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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months follow-up minimum

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months follow-up minimum

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response Rate (RR)

Secondary outcome measures

Genetic Mechanisms of Secondary Resistance

Median Progression-free Survival (PFS)

Response Rate by Mutation Type

+1 more

Side effects data

From 2017 Phase 4 trial • 105 Patients • NCT02579603

31%

Diarrhoea

16%

Dyspnoea

12%

Vomiting

12%

Nausea

12%

Fatigue

10%

Decreased appetite

Abdominal pain upper

Asthenia

Dizziness

Weight decreased

Abdominal pain

Contusion

Cough

Bronchitis

Nasopharyngitis

Gastrooesophageal reflux disease

Atrial flutter

Transient ischaemic attack

Phlebitis

Constipation

Alanine aminotransferase increased

Aspartate aminotransferase increased

Pyrexia

Acute respiratory failure

Pancreatitis acute

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Nintedanib

Nintedanib + Pirfenidone

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 4

~3680

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,689 Total Patients Enrolled

National Comprehensive Cancer NetworkNETWORK

115 Previous Clinical Trials

7,615 Total Patients Enrolled

Ramaswamy Govindan, M.D.Principal InvestigatorWashington University School of Medicine

9 Previous Clinical Trials

370 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the government's thoughts on Nintedanib?

"Nintedanib was given a 2 out of 3 for safety because, while there is evidence that it is safe, none of the clinical data supports its efficacy."

Answered by AI

How many study participants are there in total?

"This particular study is not looking for new participants at the moment. However, it's worth noting that this research was last updated on 10/19/2022 and was originally posted on 5/7/2015. If you're interested in other studies, 2098 trials are actively searching for patients with carcinoma, non-small-cell lung and 22 studies involving Nintedanib are also admitting patients."

Answered by AI

Are there other ongoing research projects that use Nintedanib?

"At the moment, there are 22 ongoing studies researching Nintedanib. Of those, 5 are in Phase 3. The vast majority of these trials take place in Chicago, Illinois; however, there are a total of 281 locations running Nintedanib trials."

Answered by AI

What symptoms does Nintedanib help to ameliorate?

"Nintedanib is a possible treatment for adenocarcinoma, metastatic non-small cell lung cancer (nsclc) caused by adenocarcinoma, and other pharmacotherapy."

Answered by AI

Are there any participants needed for this clinical trial at this time?

"Unfortunately, this particular clinical trial is not looking for new participants at the moment. It was originally posted on May 7th, 2015 but hasn't been updated in a while. There are however, 2120 other trials that are actively recruiting patients right now."

Answered by AI

What other research is similar to this medical trial?

"Nintedanib has been the focus of medical research since 2012 when it was first trialed by Boehringer Ingelheim. The drug received Phase 1 & 2 approval after the initial trial yielded positive results in 140 patients. Now, there are 22 clinical trials involving Nintedanib across 53 cities and 30 countries."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer

2015. "Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02299141.

All > Non Small Cell Lung Cancer > Sclc