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Chemotherapy

Durvalumab for Lung Cancer

Phase 2
Waitlist Available
Led By Ramesh Rengan
Research Sponsored by University of Washington
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 study enrollment to disease progression or death, whichever occurs first, for up to 1 year
Awards & highlights

Study Summary

This trial is studying whether adding the drug Durvalumab earlier in treatment and intensifying treatment with durvalumab can improve cancer control and decrease side effects.

Eligible Conditions
  • Lung Cancer
  • Lung Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study enrollment to disease progression or death, whichever occurs first, for up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and study enrollment to disease progression or death, whichever occurs first, for up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1 Year Progression-free Survival Rate (PFS)
Secondary outcome measures
Frequency and Severity of Pneumonitis
Frequency of Adverse Events
Overall Survival (OS)
+1 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

1Treatment groups
Experimental Treatment
Group I: Treatment (chemotherapy, durvalumab, radiation therapy)Experimental Treatment5 Interventions
Patients with squamous cell cancer receive standard of care chemotherapy consisting of cisplatin on days 1, 8, 29, and 36, and etoposide on days 1-5 and 29-33. Cycles repeat every 4 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with non-squamous cell cancer receive standard of care chemotherapy consisting of cisplatin and pemetrexed on days 1, 22, and 43. Cycles repeat every 3 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. All patients receive durvalumab IV over 1 hour Q4W. Radiation to the primary tumor will be given over 8-15 fractions during weeks 1-3 of chemotherapy. For patients who have residual disease in the mediastinal lymph nodes at week 9, radiation will be given to the lymph nodes starting week 11. Durvalumab is given for 2 years after completion of radiation in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etoposide
2010
Completed Phase 3
~2440
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~130
Pemetrexed
2014
Completed Phase 3
~5250
Cisplatin
2013
Completed Phase 3
~1940
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
4,253 Previous Clinical Trials
288,537,747 Total Patients Enrolled
University of WashingtonLead Sponsor
1,737 Previous Clinical Trials
1,843,460 Total Patients Enrolled
Ramesh RenganPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
2 Previous Clinical Trials
44 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
ADMIRAL Trial: Adaptive Mediastinal Radiation With Chemo-Immunotherapy
Jing Zeng 2021. "ADMIRAL Trial: Adaptive Mediastinal Radiation With Chemo-Immunotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04372927.
~0 spots leftby Apr 2025
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