Nintedanib for Lung Cancer

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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

There has been limited benefit with angiogenesis inhibitor drugs in molecularly unselected patients in non-small cell lung cancer (NSCLC). The investigators propose that patients who are molecularly selected for treatment with nintedanib based on the presence of mutations in the following genes: VEGFR1-3, PDGFR-A, PDGFR-B, FGFR1-3, and TP53, will have clinically meaningful benefit in terms of response rate (RR) and progression-free survival (PFS). Furthermore the investigators plan to correlate outcomes with specific mutations and evaluate mechanisms of resistance.

Research Team

Ramaswamy Govindan, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+