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Checkpoint Inhibitor
Durvalumab/Osimertinib + SBRT for Lung Cancer (PACIFIC-4 Trial)
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
WHO/ECOG PS of 0, 1 or 2
Age ≥18 years
Must not have
Prior treatment with neoadjuvant or adjuvant EGFR TKI
Patients currently receiving potent inducers of CYP3A4
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up to 7 years
Awards & highlights
Pivotal Trial
Summary
This trial is testing a new cancer treatment (durvalumab with SoC SBRT) against the current best treatment (placebo with SoC SBRT) for early stage non-small cell lung cancer.
Who is the study for?
This trial is for adults over 18 with early-stage, unresected non-small cell lung cancer without lymph node involvement. Participants must weigh more than 30 kg and have good organ function. Those with certain EGFR mutations can join an additional cohort. Contraception is required during the study.
What is being tested?
The trial tests if durvalumab combined with standard-of-care stereotactic body radiation therapy (SBRT) improves outcomes compared to placebo plus SBRT in one group, while another group receives osimertinib following SBRT if they have specific EGFR mutations.
What are the potential side effects?
Durvalumab may cause immune-related side effects like inflammation of organs, fatigue, and infusion reactions. Osimertinib could lead to diarrhea, rash, dry skin, nail changes, mouth sores and might affect heart rhythm or liver enzymes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
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I am 18 years old or older.
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My tumor has EGFR mutations linked to treatment response.
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My body weight is over 30 kg.
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I can provide a sample of my tumor tissue.
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I can take care of myself but may not be able to do heavy physical work.
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I am scheduled for targeted radiation therapy as my main cancer treatment.
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My organs and bone marrow are working well.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have previously received EGFR TKI therapy before or after surgery.
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I am currently taking medication that strongly activates CYP3A4.
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I have had lung inflammation or damage that needed steroids.
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I cannot take osimertinib due to severe nausea, vomiting, gut diseases, swallowing issues, or major bowel surgery.
Select...
I am not taking, nor can I stop taking, drugs or supplements that strongly affect liver enzymes.
Select...
I have received chemotherapy for my condition before or after surgery.
Select...
I have a condition or risk that can cause long QT syndrome.
Select...
My lung cancer is a mix of small cell and non-small cell types.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization up to 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to 7 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
4-year Progression-Free Survival (4y-PFS) by ICR according to RECIST 1.1 criteria
Progression-Free Survival (PFS) assessed by Blinded Independent Central Review (BICR) according to RECIST 1.1 in subpopulation of patients with Stage I/II NSCLC
Secondary study objectives
Assessment of AEs by CTCAE v 5.0 as measures of the safety and tolerability of Durvalumab with SoC SBRT compared to placebo with SoC SBRT
Assessment of AEs by CTCAE v 5.0 as measures of the safety, tolerability and compliance of osimertinib with SoC SBRT therapy
Concentration of durvalumab in serum such as peak concentration and trough
+16 moreOther study objectives
Lung Cancer Mortality
Lung cancer mortality
Side effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Anorexia
30%
Constipation
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Cough
15%
Abdominal Pain
15%
Back pain
15%
Increased Urinary Frequency
15%
Weight gain
13%
Arthralgia
10%
Dizziness
10%
Anxiety
10%
Bladder infection
10%
Nasal congestion
10%
Vaginal discharge
8%
Colitis
8%
Dry mouth
8%
Dry skin
8%
Fever
8%
Anal pain
8%
Edema limbs
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Small intestinal obstruction
8%
Thromboembolic event
8%
Urinary frequency
8%
Urinary tract pain
5%
Confusion
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Anemia
5%
Ascites
5%
Gastroesophageal reflux disease
5%
Hypomagnesemia
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Rash acneiform
5%
Sinus bradycardia
5%
Upper respiratory infection
5%
Urinary urgency
5%
Vaginal hemorrhage
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Colonic perforation
3%
Dysarthria
3%
Blood bilirubin increased
3%
CPK increased
3%
Creatinine increased
3%
Myositis
3%
Rectal hemorrhage
3%
Hypothyroidism
3%
Left ventricular systolic dysfunction
3%
Lethargy
3%
Muscle weakness left-sided
3%
Myocarditis
3%
Rectal pain
3%
Weight Loss
3%
Fall
3%
Generalized muscle weakness
3%
Hyperglycemia
3%
Hyperkalemia
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Pleural effusion
3%
Skin infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: SoC SBRT + Osimertinib Therapy (Osimertinib cohort, single-arm, open-label separate cohort)Experimental Treatment1 Intervention
SBRT
Osimertinib 80mg every day \[qd\] for oral administration up to 36 months or until progression. Osimertinib treatment should start within 7 to 14 days after completion of SBRT
Group II: SoC SBRT + Durvalumab Therapy (Main Cohort)Experimental Treatment1 Intervention
SBRT
Durvalumab (PD-L1 monoclonal antibody) 1500 mg every 4 weeks \[q4w\] intravenously \[iv\] for up to 26 cycles or until progression or other discontinuation criteria are met.
Group III: SoC SBRT + Placebo Therapy (Main Cohort)Placebo Group1 Intervention
SBRT
Placebo (matching placebo for infusion) every 4 weeks iv for up to 26 cycles or until progression or other discontinuation criteria are met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3750
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,163,887 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's electrical activity is too slow, as shown by multiple ECG tests.I have previously received EGFR TKI therapy before or after surgery.I can take care of myself and perform daily activities.I have had lung cancer more than once or at the same time, with some exceptions.My cancer does not have the EGFR mutation according to tests.I am currently taking medication that strongly activates CYP3A4.You are expected to live for at least 12 more weeks.I am 18 years old or older.I have had a PET-CT scan within the last 10 weeks.My cancer involves central or peripheral lesions.You have a history of an ongoing immune system problem from birth.My tumor has EGFR mutations linked to treatment response.I have had lung inflammation or damage that needed steroids.You have had an organ transplant from another person.I have been treated with immunotherapy before, with some exceptions.Your resting ECG shows important abnormalities in your heart's rhythm, conduction, or shape.My body weight is over 30 kg.I will use condoms during the trial to prevent pregnancy.I can provide a sample of my tumor tissue.I can take care of myself but may not be able to do heavy physical work.I have had another type of cancer before.I am scheduled for targeted radiation therapy as my main cancer treatment.I cannot take osimertinib due to severe nausea, vomiting, gut diseases, swallowing issues, or major bowel surgery.I am not taking, nor can I stop taking, drugs or supplements that strongly affect liver enzymes.My organs and bone marrow are functioning well.I have received chemotherapy for my condition before or after surgery.I have a condition or risk that can cause long QT syndrome.You need to provide a sample of your tumor tissue if you have one.My organs and bone marrow are working well.My lung cancer is a mix of small cell and non-small cell types.I don't have a family history of sudden death before 40 or take medications that affect my heart rhythm.
Research Study Groups:
This trial has the following groups:- Group 1: SoC SBRT + Osimertinib Therapy (Osimertinib cohort, single-arm, open-label separate cohort)
- Group 2: SoC SBRT + Durvalumab Therapy (Main Cohort)
- Group 3: SoC SBRT + Placebo Therapy (Main Cohort)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.