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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
Must not have
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
Active or prior documented autoimmune or inflammatory disorders (e.g., colitis or Crohn's disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Summary
This trial is testing durvalumab, an immunotherapy drug, in patients with advanced lung cancer who do not have certain genetic mutations and have high levels of a specific protein. The drug helps the immune system see and fight the cancer better.
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have stable brain or spinal metastases and haven't taken steroids for 14 days.
Select...
I have or had an autoimmune or inflammatory disorder like colitis.
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I have not had chemotherapy or any systemic therapy for advanced NSCLC.
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My lung cancer is a mix of small-cell and non-small cell types.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
OS in Participants With LREM
Overall Survival (OS)
Secondary study objectives
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 moreOther study objectives
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapies, chemotherapy, and targeted therapies. Immunotherapies, such as PD-L1 inhibitors like Durvalumab, work by blocking the PD-L1 protein on cancer cells, which helps the immune system recognize and attack these cells.
This is crucial for NSCLC patients as it can enhance the body's natural defenses against cancer. Chemotherapy uses drugs to kill rapidly dividing cancer cells, but it also affects normal cells, leading to side effects.
Targeted therapies focus on specific genetic mutations in cancer cells, such as EGFR or ALK mutations, and inhibit their growth and survival. These treatments are tailored to the genetic profile of the tumor, making them effective for certain subsets of NSCLC patients.
Understanding these mechanisms helps in selecting the most appropriate treatment strategy, improving outcomes and minimizing side effects.
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,368 Previous Clinical Trials
288,736,090 Total Patients Enrolled
Shire NorahStudy DirectorAstraZeneca GMD IO, Gaitherburg, MD, USA
Parker SuzanneStudy DirectorAstraZeneca RDM, South San Francisco, USA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I have stable brain or spinal metastases and haven't taken steroids for 14 days.I have or had an autoimmune or inflammatory disorder like colitis.I have not had chemotherapy or any systemic therapy for advanced NSCLC.My cancer shows high PD-L1 expression.I am 18 years old or older.My condition is Stage IV non-small cell lung cancer.My cancer does not have EGFR mutations or ALK rearrangements.My lung cancer is a mix of small-cell and non-small cell types.I have previously received immunotherapy but not cancer vaccines.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: Standard of Care
- Group 2: Arm 1: Durvalumab
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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