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Durvalumab for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
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 8 weeks ±1 week after ip treatment initiation and continue q8w ±1 week through 52 weeks and q12w ±1 week until disease progression (approximately upto 27 months)
Awards & highlights

Study Summary

This trial is testing a new drug to treat lung cancer that has not responded to other treatments. The side effects of the drug will be monitored.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 8 weeks ±1 week after investigational product (ip) treatment initiation and continue every 8 weeks (q8w) ±1 week through 52 weeks and every 12 weeks (q12w) ±1 week until disease progression (approximately upto 27 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 8 weeks ±1 week after investigational product (ip) treatment initiation and continue every 8 weeks (q8w) ±1 week through 52 weeks and every 12 weeks (q12w) ±1 week until disease progression (approximately upto 27 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Grade 3 and Grade 4 Treatment-related Adverse Events (TRAEs)
Secondary outcome measures
Duration of Response (DOR) From Onset of Response
Malignant Neoplasms
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Event of Special Interests (AESIs), and Immune-mediated Adverse Event (imAEs)
+5 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

Trial Design

2Treatment groups
Experimental Treatment
Group I: WHO/ECOG PS 2 CohortExperimental Treatment1 Intervention
up to 30 participants will receive 1500 mg Durvalumab (MEDI4736) monotherapy via IV infusion q4w for up to a maximum of 24 months (up to 26 doses/cycles) with the last administration at Week 104. The study drug should be discontinued prior to 24 months if there is clinical progression or confirmed radiological progression or if there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
Group II: WHO/ECOG PS 0 to 1 CohortExperimental Treatment1 Intervention
100-120 participants will receive 1500 mg Durvalumab (MEDI4736) monotherapy via IV infusion q4w for up to a maximum of 24 months (up to 26 doses/cycles) with the last administration at Week 104. The study drug should be discontinued prior to 24 months if there is clinical progression or confirmed radiological progression or if there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
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?

AstraZenecaLead Sponsor
4,251 Previous Clinical Trials
288,537,184 Total Patients Enrolled

Frequently Asked Questions

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

Does this research project welcome people who are over 30 years old?

"The age range for patients that are eligible for this trial is 18-130 years old."

Answered by AI

What other research studies have included Durvalumab as a treatment?

"Durvalumab is being researched in 338 different clinical trials, 51 of which are in the third and final stage. The majority of these studies are located in Cordoba, Texas; however, there are 12904 total research sites for this medication."

Answered by AI

What types of cancer does Durvalumab commonly target?

"Durvalumab can improve the prognosis for patients with unresectable stage iii non-small cell lung cancer, metastatic ureter urothelial carcinoma, and other advanced directives."

Answered by AI

How many people are being monitored in this experiment?

"Presently, this particular trial is not looking for new participants. The 11/4/2022 update marks the end of the most recent recruiting drive. If you're interested in other studies, there are 1963 trials actively searching for patients with carcinoma and 338 studies for Durvalumab that are still recruiting patients."

Answered by AI

Are there any dangers to using Durvalumab?

"Given that this is a Phase 2 trial, meaning that while there is some data supporting safety, there is no efficacy data currently available, our team has rated the Durvalumab as a 2."

Answered by AI

Are new participants currently being sought for this trial?

"This particular clinical trial is not currently recruiting, as stated on the government-run website dedicated to this sort of information. The listing for this trial was created on April 16th, 2019 and was last updated November 4th, 2022. There are 2301 other trials that are actively seeking participants right now."

Answered by AI

What are the medical team's goals for this clinical trial?

"The primary goal for this clinical trial, which will last up to 6 months, is to monitor the number of patients that experience grade 3 or 4 treatment-related adverse events. Additionally, secondary outcomes include observing the number of patients that have adverse events, serious adverse events, immune-mediated adverse events, and Adverse event of special interests. To assess the safety and tolerability profile of Durvalumab(MEDI4736), Overall Survival and Lung cancer Mortality will also be monitored."

Answered by AI

Might I be a good candidate for this research project?

"This study is seeking 117 individuals that currently have non-small-cell lung carcinoma. These patients must also meet the following requirements: Be between 18 and 130 years old, provide a signed informed consent form before any procedures specific to this trial, receive two or more cycles of platinum-based chemotherapy before radiation therapy (with no more than 6 weeks in between the last dose of chemotherapy and start of radiation), not receive consolidation chemotherapy after radiation therapy unless specified in bullet point 6(b), have a platinum-based chemotherapy regimen that contains cisplatin or carboplatin as well as one of the following agents: etoposide, v"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Determine Safety of Durvalumab After Sequential Chemo Radiation in Patients With Unresectable Stage III Non-Small Cell Lung Cancer
2019. "A Study to Determine Safety of Durvalumab After Sequential Chemo Radiation in Patients With Unresectable Stage III Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03693300.
~19 spots leftby Apr 2025
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