← Back to Search

Checkpoint Inhibitor

Durvalumab for Non-Small Cell Lung Cancer (COAST Trial)

Phase 2
Waitlist Available
Research Sponsored by MedImmune LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of randomization until disease progression or up to a maximum of 5 years
Awards & highlights

COAST Trial Summary

This trial is testing if adding a new medication to durvalumab (a cancer immunotherapy) will work better than durvalumab alone to treat patients with lung cancer that has spread and cannot be removed by surgery, and who have not gotten worse after receiving standard chemotherapy and radiation.

Eligible Conditions
  • Non-Small Cell Lung Cancer
  • Unresectable

COAST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of randomization until disease progression or up to a maximum of 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of randomization until disease progression or up to a maximum of 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response (OR) rate as a measure of antitumor activity of durvalumab alone vs durvalumab in combination with novel agents
Secondary outcome measures
Development of detectable anti-drug antibody (ADA) to durvalumab
Development of detectable anti-drug antibody (ADA) to durvalumab or novel biologic agents
Disease Control (DC) as a measure of efficacy of durvalumab alone vs durvalumab in combination with novel agents
+7 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

COAST Trial Design

3Treatment groups
Experimental Treatment
Group I: Control Arm (Durvalumab monotherapy)Experimental Treatment1 Intervention
durvalumab IV
Group II: Arm B (durvalumab + monalizumab)Experimental Treatment1 Intervention
durvalumab IV and monalizumab IV
Group III: Arm A (durvalumab + oleclumab):Experimental Treatment1 Intervention
durvalumab IV and oleclumab IV
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Durvalumab + Monalizumab
2018
Completed Phase 2
~190
Durvalumab + Oleclumab
2018
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

MedImmune LLCLead Sponsor
347 Previous Clinical Trials
793,721 Total Patients Enrolled

Frequently Asked Questions

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

What are some other ways in which Durvalumab has been tested?

"At the moment, 341 clinical trials are underway that concern Durvalumab. Out of those active studies, 52 have reached Phase 3. Although most of the research for Durvalumab is conducted in Cordoba, Texas, there are 13112 total locations running these sorts of tests."

Answered by AI

Who meets the stringent requirements to be a part of this research project?

"This study is looking for 188 patients who have lung cancer and meet the following criteria: Subjects must be aged 18-99, have at least one previously irradiated tumor lesion that can be measured by RECIST v1.1, provide a tumor tissue sample from original diagnosis (if available), have a life expectancy of 12 weeks or more, have an ECOG Performance Status of 0 or 1, and weigh 35 kg or more."

Answered by AI

Can patients over the age of 30 participate in this trial?

"According to the rules for who can participate in this experiment, the youngest person allowed is 18 and the oldest is 99."

Answered by AI

Are people still being asked to participate in this experiment?

"According to the website, this particular clinical trial is not currently looking for patients. The listing was created on December 19th, 2018 and last edited on November 8th, 2022. There are over 2300 other trials that are actively recruiting right now."

Answered by AI

What is the usual reason that doctors prescribe Durvalumab?

"Durvalumab is often used to treat stage iii non-small cell lung cancer that cannot be surgically removed. Additionally, it can be employed as a first-line treatment for metastatic ureter urothelial carcinoma or in advance directives."

Answered by AI

Is this clinical trial offered in many metropolitan areas?

"Currently, this clinical trial is taking place in 32 different locations; some cities with participating clinics include Toronto, Sacramento and Richmond. If you enroll in the study, try to choose a location that is close to minimize travel."

Answered by AI

What is the fatality rate of Durvalumab?

"Durvalumab's efficacy is unproven, however it did receive a score of 2 due to data collected in Phase 2 trials supporting its safety."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC
2018. "Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03822351.
~30 spots leftby Apr 2025
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