What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy agents like docetaxel, nivolumab, atezolizumab, cisplatin, and pemetrexed. These treatments are associated with a range of side effects. Docetaxel can cause neutropenia, fatigue, and neuropathy. Nivolumab and atezolizumab, which are immunotherapy agents, may lead to immune-related adverse effects such as pneumonitis, colitis, and hepatitis. Cisplatin is known for nephrotoxicity, ototoxicity, and severe nausea and vomiting. Pemetrexed can cause hematologic toxicity, fatigue, and gastrointestinal disturbances. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Small Cell Lung Cancer (NSCLC), including targeted therapies, immunotherapies, and chemotherapies. Targeted therapies such as erlotinib, gefitinib, and osimertinib focus on specific genetic mutations like EGFR. Immunotherapies, including pembrolizumab and nivolumab, enhance the immune system's ability to fight cancer. Chemotherapies like cisplatin, carboplatin, and paclitaxel are also commonly used. The investigational drug FWD1509 MsOH appears to be a novel therapeutic agent, and its study aims to establish its safety and optimal dosing in advanced NSCLC patients.

What other types of research exist?

Promising novel alternatives to FWD1509 MsOH for NSCLC patients include dacomitinib, which has shown clinical efficacy in patients with rare EGFR mutations, and the combination of gemcitabine/cisplatin with or without sorafenib, although the latter did not meet its primary endpoint of improved overall survival. Further studies and identification of predictive biomarkers are warranted to optimize these treatments.

← Back to Search

Unknown

FWD1509 for Lung Cancer (FWD1509 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by Forward Pharmaceuticals Co., Ltd.

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB/IIIC or IV)

Previously treated with one or more regimens of systemic therapy for locally advanced or metastatic disease

Must not have

Received anticancer therapy ≤ 21 days prior to first dose of FWD1509 MsOH; or received prior EGFR TKIs ≤7 days prior to the first dose FWD1509 MsOH

Have current spinal cord compression or leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new oral medication called FWD1509 MsOH in patients with advanced lung cancer who have specific genetic mutations. The medicine works by blocking proteins that help cancer cells grow, especially in cases where other treatments have failed.

Who is the study for?

Adults with advanced non-small cell lung cancer (NSCLC) who've had at least one prior systemic therapy can join this trial. They need a measurable tumor, good performance status, and adequate organ function. Major surgery within the last 28 days or certain health conditions like uncontrolled heart disease disqualify participation.

What is being tested?

The study is testing FWD1509 MsOH's safety and determining the highest dose patients with NSCLC can tolerate without severe side effects. It aims to find the optimal phase 2 dose based on how well participants handle it.

What are the potential side effects?

While specific side effects of FWD1509 MsOH are not listed, common ones in cancer trials include nausea, fatigue, risk of infection due to low blood counts, liver issues, and potential heart problems.

Eligibility Criteria

Inclusion Criteria

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

Select...

My lung cancer is at an advanced stage (Stage IIIB/IIIC or IV).

Select...

I have been treated with medication for my advanced or spread cancer.

Select...

I have enough tumor tissue available for testing.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

Select...

I haven't had cancer treatment in the last 21 days, or EGFR inhibitors in the last 7 days.

Select...

I have spinal cord compression or cancer spread to the lining of my brain.

Select...

I am currently pregnant, breastfeeding, or lactating.

Select...

I have serious heart problems that are not under control.

Select...

I do not have severe heart, kidney, eye diseases, uncontrolled high blood pressure, lung conditions, or active infections.

Select...

I had radiotherapy less than 2 weeks ago or still have side effects.

Select...

I have not had major surgery in the last 4 weeks.

Select...

I do not have stomach or bowel problems affecting medication absorption.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

22-30 participants with treatment-related adverse events as assessed based on CTCAE v5.0.

Secondary study objectives

DCR: Disease Control Rate

DoR: Duration of Response

ORR: Objective Response Rate

+3 more

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: Treatment of NSCLC patients with EGFR or HER2 genetic alterationsExperimental Treatment1 Intervention

0 / 12Eligibility 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

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, immunotherapies, and traditional chemotherapies. Targeted therapies, such as tyrosine kinase inhibitors, work by specifically targeting and inhibiting the function of proteins that promote cancer cell growth and survival. Immunotherapies, like PD-1/PD-L1 inhibitors, enhance the body's immune response against cancer cells by blocking the proteins that prevent immune cells from attacking tumors. Traditional chemotherapies, such as cisplatin and paclitaxel, kill rapidly dividing cells, including cancer cells, by interfering with their DNA replication. These treatments are crucial for NSCLC patients as they offer multiple mechanisms to combat the disease, potentially improving outcomes and providing options when conventional therapies fail. The study of new agents like FWD1509 MsOH aims to further enhance these treatment strategies by offering novel mechanisms of action or improved safety and efficacy profiles.

Emerging therapeutic agents for lung cancer.The efficacy of combining antiangiogenic agents with chemotherapy for patients with advanced non-small cell lung cancer who failed first-line chemotherapy: a systematic review and meta-analysis.