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Checkpoint Inhibitor
Durvalumab + Oleclumab/Monalizumab for Lung Cancer (PACIFIC-9 Trial)
Phase 3
Recruiting
Led By Fabrice Barlesi, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Provision of a tumour tissue sample obtained prior to CRT
Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until 3 months after last dose of ip
Awards & highlights
PACIFIC-9 Trial Summary
This trial is testing two different combinations of drugs to see if they are more effective than just durvalumab alone in treating non-small cell lung cancer that has spread and cannot be removed by surgery.
Who is the study for?
Adults over 18 with Stage III unresectable Non-Small Cell Lung Cancer (NSCLC) who haven't worsened after platinum-based chemoradiation. They must have normal organ function, no history of certain autoimmune diseases or other cancers within the last 5 years, and not be on immunosuppressants.Check my eligibility
What is being tested?
The study is testing Durvalumab in combination with either Oleclumab or Monalizumab against a placebo to see if they improve outcomes for NSCLC patients post-chemoradiation. It's randomized and double-blind, meaning neither doctors nor patients know who gets which treatment.See study design
What are the potential side effects?
Durvalumab can cause immune-related side effects like inflammation in various organs, skin reactions, hormone gland problems, and infusion-related symptoms. Oleclumab and Monalizumab may also trigger similar immune responses.
PACIFIC-9 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have provided a tumor tissue sample before starting CRT.
Select...
My lung cancer was confirmed by lab tests and treated with combined chemo and radiation for stage III.
Select...
I have completed at least 2 cycles of chemotherapy with platinum drugs and radiation.
Select...
I am fully active or able to carry out light work.
Select...
I received a specific dose of radiation as part of my treatment.
Select...
My cancer does not have changes in the EGFR or ALK genes.
Select...
My condition did not worsen after receiving specific chemotherapy and radiation together.
Select...
I am 18 years old or older.
PACIFIC-9 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization until 3 months after date of last ip dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until 3 months after date of last ip dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Surival (PFS)
Secondary outcome measures
Anti-drug antibodies (ADAs)
Concentration of Durvalumab
Concentration of Monalizumab
+12 moreSide 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-9 Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm B: Durvalumab and MonalizumabExperimental Treatment3 Interventions
Durvalumab + Monalizumab on Day 1 of each 28-day cycle for up to 12 months. Placebo infusion will be administered on Day 15 of cycles 1 and 2 only
Group II: Arm A: Durvalumab and OleclumabExperimental Treatment2 Interventions
Durvalumab on Day 1 of each 28-day cycle + Oleclumab on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months
Group III: Arm C: Durvalumab and PlaceboActive Control2 Interventions
Durvalumab on Day 1 of each 28-day cycle + Placebo on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Monalizumab
2019
Completed Phase 2
~250
Oleclumab
2015
Completed Phase 2
~880
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,265 Previous Clinical Trials
288,604,283 Total Patients Enrolled
Fabrice Barlesi, MDPrincipal InvestigatorGustave Roussy, Cancer Campus, Grand Paris
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung cancer is a mix of small cell and non-small cell types.I have provided a tumor tissue sample before starting CRT.My Stage III NSCLC has worsened despite platinum-based treatments.My organs and bone marrow are working well.Your tumor has been tested for PD-L1 status by a central laboratory.I don't have lasting side effects from previous cancer treatments, except for hair loss.I haven't taken immunosuppressive drugs in the last 14 days.I am getting chemoradiation for Stage III non-small cell lung cancer that can't be removed with surgery.I had cancer before, but it was either treated over 5 years ago, was a non-melanoma skin cancer, or was an early-stage tumor with no current signs of disease.I have had lung inflammation from previous cancer treatments.I have had lung issues like fibrosis or pneumonia in the past 6 months.My lung cancer was confirmed by lab tests and treated with combined chemo and radiation for stage III.I have completed at least 2 cycles of chemotherapy with platinum drugs and radiation.I am fully active or able to carry out light work.I received a specific dose of radiation as part of my treatment.I have or had an autoimmune or inflammatory disorder.My cancer does not have changes in the EGFR or ALK genes.My condition did not worsen after receiving specific chemotherapy and radiation together.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Durvalumab and Oleclumab
- Group 2: Arm C: Durvalumab and Placebo
- Group 3: Arm B: Durvalumab and Monalizumab
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.
Is this clinical trial happening in more than one state?
"Currently, there are 28 sites across the country that are enrolling patients for this trial. If you are interested in participating, please choose the clinical trial centre that is most convenient for you to help reduce travel-related expenses."
Answered by AI
Are people currently signing up to participate in this experiment?
"The listings on clinicaltrials.gov show that this study is still opening up to new patients. The original posting was on February 7th, 2022 and the most recent update was on October 11th, 2022. So far, 28 different medical centres have enrolled a total of 999 patients."
Answered by AI
What is the maximum tolerable dose of Durvalumab?
"Durvalumab has received a Phase 3 safety rating, meaning that while there is some data to support efficacy, there is also multiple rounds of safety data available."
Answered by AI
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