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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 below
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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:
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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.
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I am not taking, nor can I stop taking, drugs or supplements that strongly affect liver enzymes.
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I have received chemotherapy for my condition before or after surgery.
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I have a condition or risk that can cause long QT syndrome.
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My lung cancer is a mix of small cell and non-small cell types.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up to 7 years for reporting.

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 more
Other study objectives
Lung Cancer Mortality
Lung cancer mortality

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
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
4,388 Previous Clinical Trials
289,108,381 Total Patients Enrolled

Media Library

Durvalumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03833154 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: SoC SBRT + Osimertinib Therapy (Osimertinib cohort, single-arm, open-label separate cohort), SoC SBRT + Durvalumab Therapy (Main Cohort), SoC SBRT + Placebo Therapy (Main Cohort)
Non-Small Cell Lung Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT03833154 — Phase 3
Durvalumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03833154 — Phase 3
~216 spots leftby Apr 2027
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