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Angiogenesis Inhibitor

Nintedanib for Lung Cancer

Phase 2
Waitlist Available
Led By Ramaswamy Govindan, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least one measurable lesion or evaluable disease. Measurable disease is defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥10 mm with CT scan, as ≥20 mm by chest x-ray, or ≥10 mm with calipers by clinical exam.
ECOG performance status 0-1
Must not have
Leptomeningeal disease.
Major injuries and/or surgery with then past 4 weeks prior to the start of study treatment with incomplete wound healing and/or planned surgery during the on-treatment study period.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months follow-up minimum
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether a drug that targets specific mutations will be more effective in treating NSCLC than current drugs that are not targeted.

Who is the study for?
Adults with advanced NSCLC who have specific gene mutations and have progressed after standard treatments can join. They must be in good physical condition, not pregnant, willing to use contraception, and without recent serious illnesses or other cancers within the last 5 years.
What is being tested?
The trial is testing Nintedanib on patients with certain genetic markers in their cancer cells. It aims to see if this drug improves response rates and slows down cancer progression compared to previous outcomes in unselected patients.
What are the potential side effects?
Nintedanib may cause liver issues, high blood pressure, bleeding problems, stomach upset or diarrhea. There's also a risk of blood clots or heart attacks especially for those with a history of such conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor that can be measured by scans or physical exam.
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I am fully active or can carry out light work.
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My blood, liver, and kidney functions are within normal ranges.
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My cancer progressed despite treatment for my specific genetic changes.
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My cancer got worse after platinum-based chemotherapy.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to the lining of my brain and spinal cord.
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I haven't fully healed from major surgery or injuries in the last 4 weeks.
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I have a genetic condition that affects my blood's ability to clot.
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I have had a significant bleeding or clotting event in the last 6 months.
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I have lost more than 10% of my body weight in the last 6 months.
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I have been treated with VEGFR inhibitors before.
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I have an active or chronic hepatitis B or C infection.
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My tumor is near the center of my body and is affecting major blood vessels.
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I do not have stomach or intestine problems that affect medication absorption.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months follow-up minimum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months follow-up minimum for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Response Rate (RR)
Secondary study objectives
Genetic Mechanisms of Secondary Resistance
Median Progression-free Survival (PFS)
Unique Genetic Variations Associated With Extreme Responders (Both Non-responders and Responders)

Side effects data

From 2021 Phase 3 trial • 752 Patients • NCT01619085
70%
Diarrhoea
23%
Cough
21%
Nasopharyngitis
21%
Idiopathic pulmonary fibrosis
20%
Nausea
20%
Bronchitis
20%
Viral upper respiratory tract infection
17%
Weight decreased
16%
Dyspnoea
15%
Upper respiratory tract infection
14%
Decreased appetite
13%
Pneumonia
12%
Vomiting
9%
Fatigue
9%
Abdominal pain
8%
Constipation
8%
Back pain
7%
Pulmonary hypertension
7%
Abdominal pain upper
7%
Oedema peripheral
7%
Arthralgia
7%
Hypertension
7%
Dizziness
6%
Headache
6%
Pyrexia
6%
Respiratory tract infection
5%
Asthenia
5%
Lower respiratory tract infection
5%
Respiratory failure
5%
Chest pain
5%
Rhinitis
5%
Productive cough
5%
Insomnia
5%
Lung infection
5%
Influenza
4%
Anxiety
4%
Cataract
3%
Myalgia
2%
Hypoxia
2%
Pneumothorax
2%
Pulmonary embolism
2%
Pulmonary fibrosis
2%
Acute respiratory failure
2%
Cardiac failure
2%
Lung neoplasm malignant
1%
Atrial fibrillation
1%
Haemoptysis
1%
Cardiac arrest
1%
Cardiac failure congestive
1%
Cor pulmonale
1%
Coronary artery disease
1%
Coronary artery stenosis
1%
Right ventricular failure
1%
Interstitial lung disease
1%
Inguinal hernia
1%
Sudden death
1%
Cholecystitis acute
1%
Pneumonia bacterial
1%
Sepsis
1%
Fall
1%
Rib fracture
1%
Dehydration
1%
Lung adenocarcinoma
1%
Prostate cancer
1%
Small cell lung cancer
1%
Squamous cell carcinoma of skin
1%
Syncope
1%
Pulmonary arterial hypertension
1%
Renal failure
1%
Benign prostatic hyperplasia
1%
Gastrointestinal haemorrhage
1%
Basal cell carcinoma
1%
Transient ischaemic attack
1%
Myocardial infarction
1%
Cholelithiasis
1%
Urinary tract infection
1%
Femur fracture
1%
Squamous cell carcinoma
1%
Acute kidney injury
1%
Pulmonary oedema
1%
Acute myocardial infarction
1%
Angina pectoris
1%
Myocardial ischaemia
1%
Haemorrhoids
1%
Pancreatitis
1%
Multiple organ dysfunction syndrome
1%
Hepatic enzyme increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo (1199.187)
Total (1199.32/.34)
Nintedanib 150 Bid (1199.35/.187)
Total (1199.35/.187)
Total (1199.32/.34/.35/.187)
Placebo (1199.32/.34)
Nintedanib 100 Bid (1199.35)
Nintedanib 150 Bid (1199.32/.34)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: NintedanibExperimental Treatment1 Intervention
-Nintedanib will be administered orally at a dose of 200 mg twice daily during each 28 day cycle. Starting with cycle 64, cycles will last 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nintedanib
2015
Completed Phase 3
~3950

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
2,000 Previous Clinical Trials
2,344,242 Total Patients Enrolled
National Comprehensive Cancer NetworkNETWORK
120 Previous Clinical Trials
7,380 Total Patients Enrolled
Ramaswamy Govindan, M.D.Principal InvestigatorWashington University School of Medicine
9 Previous Clinical Trials
370 Total Patients Enrolled
~2 spots leftby Dec 2025
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