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PD-L1 Inhibitor
Sirolimus for Non-Small Cell Lung Cancer
Phase 1
Waitlist Available
Led By Jennifer W Carlisle
Research Sponsored by Emory University
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 2 years
Awards & highlights
Study Summary
This trial is studying the side effects and efficacy of sirolimus and durvalumab in treating patients with early-stage non-small cell lung cancer.
Eligible Conditions
- Non-Small Cell Lung Cancer
- Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 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 treatment-related adverse events as assessed by CTCAE v5.0
The effectiveness of sirolimus followed by durvalumab will be assessed by complete pathologic response rate in the efficacy population
Secondary outcome measures
Complete pathologic response rates for PDL-1 negative and PDL-1 positive patients
Other outcome measures
Dose limiting toxicity (DLT)
Side effects data
From 2008 Phase 4 trial • 293 Patients • NCT0011874229%
Diarrhoea
18%
Abdominal Pain
16%
Nausea
16%
Headache
16%
Fatigue
16%
Hepatitis C
14%
Vomiting
14%
Pyrexia
14%
Leukopenia
12%
Oedema Peripheral
11%
Insomnia
10%
Anaemia
10%
Hyperkalaemia
10%
Tremor
10%
Back Pain
10%
Hypertension
9%
Cough
9%
Pruritis
9%
Arthralgia
8%
Neutropenia
8%
Abdominal Pain Upper
8%
Dizziness
8%
Pain in Extremity
8%
Hepatic Enzyme Increased
7%
Dyspnoea
7%
Constipation
7%
Sinusitis
7%
Weight Decreased
6%
Blood Creatinine Increased
6%
Liver Function Test Abnormal
6%
White Blood Cell Count Decreased
5%
Jaundice
5%
Renal Failure
5%
Muscle Spasms
5%
Decreased Appetite
5%
Weight Increased
5%
Upper Respiratory Tract Infection
5%
Nasopharyngitis
5%
Asthenia
5%
Incision Site Pain
5%
Depression
4%
Anorexia
4%
Night Sweats
4%
Oropharyngeal Pain
4%
Rhinorrhoea
3%
Myalgia
3%
Pleural Effusion
3%
Hyperlipidaemia
3%
Thrombocytopenia
3%
Rash
3%
Acne
3%
Incisional Hernia
2%
Sepsis
2%
Pneumonia
2%
Hypokalaemia
1%
Gastritis
1%
Urinary Retention
1%
Abdominal Hernia
1%
Non-Small Cell Lung Cancer Metastatic
1%
Multi-Organ Failure
1%
Benign Prostatic Hyperplasia
1%
Hypoglycaemia
1%
Crohn's Disease
1%
Clostridium Difficile Colitis
1%
Inappropriate Antidiuretic Hormone Secretion
1%
Hepatic Neoplasm Malignant
1%
Ventricular Tachycardia
1%
Blood Alkaline Phosphatase Increased
1%
Hepatic Failure
1%
Renal Failure Acute
1%
Chest Pain
1%
Cerebral Haemorrhage
1%
Gastrointestinal Haemorrhage
1%
Cardiac Failure Congestive
1%
Hepatic Artery Stenosis
1%
Portal Vein Thrombosis
1%
Epstein-Barr Virus Associated Lymphoproliferative Disorder
1%
Gastrointestinal Tract Adenoma
1%
Febrile Neutropenia
1%
Encephalopathy
1%
Atrial Flutter
1%
Blood Glucose Increased
1%
Transplant Rejection
1%
Confusional State
1%
Spinal Osteoarthritis
1%
Hypercholesterolaemia
1%
Convulsion
1%
Peritonitis
1%
Haemorrhage Intracranial
1%
Deep Vein Thrombosis
1%
Inguinal Hernia
1%
Viral Infection
1%
Acarodermatitis
1%
Atrial Fibrillation
1%
Malaise
1%
Hepatic Cancer Metastatic
1%
Adenocarcinoma
1%
B-Cell Lymphoma
1%
Desmoid Tumour
1%
Pulmonary Embolism
1%
Stomatitis
1%
Influenza
1%
Staphylococcal Infection
1%
Umbilical Hernia
1%
Hepatic Function Abnormal
1%
Hyponatraemia
1%
Bacteraemia
1%
Cellulitis
1%
Clostridial Infection
1%
Diverticulitis
1%
Escherichia Urinary Tract Infection
1%
Lactobacillus Infection
1%
Lobar Pneumonia
1%
Pseudomonal Sepsis
1%
Post Procedural Haemorrhage
1%
Procedural Pain
1%
Biliary Anastomosis Complication
1%
Complications of Transplanted Kidney
1%
Bile Duct Obstruction
1%
Bile Duct Stenosis
1%
Biliary Tract Disorder
1%
Autoimmune Hepatitis
1%
Cholestasis
1%
Lung Disorder
1%
Pulmonary Oedema
1%
Sinus Congestion
1%
Embolism Venous
1%
Orthostatic Hypotension
1%
Vasculitis
1%
Hyperglycaemia
1%
Graft Versus Host Disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
CellCept + CNI (Tacrolimus or Cyclosporine)
CellCept + Sirolimus
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (sirolimus, durvalumab)Experimental Treatment2 Interventions
Patients receive sirolimus PO QD on days 1-21 in the absence of disease progression or unacceptable toxicity. Starting on day 22, patients receive durvalumab IV over 1 hour. Treatment with durvalumab repeats every 21 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Within a 2-3 week period after the second dose of durvalumab, but not earlier than two weeks after the administration of durvalumab, patients undergo standard of care surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
2013
Completed Phase 4
~2750
Durvalumab
2017
Completed Phase 2
~3870
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,529 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,486 Total Patients Enrolled
Jennifer W CarlislePrincipal InvestigatorEmory University Hospital/Winship Cancer Institute
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Sirolimus as a safe and viable treatment option?
"Due to the limited clinical data available, our team rated sirolimus' safety at a score of 1. This is because this trial is still in its first phase, with few studies having observed efficacy or security."
Answered by AI
Could you please inform us of any other experiments related to Sirolimus that have been conducted?
"At present, 456 investigations are underway to study sirolimus. 65 of these trials have advanced to Phase 3 and the majority are based in Cincinnati, Ohio; however, there exists a total of 14024 research sites around the world."
Answered by AI
In what medical scenarios is Sirolimus typically employed?
"Sirolimus is a medication used to prevent organ transplant rejection, as well as treating issues concerning the liver, kidney and lung."
Answered by AI
How many participants are admitted to this research project?
"At present, this research is not accepting new enrollees. Originally posted on January 22nd 2021 and last updated August 22nd 2022, individuals seeking clinical trials can find 2045 studies recruiting for stage ia2 lung cancer ajcc v8 and 456 looking for participants to receive Sirolimus treatments."
Answered by AI
Is there still opportunity to enrol in this experiment?
"As indicated by clinicaltrials.gov, this particular trial is not presently recruiting participants. It was initially advertised on January 22nd 2021 and last updated on August 22nd 2022. Although applications for this study are currently paused, there remains 2500 other investigations that require volunteers right now."
Answered by AI
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