Your session is about to expire
← Back to Search
PD-L1 Inhibitor
Copanlisib + Durvalumab for Lung Cancer (LCD Trial)
Phase 1
Waitlist Available
Led By Zhonglin Hao, MD
Research Sponsored by Zhonglin Hao
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed NSCLC (e.g., adenocarcinoma, squamous cell) deemed unresectable or inoperable who have received concurrent chemoradiation
ECOG performance status ≤2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 10 years
Awards & highlights
LCD Trial Summary
This trial is testing whether adding Copanlisib to Durvalumab will help treat unresectable stage III NSCLC patients who have already undergone chemoradiation.
Who is the study for?
This trial is for adults with stage III non-small cell lung cancer (NSCLC) that can't be removed by surgery. They should have received chemoradiation and are about to start Durvalumab therapy. Participants need at least one measurable lesion, good performance status, proper organ function, and must understand and sign consent forms. People with certain heart conditions, mixed lung cancers, specific gene mutations, or on prohibited medications cannot join.Check my eligibility
What is being tested?
The study tests if adding Copanlisib to Durvalumab after chemoradiation improves outcomes in NSCLC patients aiming for a cure. It examines the safety of combining these drugs biweekly and whether this combination can help overcome resistance to Durvalumab alone.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the drug administration process, fatigue, blood disorders like anemia or clotting issues, increased risk of infections due to immune suppression.
LCD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is confirmed and cannot be removed by surgery, but I have had chemoradiation.
Select...
I can take care of myself but might not be able to do heavy physical work.
LCD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Limiting Toxicity
Secondary outcome measures
Duration of Response
Objective Response Rate
Progression-Free Survival
Side effects data
From 2021 Phase 2 trial • 24 Patients • NCT0263159075%
Platelet count decreased
75%
Lymphocyte count decreased
71%
White blood cell decreased
71%
Fatigue
67%
Neutrophil count decreased
67%
Anemia
63%
Hypertension
54%
Hyperglycemia
50%
Nausea
46%
Lipase increased
46%
Diarrhea
46%
Anorexia
42%
Alanine aminotransferase increased
42%
Abdominal Pain
33%
Fever
29%
Hyponatremia
25%
Hyperkalemia
25%
Constipation
25%
Vomiting
25%
Weight loss
25%
Dehydration
25%
Hypotension
25%
Rash maculo-papular
21%
Serum amylase increased
21%
Aspartate aminotransferase increased
21%
Edema limbs
17%
Alkaline phosphatase increased
17%
Creatinine increased
17%
Sinus tachycardia
17%
Chills
17%
Pain
17%
Thromboembolic event
17%
Dizziness
13%
Pain in extremity
13%
Generalized muscle weakness
13%
Gastrointestinal disorders - Other
13%
Mucositis oral
13%
Anxiety
13%
Tinnitus
13%
Infusion related reaction
13%
Non-cardiac chest pain
13%
Blood bilirubin increased
13%
Hypoalbuminemia
13%
Dyspnea
13%
Sepsis
13%
Upper respiratory infection
13%
Urinary tract infection
8%
Back pain
8%
Neck pain
8%
Depression
8%
Gallbladder obstruction
8%
Abdominal distension
8%
Ascites
8%
Bloating
8%
Dysphagia
8%
General disorders and administration site conditions -Other
8%
Cough
8%
Hypoxia
8%
Pleural effusion
8%
Pruritus
8%
Rash acneiform
8%
Infections and infestations - Other
8%
Insomnia
8%
Dysgeusia
8%
Peripheral sensory neuropathy
4%
Infections and Infestations - Other
4%
Cataract
4%
Lung infection
4%
Pancreatitis
4%
Toothache
4%
Stomach pain
4%
Wheezing
4%
Hoarseness
4%
Hepatic infection
4%
Productive cough
4%
Gastrointestinal disorders -Other
4%
Sore throat
4%
Cholecystitis
4%
Nasal congestion
4%
Pneumonitis
4%
Postnasal drip
4%
Urinary tract obstruction
4%
Bone pain
4%
Musculoskeletal and connective tissue disorders - Other
4%
Gallbladder infection
4%
Paroxysmal atrial tachycardia
4%
Pericarditis
4%
Sinus bradycardia
4%
Ear pain
4%
Dry eye
4%
Fracture
4%
Neoplasms benign, malignant and unspecified - Other
4%
Colitis
4%
Colonic obstruction
4%
Dry mouth
4%
Gastroesophageal reflux disease
4%
Infusion site extravasation
4%
Malaise
4%
Activated partial thromboplastin time prolonged
4%
Blood antidiuretic hormone abnormal
4%
Investigations - Other
4%
Urine output decreased
4%
Hypercalcemia
4%
Hypernatremia
4%
Hyperuricemia
4%
Hypokalemia
4%
Hypomagnesemia
4%
Phlebitis
4%
Aspiration
4%
Atelectasis
4%
Epistaxis
4%
Hiccups
4%
Dry skin
4%
Skin and subcutaneous tissue disorders - Other
4%
Skin ulceration
4%
Confusion
4%
Acute kidney injury
4%
Cystitis noninfective
4%
Hematuria
4%
Renal and urinary disorders - Other
4%
Urine discoloration
4%
Injury, poisoning and procedural complications - Other
4%
Gait disturbance
4%
Headache
4%
Parathesia
4%
Venous injury
4%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combination Therapy
LCD Trial Design
1Treatment groups
Experimental Treatment
Group I: Copanlisib (30-60mg iv)Experimental Treatment2 Interventions
Patients in the group will receive Durvalumab at 10mg/kg (IV infusion on days 1 and 15, q28 days or 1500mg day 1 q28d). They will also receive Copanlisib ranging from 30mg to 60mg (IV infusion on days 1 and 15, q 28 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3870
Copanlisib
2016
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
Zhonglin HaoLead Sponsor
3 Previous Clinical Trials
37 Total Patients Enrolled
BayerIndustry Sponsor
2,240 Previous Clinical Trials
25,332,766 Total Patients Enrolled
Zhonglin Hao, MDPrincipal Investigator - University of Kentucky
University of Kentucky, University of Kentucky Albert B. Chandler Hospital
Inner Mongolia Medical College (Medical School)
Medical Ctr Of Central Ga (Residency)
1 Previous Clinical Trials
33 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had any major surgeries in the last 28 days.I have not had serious bleeding issues in the last month.I have received chemotherapy and radiation therapy one after the other.I do not have any unstable illnesses that could affect my safety in the study.My lung cancer has both non-small and small cell types with known EGFR or ALK mutations.My lung cancer is confirmed and cannot be removed by surgery, but I have had chemoradiation.I have an autoimmune disease and have been on immunosuppressants in the last 2 years.You have a mental illness or social situation that might make it hard for you to follow the study rules, or you have a seizure disorder that is not well controlled.My heart condition severely limits my physical activity.I am not taking any medications that the study does not allow.I take more than 10 mg of prednisone daily for a condition other than my cancer.You have severe protein in your urine.I have not received a live vaccine in the last 4 weeks.I have had a blood clot in the last 3 months.I have not had a heart attack in the last 6 months.I will start Durvalumab as a follow-up treatment.I have received a solid organ or bone marrow transplant.You have at least one spot that can be measured to see if the treatment is working.I have a lung condition or severe breathing problems.I can take care of myself but might not be able to do heavy physical work.My organs and bone marrow are working well.I have unstable chest pain.I do not have any unmanaged ongoing illnesses.
Research Study Groups:
This trial has the following groups:- Group 1: Copanlisib (30-60mg iv)
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.
How many participants are currently involved in this clinical research project?
"Affirmative. According to the clinicaltrials.gov database, this study was implemented on May 12th 2021 and has been actively seeking out participants since then. The current iteration of the trial is scheduled for 18 patients at 1 medical facility."
Answered by AI
Is there a heightened risk associated with Copanlisib usage?
"Copanlisib has a safety rating of 1 since this is an early Phase 1 clinical trial, which indicates limited available data on its efficacy and safety."
Answered by AI
What are the other research projects that have utilized Copanlisib?
"Currently, a total of 362 studies examining Copanlisib are active. Of these trials, 54 are in Phase 3 development. The primary site for this research is located in Sutton, Texas; though there exist 15,059 sites offering the treatment."
Answered by AI
What diseases does Copanlisib commonly address?
"Patients suffering from follicular lymphoma, stage III unresectable non-small cell lung cancer and other diseases can be treated with the medicine Copanlisib."
Answered by AI
Is this experiment still recruiting participants?
"Yes. Based on the information recorded in clinicaltrials.gov, this medical trial is presently recruiting volunteers and was initially uploaded to the platform on May 12th 2021. The study has since been updated with new data as of February 21st 2022 and requires 18 participants from a single site."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger