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Immunotherapy for Small Cell Lung Cancer (ADRIATIC Trial)

Q: What is the primary indication for Durvalumab?

<p>Durvalumab is a medication frequently used to treat non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a> that cannot be removed surgically. It can also help patients suffering from ureter urothelial carcinoma metastasis or those with advance directives.</p>

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 will have brain radiation after my initial cancer treatment, within 1 to 42 days before starting the trial medication.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 6 years

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

Edema limbs

Fever

Anal pain

Dry skin

Colitis

Thromboembolic event

Dry mouth

Flatulence

Headache

Hot flashes

Myalgia

Urinary tract pain

Urinary frequency

Small intestinal obstruction

Anemia

Ascites

Confusion

Pneumonitis

Sinus bradycardia

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Memory impairment

Vaginal hemorrhage

Hypomagnesemia

Upper respiratory infection

Mucositis oral

Rash acneiform

Urinary urgency

Gastroesophageal reflux disease

Lymphedema

Rectal hemorrhage

Colonic perforation

Generalized muscle weakness

Hyperkalemia

Lethargy

Myocarditis

Fall

Skin infection

Hypothyroidism

Muscle weakness left-sided

Alanine aminotransferase increased

Hyperglycemia

Pleural effusion

Creatinine increased

Rectal pain

Aspartate aminotransferase increased

Dysarthria

Myositis

CPK increased

Pain in extremity

Peripheral sensory neuropathy

Alkaline phosphatase increased

Blood bilirubin increased

Left ventricular systolic dysfunction

Weight Loss

100%

80%

60%

40%

20%

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor

4,261 Previous Clinical Trials

288,593,446 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

Frequently Asked Questions

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

What are some similar investigations to the one involving Durvalumab?

"345 studies are currently underway to explore Durvalumab's efficacy. Of these, 51 clinical trials are in Phase 3. The largest concentration of research is based in Cordoba, Texas; however, there are over 13000 other locations running similar investigations."

Answered by AI

What is the primary indication for Durvalumab?

"Durvalumab is a medication frequently used to treat non-small cell lung cancer that cannot be removed surgically. It can also help patients suffering from ureter urothelial carcinoma metastasis or those with advance directives."

Answered by AI

Has this kind of clinical trial been done before?

"AstraZeneca's Durvalumab drug has been studied 37 times since 2007, with the most recent trials happening in 1325 cities across 58 countries. The very first Phase 2 trial had 37 participants and completed its approval stage that same year."

Answered by AI

Does this research allow for middle-aged participants?

"The lower bound age for this clinical trial is 18 years old, while the older limit is 130."

Answered by AI

Are there different hospitals testing this treatment in our state?

"To make things more convenient for participants, this trial is running at 39 sites. Some of these locations include Toronto, Fort Wayne and Clovis. You can choose the location nearest you when enrolling to cut down on travel time."

Answered by AI

What is the regulatory decision on Durvalumab?

"There is both pre-existing clinical data to support the efficacy of Durvalumab as well as multiple rounds of safety testing, so it received a score of 3."

Answered by AI

How many individuals are being treated as part of this experiment?

"This specific study has finished recruiting patients. According to the information on clinicaltrials.gov, this trial was first posted on September 27th 2018 and was most recently updated on September 9th 2020. However, there are presently 1615 clinical trials actively looking for patients with lung cancer and 345 studies for Durvalumab actively recruiting patients."

Answered by AI

Is this research still recruiting people who want to participate?

"Unfortunately, this trial is no longer seeking new patients. It was initially posted on September 27th, 2018 and had its last update on September 9th, 2022. If you are looking for other studies to participate in, there are currently 1615 trials actively enrolling patients with lung cancer and 345 trials for Durvalumab that need participants."

Answered by AI

How can I get involved with this research project?

"Researchers are looking for 730 individuals with lung cancer who also meet the following conditions: between 18-130 years old, completed 4 cycles of chemotherapy that included platinum and IV etoposide concurrently with radiotherapy 1-42 days before receiving the first dose of IP, have not progressed following definitive concurrent chemoradiation, have a life expectancy of at least 12 weeks, and an ECOG score of 0 or 1."

Answered by AI