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Checkpoint Inhibitor
Durvalumab/Osimertinib + SBRT for Lung Cancer (PACIFIC-4 Trial)
Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up to 7 years
Awards & highlights
PACIFIC-4 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.Check my eligibility
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.See study design
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.
PACIFIC-4 Trial 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.
PACIFIC-4 Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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
Detection of ADA neutralising antibodies titers
+17 moreOther outcome measures
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%
Constipation
30%
Anorexia
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Dyspnea
20%
Urinary tract infection
18%
Rash maculo-papular
15%
Back pain
15%
Cough
15%
Abdominal Pain
15%
Weight gain
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Anxiety
10%
Bladder infection
10%
Dizziness
10%
Nasal congestion
10%
Vaginal discharge
8%
Edema limbs
8%
Fever
8%
Anal pain
8%
Dry skin
8%
Colitis
8%
Thromboembolic event
8%
Dry mouth
8%
Flatulence
8%
Headache
8%
Hot flashes
8%
Myalgia
8%
Urinary tract pain
8%
Urinary frequency
8%
Small intestinal obstruction
5%
Anemia
5%
Ascites
5%
Confusion
5%
Pneumonitis
5%
Sinus bradycardia
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Memory impairment
5%
Vaginal hemorrhage
5%
Hypomagnesemia
5%
Upper respiratory infection
5%
Mucositis oral
5%
Rash acneiform
5%
Urinary urgency
5%
Gastroesophageal reflux disease
5%
Lymphedema
3%
Rectal hemorrhage
3%
Colonic perforation
3%
Generalized muscle weakness
3%
Hyperkalemia
3%
Lethargy
3%
Myocarditis
3%
Fall
3%
Skin infection
3%
Hypothyroidism
3%
Muscle weakness left-sided
3%
Alanine aminotransferase increased
3%
Hyperglycemia
3%
Pleural effusion
3%
Creatinine increased
3%
Rectal pain
3%
Aspartate aminotransferase increased
3%
Dysarthria
3%
Myositis
3%
CPK increased
3%
Pain in extremity
3%
Peripheral sensory neuropathy
3%
Alkaline phosphatase increased
3%
Blood bilirubin increased
3%
Left ventricular systolic dysfunction
3%
Weight Loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab
PACIFIC-4 Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: SoC SBRT + Osimertinib Therapy (Osimertinib cohort, single-arm, 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 24 months 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 24 months 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
~3870
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,606,291 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, 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can I sign up for the opportunity to be a test subject in this experiment?
"Carcinoma patients that have been diagnosed with non-small-cell lung cancer and are between 18 and 130 years old may be eligible for this study. There is space for 733 participants in total."
Answered by AI
What type of cancer does SBRT usually target?
"SBRT is most often used to treat unresectable stage iii non-small cell lung cancer; however, it can also be used as a treatment for metastatic ureter urothelial carcinoma and other conditions."
Answered by AI
How many people total are enrolled in this clinical trial?
"Yes, the clinical trial is recruiting patients as of right now. The original posting date was March 6th, 2019 and the most recent update was on September 30th, 2022. They are looking for 733 total patients with 80 different enrolment locations."
Answered by AI
What have been documented as potential side effects of SBRT?
"SBRT has received a score of 3 from our team at Power. This means that, while Phase 3 trials have not yet been completed, initial data suggests both efficacy and safety."
Answered by AI
Are individuals who are over 25 years old being sought out for this research project?
"Eligible patients for this clinical trial must be over 18 years old but not yet 130."
Answered by AI
Are people still being accepted into the trial?
"Yes, this is an active clinical trial that has edited their recruitment information most recently on 9/30/2022. They are looking for 733 participants total at 80 different locations."
Answered by AI
Are there a lot of hospitals doing this research in Canada?
"This study is looking for participants from a total of 80 sites. The locations are based in Towson, Boston and Mount Clemens as well as other places. If you want to participate, try to select the location closest you to reduce travel time requirements."
Answered by AI
Does prior research exist on the efficacy of SBRT?
"338 different ongoing studies are investigating SBRT. Out of these, 51 have reached Phase 3 clinical trials. The majority of these research programs for SBRT are based in Cordoba, Texas; however, there 12904 locations conducting trial runs for this procedure."
Answered by AI
Who else is applying?
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
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