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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
Must not have
Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab
Active EBV infection, or known or suspected chronic active EBV infection at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 12 weeks after last ip dose.
Awards & highlights
Pivotal 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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't taken immunosuppressive drugs in the last 14 days.
Select...
I have an active Epstein-Barr virus infection.
Select...
I am getting chemoradiation for Stage III non-small cell lung cancer that can't be removed by surgery.
Select...
My lung cancer is a mix of small cell and non-small cell types.
Select...
I have or had lung conditions like fibrosis or pneumonia not caused by cancer treatment.
Select...
My Stage III NSCLC worsened despite platinum-based treatments.
Select...
I don't have lasting side effects worse than Grade 2 from previous treatments, except for hair loss.
Select...
I have lung inflammation from previous cancer treatments.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
Anti-Drug Antibodies (ADAs)
Concentration of Durvalumab and Domvanalimab
Duration of Response (DoR)
+9 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%
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

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
~3750

Find a Location

Who is running the clinical trial?

Arcus Biosciences, Inc.Industry Sponsor
43 Previous Clinical Trials
6,332 Total Patients Enrolled
AstraZenecaLead Sponsor
4,425 Previous Clinical Trials
289,140,084 Total Patients Enrolled
Hidehito Horinouchi, MD, PhDPrincipal InvestigatorNational Cancer Center Hospital
Alexander Spira, MD, PhDPrincipal InvestigatorVirginia Cancer Specialists Research Institute
1 Previous Clinical Trials
96 Total Patients Enrolled
Jinming Yu, MD, PhDPrincipal InvestigatorShandong Cancer Hospital and Institute
1 Previous Clinical Trials
500 Total Patients Enrolled

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
~475 spots leftby Jun 2028
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