Nintedanib for Lung Cancer

No longer recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Must not be taking: VEGFR inhibitors, Anticoagulants

Disqualifiers: Symptomatic brain metastases, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 8 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a drug called nintedanib for treating advanced non-small cell lung cancer (NSCLC). The researchers aim to determine if patients with specific genetic mutations, such as those involving VEGFR or TP53 genes, respond better to this treatment. The trial seeks patients whose cancer has progressed despite previous treatments like chemotherapy or targeted therapies. Patients diagnosed with advanced NSCLC and possessing these specific genetic markers might be a good fit for this study. As a Phase 2 trial, the research focuses on measuring how well the treatment works in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are on certain investigational agents, therapeutic anticoagulation, or anti-platelet therapy, except for low-dose aspirin. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that nintedanib is likely to be safe for humans?

Research has shown that nintedanib may help treat non-small cell lung cancer (NSCLC). Studies have found that combining this drug with docetaxel is effective and generally safe, meaning most patients tolerate the treatment well, with serious side effects being rare.

In other studies, patients who took nintedanib experienced improvements even after other treatments failed. This suggests that nintedanib could be a viable option for those with advanced NSCLC. While some side effects might occur, the overall safety profile is encouraging for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lung cancer?

Nintedanib is unique because it targets multiple pathways involved in lung cancer growth, specifically the receptors for vascular endothelial growth factor, platelet-derived growth factor, and fibroblast growth factor. These pathways play crucial roles in tumor blood vessel formation and cancer cell proliferation. Unlike traditional chemotherapies that target rapidly dividing cells indiscriminately, nintedanib's targeted approach may offer a more precise attack on cancer cells, potentially leading to fewer side effects. Researchers are excited about nintedanib because it could provide a more effective and potentially safer option for patients with lung cancer compared to existing treatments.

What evidence suggests that nintedanib might be an effective treatment for lung cancer?

Research has shown that nintedanib can help treat non-small cell lung cancer (NSCLC), especially when combined with docetaxel. In some studies, patients who received both nintedanib and docetaxel responded better to treatment, and their cancer remained stable for a longer period. Specifically, one study found that this combination improved progression-free survival, meaning the cancer did not worsen during and after treatment, compared to a placebo. This suggests that nintedanib can help slow lung cancer, particularly in patients with certain gene mutations. Evidence indicates that nintedanib is promising for those with specific gene changes like VEGFR and FGFR.

In this trial, participants will receive nintedanib as a standalone treatment to further evaluate its effectiveness in treating NSCLC. ^{1 3 5 6 7}

Who Is on the Research Team?

Ramaswamy Govindan, M.D.

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have a tumor that can be measured by scans or physical exam.

Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 3 months after the end of treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

I am fully active or can carry out light work.

Exclusion Criteria

I have brain metastases but no symptoms, or they've been treated.

Your medical images show tumors with holes or dead tissue inside.

I do not have any serious ongoing illnesses that my doctor is still trying to control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Nintedanib is administered orally at a dose of 200 mg twice daily during each 28-day cycle

8 months

Monthly visits for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Nintedanib

Trial Overview 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.

How Is the Trial Designed?

Group I: Nintedanib Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Comprehensive Cancer Network

Collaborator

Trials

121

Recruited

7,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10449572/

Efficacy and safety of nintedanib in patients with non-small ... Patients who received nintedanib plus docetaxel as a second-line therapeutic had good results: IPF was stabilized, and the lung cancer regressed ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37665737/

Efficacy and safety of nintedanib and docetaxel in patients ... The majority of patients (n = 47,49%) received docetaxel plus nintedanib as third-line therapy. The ORR for this subset of patients was 19.1%, ...

3. publications.ersnet.org publications.ersnet.org/content/erj/60/6/2200380

Nintedanib plus chemotherapy for nonsmall cell lung cancer ... Another phase 3 trial revealed that nintedanib in combination with carboplatin and paclitaxel improved progression-free survival (PFS) in patients with advanced ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S093665552100491X

Real-World Efficacy of Nintedanib Plus Docetaxel After ... Nintedanib plus docetaxel demonstrated a high response rate and disease stabilisation in the third-line setting after failure of prior chemotherapy and ICI ...

5. lungcancerjournal.info lungcancerjournal.info/article/S0169-5002(20)30576-6/fulltext

Non-interventional LUME-BioNIS study of nintedanib plus ... In combination with docetaxel, nintedanib was shown to significantly increase progression-free survival (PFS) compared with placebo plus ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2468294225000991

A Galician Lung Cancer Group study Nintedanib and docetaxel demonstrated meaningful efficacy and an acceptable safety profile in advanced NSCLC after immunotherapy and chemotherapy failure.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01948141

Nintedanib in Treating Patients With Advanced Non-Small ... This phase II trial studies how well nintedanib works in treating patients with advanced non-small cell lung cancer who have failed up to two previous ...