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Immunotherapy for Small Cell Lung Cancer (ADRIATIC Trial)

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Received 4 cycles of chemotherapy concurrent with radiotherapy, which must be completed within 1 to 42 days prior to randomization and the first dose of IP. Chemotherapy must contain platinum and IV etoposide. Radiotherapy must be either total 60-66 Gy over 6 weeks for the standard QD regimen or total 45 Gy over 3 weeks for hyperfractionated BD schedules
Have not progressed following definitive concurrent chemoradiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6 years
Awards & highlights

ADRIATIC Trial Summary

This trial is testing if two immunotherapy drugs can help people with lung cancer who haven't gotten better after standard treatment.

Who is the study for?
This trial is for patients with limited-stage small cell lung cancer (stages I-III) who haven't worsened after chemoradiation. They must have completed a specific chemotherapy and radiotherapy regimen recently, be expected to live at least 12 weeks, and have an ECOG performance status of 0 or 1.Check my eligibility
What is being tested?
The study tests Durvalumab alone or combined with Tremelimumab versus a placebo as additional treatment post-chemoradiation in phase III trials. It's randomized, double-blind, and includes multiple international centers.See study design
What are the potential side effects?
Durvalumab and Tremelimumab can cause immune-related side effects like inflammation in various organs, fatigue, potential infections due to weakened immunity, skin reactions, hormonal changes, and infusion-related reactions.

ADRIATIC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've completed 4 cycles of specific chemo and radiotherapy recently.
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My condition has not worsened after receiving combined chemotherapy and radiation.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My lung cancer is small cell type and not spread widely (stage I-III).

ADRIATIC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 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
Progression-free survival (PFS)
Secondary outcome measures
Objective Response Rate (ORR)
Overall Survival (OS)
PD-L1 expression in tumor and/or immune cells relative to response/efficacy outcomes (PFS, OS & ORR).
+11 more
Other outcome measures
Adverse Events

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

ADRIATIC Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Durvalumab + TremelimumabExperimental Treatment2 Interventions
Durvalumab in combination with tremelimumab: Durvalumab (1500 mg IV) q4w in combination with tremelimumab (75 mg IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with tremelimumab.
Group II: Durvalumab + PlaceboExperimental Treatment2 Interventions
Durvalumab monotherapy: Durvalumab (1500 mg intravenous [IV]) q4w in combination with placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by durvalumab 1500 mg q4w. The first durvalumab monotherapy 1500 mg dose q4w will be 4 weeks after the final dose of durvalumab in combination with placebo saline solution.
Group III: Placebo + PlaceboPlacebo Group1 Intervention
Placebo: Placebo saline solution (IV) q4w in combination with a second placebo saline solution (IV) q4w for up to 4 doses/cycles each, followed by a single placebo saline solution q4w. The first placebo saline solution monotherapy dose q4w will be 4 weeks after the final dose of the 2 placebo saline solutions in combination.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Tremelimumab
2017
Completed Phase 2
~3380

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,287 Previous Clinical Trials
288,619,420 Total Patients Enrolled
Haiyi Jiang, M.D.Study DirectorAstraZeneca
2 Previous Clinical Trials
1,059 Total Patients Enrolled

Media Library

Durvalumab Clinical Trial Eligibility Overview. Trial Name: NCT03703297 — Phase 3
Small Cell Lung Cancer Research Study Groups: Durvalumab + Placebo, Durvalumab + Tremelimumab, Placebo + Placebo
Small Cell Lung Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT03703297 — Phase 3
Durvalumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT03703297 — Phase 3
~31 spots leftby Sep 2024
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