antibody monotherapy
Group II: Arm 2: Standard of CareActive Control5 Interventions
Standard of Care Platinum-Based chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab (MEDI4736)
2018
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,238 Previous Clinical Trials
288,470,752 Total Patients Enrolled
Shire NorahStudy DirectorAstraZeneca GMD IO, Gaitherburg, MD, USA
Parker SuzanneStudy DirectorAstraZeneca RDM, South San Francisco, USA

Media Library

Durvalumab (MEDI4736) (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03003962 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Arm 1: Durvalumab, Arm 2: Standard of Care
Non-Small Cell Lung Cancer Clinical Trial 2023: Durvalumab (MEDI4736) Highlights & Side Effects. Trial Name: NCT03003962 — Phase 3
Durvalumab (MEDI4736) (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03003962 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study hope to include patients who are elderly?

"The current recruitment effort is focused on patients that are between 18 and 130 years old."

Answered by AI

Is this study actively looking for participants?

"Unfortunately, this particular clinical trial is not presently looking for candidates. The study was initially posted on 1/2/2017 and updated for the last time on 10/19/2022. However, if you are exploring other studies, there are currently 1559 trials actively recruiting patients with non-small cell lung carcinoma (nsclc) and 1916 studies for Durvalumab (MEDI4736) enrolling participants."

Answered by AI

Might there be any adverse effects to treatment with Durvalumab (MEDI4736)?

"There is both preclinical and clinical evidence to support the safety of Durvalumab (MEDI4736), which our team has rated as a 3."

Answered by AI

Could I take part in this experiment if I wanted to?

"The ideal candidate for this clinical trial would have non-small cell lung carcinoma (nsclc), and be between 18-130 years old. Currently, the team is looking to recruit 671 patients in total."

Answered by AI

For what purpose is Durvalumab (MEDI4736) often utilized?

"Durvalumab (MEDI4736) can be used to treat cancer in the fallopian tubes, as well as other diseases and conditions."

Answered by AI

How many people can join this clinical trial at its maximum enrollment?

"Unfortunately, this particular study is no longer looking for participants. The trial was posted on January 2nd, 2017 and last updated on October 19th, 2022. However, there are many other studies which may be of interest; 1559 trials for non-small cell lung carcinoma (nsclc) and 1916 involving Durvalumab (MEDI4736) are currently ongoing and actively recruiting patients."

Answered by AI
~82 spots leftby Mar 2025