Your session is about to expire
← Back to Search
Alkylating agents
Durvalumab + Chemotherapy for Small Cell Lung Cancer (LUMINANCE 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
No prior exposure to immune-mediated therapy including, but not limited to, other anti- CTLA-4, anti-Programmed cell death-1 (PD-1), anti- Programmed cell death ligand-1 (PD-L1), and anti-PD-L2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines
Participants must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for the ES-SCLC. Chemotherapy must contain either cisplatin or carboplatin in combination with etoposide
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until disease progression (approximately upto 1.6 years)
Awards & highlights
LUMINANCE Trial Summary
This trial will study the safety and side effects of using durvalumab with platinum and etoposide to treat extensive-stage small-cell lung cancer.
Who is the study for?
This trial is for adults with extensive-stage small cell lung cancer who haven't had treatment before. They should be in good physical condition, have proper organ function, and weigh over 30 kg. Women must not be pregnant and participants must agree to use birth control. People can't join if they've had certain vaccines recently, previous cancer treatments for SCLC, or are on immunosuppressants.Check my eligibility
What is being tested?
The study tests the safety of Durvalumab combined with platinum (either Cisplatin or Carboplatin) plus Etoposide as a first-line treatment for patients with extensive-stage small cell lung cancer. It aims to see how well patients tolerate this combination therapy.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that could affect organs, infusion-related symptoms like fever or chills, fatigue, nausea or vomiting from chemotherapy drugs, blood count changes increasing infection risk and potential allergic reactions to any of the drugs used.
LUMINANCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not been treated with immune therapy drugs before.
Select...
I am eligible for a first-time chemotherapy that includes platinum for my small cell lung cancer.
Select...
My small cell lung cancer is confirmed by tests and is at an advanced stage.
Select...
I am post-menopausal or not currently pregnant.
Select...
My body weight is over 30 kg.
LUMINANCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until disease progression (approximately upto 1.6 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until disease progression (approximately upto 1.6 years)
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 incidence of Grade 3 and higher adverse events (AEs)
Number of participants with incidence of Immune mediated adverse events (imAEs)
Secondary outcome measures
Duration of response (DoR)
Number of participants with adverse events and serious adverse events
Number of participants with adverse events of special interests
+6 moreSide effects data
From 2022 Phase 2 trial • 80 Patients • NCT0301512965%
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
LUMINANCE Trial Design
1Treatment groups
Experimental Treatment
Group I: Durvalumab - (cisplatin or carboplatin) - EtoposideExperimental Treatment4 Interventions
Participants will receive durvalumab dose A administered via intravenous (IV) infusion concurrently with platinum-based chemotherapy and etoposide every 3 weeks (q3w). Thereafter, durvalumab monotherapy will be continued every 4 weeks post-chemotherapy unless specific treatment discontinuation criteria are met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670
Etoposide
2010
Completed Phase 3
~2440
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,750 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been treated with immune therapy drugs before.I am eligible for a first-time chemotherapy that includes platinum for my small cell lung cancer.I have had treatment for small cell lung cancer that has spread.My small cell lung cancer is confirmed by tests and is at an advanced stage.I do not have active infections like TB, hepatitis B, C, or HIV.I can perform daily activities and have had recent scans of my brain, chest, and abdomen.I have or had lupus, sarcoidosis, or wegener syndrome.I don't have lasting side effects from cancer treatment worse than Grade 2.I have had cancer before, but it was either treated over 5 years ago, was a non-melanoma skin cancer, or was a carcinoma in situ, and I currently have no signs of disease.I am post-menopausal or not currently pregnant.My organs and bone marrow are working well.My body weight is over 30 kg.I am not pregnant or breastfeeding and agree to use birth control during and after the trial.I do not have any serious ongoing illnesses that could affect my participation in the study.I am scheduled for chest radiation therapy but any other radiation for symptom relief will be completed before starting the study medication.I have not received a live vaccine in the last 30 days.I have not had major surgery in the last 28 days.I haven't taken immunosuppressive drugs in the last 14 days.I have previously received immunotherapy treatments.I cannot receive platinum-etoposide chemotherapy due to health reasons.You have received an organ from another person in the past.I am not on any cancer treatments but can take hormones for other conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Durvalumab - (cisplatin or carboplatin) - Etoposide
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the main conditions that Durvalumab is approved to target?
"Durvalumab is an effective treatment for hodgkin disease, malignant pleural mesothelioma, and advanced head and neck cancer."
Answered by AI
Who does this research study require as participants?
"This study is only seeking patients that have small cell lung carcinoma and are between 18-130 years old, for a total of 150 participants."
Answered by AI
What are some of the side effects that people have reported from using Durvalumab?
"Durvalumab has been studied in multiple Phase 3 trials, so there is some data supporting its efficacy and safety. Our team at Power rates it as a 3 on a scale of 1 to 3."
Answered by AI
What other research has been done using Durvalumab?
"As of now, 1581 studies are running that investigate Durvalumab. 454 of those are Phase 3 clinical trials. Most of the research for Durvalumab is conducted in Shanghai, but there are 78980 locations worldwide where Durvalumab trials are taking place."
Answered by AI
How many patients are qualified to enroll in this clinical trial?
"That is accurate, the listing on clinicaltrials.gov reveals that the trial is ongoing and actively recruitment patients. The trial was first posted on November 11th, 2021 and was last updated on October 13th, 2022. They are looking for a total of 150 participants that will be spread out across 3 hospitals."
Answered by AI
Does this research project involve testing with volunteers who are over 35 years old?
"This trial is only open to individuals aged 18 or above, and 130 or below."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger