← Back to Search

Checkpoint Inhibitor

Immunotherapy Combo for Lung Cancer (PACIFIC-8 Trial)

Phase 3
Recruiting
Led By Hidehito Horinouchi, MD, PhD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
Patients must not have progressed following definitive, platinum-based, concurrent chemoradiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 12 weeks after last ip dose.
Awards & highlights

PACIFIC-8 Trial Summary

This trial is testing a new immunotherapy drug combo to see if it's more effective than just one of the drugs for treating lung cancer that has spread and can't be removed by surgery.

Who is the study for?
Adults with Stage III unresectable NSCLC who haven't progressed after platinum-based chemoradiation can join. They need a PD-L1 status ≥ 1%, adequate organ function, and no history of certain cancers or autoimmune diseases. Participants must be over 18, have completed at least two cycles of chemo with radiation, and not have used immunosuppressive drugs recently.Check my eligibility
What is being tested?
The study compares the effectiveness and safety of Durvalumab combined with Domvanalimab versus Durvalumab with a placebo in patients who've had concurrent chemoradiation therapy for lung cancer. It's randomized, double-blind, and includes multiple international centers.See study design
What are the potential side effects?
Durvalumab and Domvanalimab may cause immune-related reactions affecting organs, infusion-related symptoms like fever or chills, fatigue, possible lung inflammation (pneumonitis), skin issues, hormonal gland problems which could affect metabolism or mood.

PACIFIC-8 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung cancer was confirmed by lab tests and treated with chemo and radiation for stage III.
Select...
My condition did not worsen after receiving specific chemotherapy and radiation together.
Select...
My cancer does not have mutations in the EGFR or ALK genes.
Select...
I have completed at least 2 cycles of chemotherapy with platinum drugs and radiation.
Select...
My organs and bone marrow are working well.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My tumor's PD-L1 status is 1% or higher.
Select...
I am 18 years old or older.
Select...
I received a specific dose of radiation as part of my treatment.
Select...
I have provided a tumor tissue sample before starting CRT.

PACIFIC-8 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 12 weeks after last ip dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 weeks after last ip dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Anti-Drug Antibodies (ADAs)
Concentration of Durvalumab and Domvanalimab
Duration of Response (DoR)
+8 more

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%
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-8 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: Durvalumab + DomvanalimabExperimental Treatment2 Interventions
Durvalumab and domvanalimab as an IV infusion q4w, starting on Day 1 for up to a maximum of 12 months
Group II: Arm B: Durvalumab + PlaceboActive Control2 Interventions
Durvalumab + placebo as an IV infusion q4w starting on Day 1 for up to a maximum of 12 months
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?

Arcus Biosciences, Inc.Industry Sponsor
41 Previous Clinical Trials
5,206 Total Patients Enrolled
AstraZenecaLead Sponsor
4,257 Previous Clinical Trials
288,592,926 Total Patients Enrolled
Hidehito Horinouchi, MD, PhDPrincipal InvestigatorNational Cancer Center Hospital

Media Library

Domvanalimab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05211895 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Arm A: Durvalumab + Domvanalimab, Arm B: Durvalumab + Placebo
Non-Small Cell Lung Cancer Clinical Trial 2023: Domvanalimab Highlights & Side Effects. Trial Name: NCT05211895 — Phase 3
Domvanalimab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05211895 — Phase 3

Frequently Asked Questions

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

Are researchers still looking for participants in this trial?

"This is an active clinical trial that is currently recruiting patients. The trial was first posted on February 18, 2022, and was last updated on October 26, 2022."

Answered by AI

What is the legal status of Durvalumab in the United States?

"There is both pre-existing clinical evidence and multiple rounds of supportive data that suggest Durvalumab is safe, thus it received a score of 3."

Answered by AI

On how many different continents is this scientific research being conducted?

"26 research centres are running this study at the moment. They are situated in Washington, Nashville, Berkeley Heights and also 26 other places. If you want to take part in this trial, it would be helpful to choose the research clinic which is closest to you to reduce travel time."

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
Recent research and studies
clinicaltrials.govStudy
A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC
2022. "A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05211895.
All > Lung Cancer Cincinnati
~566 spots leftby Jun 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top