What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy drugs like cisplatin and paclitaxel can cause nausea, vomiting, hair loss, fatigue, and increased infection risk. Targeted therapies, such as EGFR antagonists, may result in skin rashes, diarrhea, and liver issues. Immunotherapy, including PD-1/PD-L1 inhibitors, can lead to immune-related side effects like colitis, pneumonitis, and thyroid dysfunction.

What prior FDA approvals exist?

Several FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) include immune checkpoint inhibitors such as pembrolizumab and atezolizumab, often used in combination with chemotherapy agents like pemetrexed, carboplatin, and nab-paclitaxel. EGFR tyrosine kinase inhibitors (EGFR-TKIs) are also approved for NSCLC with specific mutations. These treatments have shown efficacy in various clinical trials, including KEYNOTE-189 and IMpower150, which evaluated combinations of immunotherapy and chemotherapy for advanced and metastatic NSCLC.

What other types of research exist?

Promising novel alternatives for NSCLC patients include the combination of atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP), which has shown improved progression-free survival (PFS) and overall survival (OS) in the IMpower 150 trial. Additionally, the combination of pembrolizumab and chemotherapy has also demonstrated efficacy. These regimens are particularly suitable for patients without EGFR mutations or ALK translocations.

← Back to Search

Other

NBF-006 for Cancer

Phase 1

Waitlist Available

Research Sponsored by Nitto BioPharma, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate renal function, defined as serum creatinine ≤ 1.5 x upper limit of normal (ULN) for the institution or calculated creatinine clearance [Cockcroft-Gault method] must be ≥ 60 mL/min/1.73 m². If serum creatinine is >1.5 x ULN, then creatinine clearance can be calculated from a 24-hour urine collection.

Patients with histologically or cytologically confirmed progressive or metastatic NSCLC with documented KRAS-mutant genotype, who have failed standard treatment and have no other effective treatment available or appropriate for the patient.

Must not have

Significant cardiovascular disease or condition, including: Congestive heart failure currently requiring therapy, Need for antiarrhythmic medical therapy for ventricular arrhythmia, Severe conduction disturbance, Angina pectoris requiring therapy, QTc interval > 450 msec (males) or > 470 msec (females) Fridericia's correction. Note: QTc values up to 500 ms will be acceptable where patient's medical history e.g. bundle branch block, is known to cause mild QTc prolongation and the condition is well controlled, History of congenital long QT syndrome or congenital short QT syndrome, Uncontrolled hypertension (per the Investigator's discretion), Class III or IV cardiovascular disease according to the New York Heart Association's Functional Criteria, Myocardial infarction within 6 months prior to first study drug administration.

Known uncontrolled intercurrent illnesses, including uncontrolled viral influenza and COVID 19, systemic bacterial infections, and fungal infections.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72 hours from start of infusion on cycle 1, day 1 and day 22 and prior to infusion cycle 1, day 8 and cycle 2, day 1

Awards & highlights

No Placebo-Only Group

Summary

This trial tests different doses of a new cancer treatment on patients whose cancers have not responded to previous treatments, focusing on those with a specific genetic mutation (KRAS). The goal is to find the safest and most effective dose.

Who is the study for?

This trial is for adults (18+) with certain types of advanced cancers (NSCLC, pancreatic, colorectal) that have worsened despite standard treatments. Participants must have good liver and kidney function, not be pregnant or breastfeeding, agree to use contraception, and cannot have HIV or active hepatitis B/C infections. They should not have had recent chemotherapy or suffer from severe psychiatric disorders or uncontrolled heart disease.

What is being tested?

NBF-006 is being tested in patients with specific advanced cancers. The study has two parts: Part A finds the best dose of NBF-006 and Part B sees how well it works at that dose. It's an open-label trial which means everyone knows what treatment they're getting; there's no placebo group.

What are the potential side effects?

While the exact side effects of NBF-006 are not listed here, similar cancer drugs often cause fatigue, nausea, diarrhea, blood count changes increasing infection risk, liver and kidney issues. Allergic reactions are possible too.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My kidney function is within the normal range required.

Select...

My advanced lung cancer has a KRAS mutation and standard treatments have failed.

Select...

My cancer has spread, standard treatments failed, and no other treatments are suitable.

Select...

My blood tests show enough white blood cells and platelets.

Select...

My liver tests are within the required range.

Select...

I am able to get out of my bed or chair and move around.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have severe heart problems or uncontrolled high blood pressure.

Select...

I do not have any uncontrolled illnesses like the flu, COVID-19, or infections.

Select...

I am not pregnant or breastfeeding, and if capable of becoming pregnant, I have a negative pregnancy test.

Select...

I have a history of HIV or active hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 72 hours from start of infusion on cycle 1, day 1 and day 22 and prior to infusion cycle 1, day 8 and cycle 2, day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 72 hours from start of infusion on cycle 1, day 1 and day 22 and prior to infusion cycle 1, day 8 and cycle 2, day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 hours from start of infusion on cycle 1, day 1 and day 22 and prior to infusion cycle 1, day 8 and cycle 2, day 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Additional pharmacokinetic parameters for siRNA

Best Overall Response per RECIST 1.1

Pharmacokinetic parameters for siRNA

Other study objectives

To evaluate correlation between biomarkers and clinical outcome

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: NBF-006Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NBF-006

2019

Completed Phase 1

~50

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy kills rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors (TKIs), focus on specific genetic mutations or proteins that drive cancer growth, offering a more precise treatment with potentially fewer side effects. Immunotherapy, including immune checkpoint inhibitors like anti-PD-1 and anti-PD-L1 antibodies, boosts the body's immune response against cancer cells. These treatments are vital for NSCLC patients as they provide multiple strategies to control and potentially eliminate the cancer, thereby improving survival rates and quality of life.

Large Cell Neuro-Endocrine Carcinoma of the Lung: Current Treatment Options and Potential Future Opportunities.Management of patients with lung cancer and poor performance status.Systemic therapy for lung cancer brain metastases: a rationale for clinical trials.