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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

FWD1509 Trial Summary

This trial is testing a new cancer drug to see if it is safe and tolerated by patients with advanced lung cancer. They will also establish what the maximum tolerable dose is for this new drug.

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.Check my eligibility
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.See study design
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.

FWD1509 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is at an advanced stage (Stage IIIB/IIIC or IV).
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I have been treated with medication for my advanced or spread cancer.
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I am 18 years old or older.
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I have enough tumor tissue available for testing.
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My organs are working well.
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I am willing and able to follow the study's schedule and procedures.
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I am fully active or restricted in physically strenuous activity but can do light work.

FWD1509 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
22-30 participants with treatment-related adverse events as assessed based on CTCAE v5.0.
Secondary outcome measures
AUC0-24: Area Under the Plasma Concentration versus Time Curve From Time 0 to Time 24h for FWD1509
AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to infinite time for FWD1509 MsOH
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for FWD1509 MsOH
+11 more

FWD1509 Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment of NSCLC patients with EGFR or HER2 genetic alterationsExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

WuXi ClinicalUNKNOWN
1 Previous Clinical Trials
75 Total Patients Enrolled
Forward Pharmaceuticals Co., Ltd.Lead Sponsor
1 Previous Clinical Trials
99 Total Patients Enrolled

Media Library

FWD1509 MsOH (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05068024 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Treatment of NSCLC patients with EGFR or HER2 genetic alterations
Non-Small Cell Lung Cancer Clinical Trial 2023: FWD1509 MsOH Highlights & Side Effects. Trial Name: NCT05068024 — Phase 1 & 2
FWD1509 MsOH (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05068024 — Phase 1 & 2

Frequently Asked Questions

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

How many people are receiving therapy in this experiment?

"That is correct. The clinicaltrials.gov website states that the study is open for recruitment and lists 8/23/2021 as the date when the trial was first posted and 7/20/22 as the date of the most recent edit. Additionally, the site notes that 30 patients are needed at 2 locations."

Answered by AI

Are we still admitting people into this research project?

"The answer is affirmative. The clinical trial in question, which was originally posted on 8/23/2021, as indicated by the data on clinicaltrials.gov, is currently recruiting patients. 30 participants are needed across 2 sites."

Answered by AI
~8 spots leftby Mar 2025