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PD-L1 Inhibitor
Triple Drug Therapy for Non-Small Cell Lung Cancer
Phase 1 & 2
Waitlist Available
Led By Don L Gibbons
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Total body weight > 30 kg
Have adequate renal function, with a glomerular filtration rate (GFR) of >= 50 ml/min by the Cockcroft-Gault formula or by 24 hour urine collection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is testing a combination of three drugs to treat lung cancer. The first two drugs are immunotherapy drugs that help the body's immune system attack the cancer. The third drug is a drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who is the study for?
This trial is for adults with stage IV non-small cell lung cancer or recurrent disease not suitable for curative therapy. Participants must have adequate organ function, measurable disease, no prior treatment with certain inhibitors, and agree to use contraception. Those with stable brain metastases treated without steroids may qualify.Check my eligibility
What is being tested?
The study tests the combination of selumetinib (blocks tumor growth enzymes) with durvalumab and tremelimumab (monoclonal antibodies that boost the immune system against cancer). It aims to determine the best dose of selumetinib and assess how well this trio works together in advanced lung cancer.See study design
What are the potential side effects?
Potential side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, digestive issues like diarrhea or nausea, blood abnormalities such as low counts leading to increased infection risk. Specific side effects from selumetinib could involve vision changes or heart rhythm disturbances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh more than 30 kilograms.
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My kidneys work well, with a filtration rate of at least 50 ml/min.
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My lung cancer cannot be cured with surgery or radiation.
Select...
My cancer can be biopsied, and I am willing to have one.
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My kidneys are functioning well enough to filter waste.
Select...
My cancer's KRAS mutation status has been tested.
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My cancer has worsened after treatment.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) (dose-escalation phase)
Progression free survival time (PFS) (dose expansion phase)
Secondary outcome measures
Disease control rate (complete response + partial response + stable disease)
Incidence of adverse events
Overall survival (OS)
+1 moreSide effects data
From 2012 Phase 2 trial • 37 Patients • NCT0108521475%
Diarrhea
50%
Fatigue
47%
Anemia
47%
Rash acneiform
44%
Hypoalbuminemia
44%
Edema, limbs
39%
Aspartate aminotransferase increased
33%
Neutrophil count decreased
33%
White blood cell decreased
31%
Nausea
31%
Vomiting
28%
Platelet count decreased
25%
CPK increased
25%
Hypomagnesemia
22%
Hypertension
19%
Hypophosphatemia
19%
Hypocalcemia
19%
Hyponatremia
19%
Edema, face
17%
Dry skin
17%
Alanine aminotransferase increased
14%
Skin and subcutaneous tissue disorders - Other
14%
Hypokalemia
14%
Creatinine increased
14%
Back pain
14%
Dyspnea
14%
Lymphocyte count decreased
11%
Pain
11%
Fever
11%
Localized edema
11%
Peripheral sensory neuropathy
11%
Hyperkalemia
11%
Dizziness
11%
Abdominal pain
8%
Acute kidney injury
8%
Hypoglycemia
8%
Anorexia
8%
Death, NOS
8%
Periorbital edema
8%
Skin hypopigmentation
8%
Pain in extremity
8%
Cough
8%
Insomnia
8%
Alkaline phosphatase increased
8%
Dry mouth
8%
Sepsis
6%
Renal and urinary disorders - Other
6%
Dehydration
6%
Musculoskeletal and connective tissue disorder - Other, Rhabdomyolysis
6%
Hypernatremia
6%
Blood and lymphatic system disorders - Other
6%
Hypercalcemia
6%
Metabolism and nutrition disorders - Other
6%
Chills
6%
Hypotension
6%
Myalgia
6%
Arthralgia
6%
Upper respiratory infection
6%
Headache
6%
Sinusitis
6%
Generalized muscle weakness
6%
Gastrointestinal disorders - Other
6%
Gastroesophageal reflux disease
3%
Confusion
3%
Vaginal inflammation
3%
Pruritus
3%
Febrile neutropenia
3%
Flu like symptoms
3%
Hepatic failure
3%
Skin infection
3%
Fall
3%
Fracture
3%
Skin and subcutaneous tissue disorders - Other, Angular cheilitis, unilateral
3%
Adult respiratory distress syndrome
3%
Renal and urinary disorders - Other, Acute renal failure
3%
INR increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
AZD6244 (Selumetinib) Treatment
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (continuous selumetinib, durvalumab, tremelimumab)Experimental Treatment3 Interventions
Participants receive selumetinib PO BID on days 1-28 and durvalumab IV over 60 minutes on day 1. Participants also receive tremelimumab IV over 60 minutes on day 1 for courses 1-4. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (intermittent selumetinib, durvalumab, tremelimumab)Experimental Treatment3 Interventions
Participants receive selumetinib PO BID on days 1-7 and 15-21 and durvalumab intravenously (IV) over 60 minutes on day 1. Participants also receive tremelimumab IV over 60 minutes on day 1 for courses 1-4. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selumetinib
2010
Completed Phase 2
~2050
Tremelimumab
2017
Completed Phase 2
~3380
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,762 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,627 Total Patients Enrolled
Don L GibbonsPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had major surgery in the last 4 weeks, except for a procedure to get a vascular access port.I haven't taken strong immune system suppressing drugs in the last 14 days, except for low-dose or inhaled steroids.I have an autoimmune or inflammatory condition but it's controlled or I've been stable for the last 5 years.My brain or spinal metastases have been stable for 4 weeks without steroids or seizure meds.You have a history of a weakened immune system from birth.I have had an organ transplant and take medicine to lower my immune response.I have severe nausea, vomiting, or gut issues that affect medication absorption.My weight is 30 kg or less.You have a disease that can be measured using a specific set of guidelines called RECIST 1.1.I weigh more than 30 kilograms.I do not have any serious ongoing illnesses that would affect my participation in the study.I haven't had cancer treatment in the last 4-6 weeks.You must have at least 100,000 platelets per microliter of blood.Your hemoglobin level must be 9.0 grams per deciliter or higher.Your bilirubin level is not too high, unless you have a condition called Gilbert's disease.My kidneys work well, with a filtration rate of at least 50 ml/min.I don't have lasting side effects from cancer treatment, except for hair loss.I am not allergic to selumetinib, durvalumab, tremelimumab, or similar medications.I have had eye conditions like RPED/CSR or retinal vein occlusion, or I have high eye pressure/glaucoma.My lung cancer cannot be cured with surgery or radiation.I do not have active infections like TB, hepatitis B or C, or HIV.I do not have a stomach or bowel problem that affects how I absorb medicine.I am not using effective birth control and can have children.My cancer can be biopsied, and I am willing to have one.My kidneys are functioning well enough to filter waste.My brain metastases are stable and don't need increasing steroids or seizure meds.My cancer's KRAS mutation status has been tested.I can swallow pills.I am not pregnant and agree to use birth control during and for six months after the study.I haven't taken any experimental cancer drugs or treatments in the last 4 weeks.I have been treated with a MEK, Ras, or Raf inhibitor before.I had no severe side effects from previous immunotherapy that stopped treatment.I haven't had radiation therapy in the last 4 weeks, except for palliative care that didn't target my lungs or lesions used to monitor my disease.I have not received a live vaccine within 30 days before joining the study or before getting durvalumab.I haven't needed extra immunosuppressants beyond corticosteroids for side effects, and I'm not on more than 10 mg of prednisone daily.I have a heart condition that could affect my safety in the trial.I am not currently on any cancer treatments like chemotherapy or immunotherapy.My cancer has worsened after treatment.I haven't had any cancer except skin cancer or cervical cancer in situ in the last 5 years.I have been diagnosed with tuberculosis in the past.I have had cancer spread to the lining of my brain and spinal cord.You have enough infection-fighting white blood cells.Your alkaline phosphatase levels are not too high.Your white blood cell count is at least 3,000 per microliter.I am fully active or can carry out light work.I am willing and able to follow the study's treatment plan and attend all visits.Your liver enzymes (AST or SGOT, and ALT or SGPT) should not be more than 2.5 times the upper limit of normal, or 5 times the upper limit of normal if you have cancer that has spread to your liver.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (intermittent selumetinib, durvalumab, tremelimumab)
- Group 2: Arm II (continuous selumetinib, durvalumab, tremelimumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Is this research project a pioneering endeavor?
"Currently, there are 367 active Selumetinib drug trials in 58 countries and 1337 cities. AstraZeneca first launched a trial for this medication in 2007 with 37 patients taking part in the Phase 2 stage; 181 studies have been conducted since then."
Answered by AI
Is this research project currently enlisting participants?
"As reported on clinicaltrials.gov, this research project is actively enrolling volunteers, with the initial posting date being April 1st 2019 and last modified date October 10th 2022."
Answered by AI
To what medical conditions is Selumetinib typically prescribed?
"Selumetinib is traditionally employed to combat unresectable stage iii non-small cell lung cancer. However, it can also be utilized as a therapy for metastatic ureter urothelial carcinoma and neurofibroma cases that have yet to receive treatment."
Answered by AI
How many participants are being monitored for this clinical investigation?
"Affirmative, according to the information hosted on clinicaltrial.gov this medical trial is actively recruiting patients since its original posting date of April 1st 2019 and updated October 10th 2022. 40 individuals are required to be enrolled at a single centre."
Answered by AI
Are there any prior investigations into the effects of Selumetinib?
"At the moment, Selumetinib is being evaluated in 367 active clinical trials, with 57 of them at Phase 3. Of these studies, most are located in Cordoba Texas but research taking place around 13899 locations worldwide."
Answered by AI
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