Copanlisib for Non-Small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-Small Cell Lung CancerCopanlisib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether adding Copanlisib to Durvalumab will help treat unresectable stage III NSCLC patients who have already undergone chemoradiation.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: approximately 10 years

28 days
Dose Limiting Toxicity
approximately 10 years
Duration of Response
Objective Response Rate
Progression-Free Survival

Trial Safety

Safety Progress

1 of 3

Side Effects for

Combination Therapy
75%Platelet count decreased
75%Lymphocyte count decreased
71%White blood cell decreased
71%Fatigue
67%Anemia
67%Neutrophil count decreased
63%Hypertension
54%Hyperglycemia
50%Nausea
46%Anorexia
46%Diarrhea
46%Lipase increased
42%Alanine aminotransferase increased
42%Abdominal Pain
33%Fever
29%Hyponatremia
25%Hypotension
25%Vomiting
25%Dehydration
25%Hyperkalemia
25%Weight loss
25%Constipation
25%Rash maculo-papular
21%Edema limbs
21%Aspartate aminotransferase increased
21%Serum amylase increased
17%Pain
17%Thromboembolic event
17%Chills
17%Creatinine increased
17%Dizziness
17%Alkaline phosphatase increased
17%Sinus tachycardia
13%Dyspnea
13%Anxiety
13%Non-cardiac chest pain
13%Sepsis
13%Blood bilirubin increased
13%Tinnitus
13%Pain in extremity
13%Generalized muscle weakness
13%Infusion related reaction
13%Upper respiratory infection
13%Gastrointestinal disorders - Other
13%Mucositis oral
13%Hypoalbuminemia
13%Urinary tract infection
8%Depression
8%Back pain
8%General disorders and administration site conditions -Other
8%Hypoxia
8%Insomnia
8%Neck pain
8%Gallbladder obstruction
8%Ascites
8%Dysphagia
8%Bloating
8%Abdominal distension
8%Cough
8%Pleural effusion
8%Dysgeusia
8%Rash acneiform
8%Infections and infestations - Other
8%Pruritus
8%Peripheral sensory neuropathy
4%Colitis
4%Lung infection
4%Colonic obstruction
4%Toothache
4%Allergic reaction
4%Cholecystitis
4%Aspiration
4%Hoarseness
4%Musculoskeletal and connective tissue disorders - Other
4%Urine discoloration
4%Injury, poisoning and procedural complications - Other
4%Paroxysmal atrial tachycardia
4%Cataract
4%Ear pain
4%Bone pain
4%Blood antidiuretic hormone abnormal
4%Postnasal drip
4%Epistaxis
4%Acute kidney injury
4%Hyperuricemia
4%Hiccups
4%Sinus bradycardia
4%Neoplasms benign, malignant and unspecified - Other
4%Hepatic infection
4%Sore throat
4%Hematuria
4%Activated partial thromboplastin time prolonged
4%Infections and Infestations - Other
4%Stomach pain
4%Cystitis noninfective
4%Pericarditis
4%Dry skin
4%Wheezing
4%Pneumonitis
4%Confusion
4%Gastrointestinal disorders -Other
4%Hypomagnesemia
4%Nasal congestion
4%Gastroesophageal reflux disease
4%Malaise
4%Infusion site extravasation
4%Dry mouth
4%Gait disturbance
4%Pancreatitis
4%Urinary tract obstruction
4%Hypernatremia
4%Investigations - Other
4%Hypokalemia
4%Hypercalcemia
4%Headache
4%Parathesia
4%Urine output decreased
4%Atelectasis
4%Gallbladder infection
4%Renal and urinary disorders - Other
4%Productive cough
4%Skin ulceration
4%Phlebitis
4%Dry eye
4%Skin and subcutaneous tissue disorders - Other
4%Fracture
4%Venous injury
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT02631590) in the Combination Therapy ARM group. Side effects include: Platelet count decreased with 75%, Lymphocyte count decreased with 75%, White blood cell decreased with 71%, Fatigue with 71%, Anemia with 67%.

Trial Design

5 Treatment Groups

Copanlisib (30-60mg iv)
1 of 5
Copanlisib (30mg flat dose)
1 of 5
Copanlisib (60mg flat dose)
1 of 5
Copanlisib (45mg flat dose)
1 of 5
Copanlisib (expansion cohort)
1 of 5

Experimental Treatment

18 Total Participants · 5 Treatment Groups

Primary Treatment: Copanlisib · No Placebo Group · Phase 1

Copanlisib (30-60mg iv)Experimental Group · 2 Interventions: Copanlisib, Durvalumab · Intervention Types: Drug, Drug
Copanlisib (30mg flat dose)Experimental Group · 2 Interventions: Copanlisib, Durvalumab · Intervention Types: Drug, Drug
Copanlisib (60mg flat dose)Experimental Group · 2 Interventions: Copanlisib, Durvalumab · Intervention Types: Drug, Drug
Copanlisib (45mg flat dose)Experimental Group · 2 Interventions: Copanlisib, Durvalumab · Intervention Types: Drug, Drug
Copanlisib (expansion cohort)Experimental Group · 2 Interventions: Copanlisib, Durvalumab · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Copanlisib
FDA approved
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 10 years

Who is running the clinical trial?

BayerIndustry Sponsor
2,150 Previous Clinical Trials
23,875,109 Total Patients Enrolled
Zhonglin HaoLead Sponsor
2 Previous Clinical Trials
40 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)

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a normal or near-normal organ and marrow function.
You are able to understand the nature and purpose of the study and are willing to sign a written informed consent document.