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BDTX-1535 + Temozolomide for Glioblastoma and Lung Cancer
Study Summary
This trial is testing a new drug for people with glioblastoma or non-small cell lung cancer who have disease progression following standard of care.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 2 trial • 175 Patients • NCT01055314Trial Design
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Who is running the clinical trial?
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- I need urgent treatment for brain or spinal cord issues due to cancer.I am currently receiving or have recently received cancer treatment.For the initial phase, participants must have a disease that can be evaluated. In the later phase, only participants with a measurable disease can join.My lung cancer is non-small cell type without any small cell transformation.I have symptoms or imaging results showing disease in the lining of my brain and spinal cord.I have recovered from major surgery to remove as much cancer as possible.My cancer has returned after surgery, radiation, or chemotherapy.My cancer has mutations known to resist treatment.I have been diagnosed with glioblastoma multiforme (GBM).I had radiation and temozolomide treatment 6-8 weeks ago.Meets the specific disease criteria described in the study's arms and interventions.I do not have active hepatitis B or C, nor am I an HIV carrier.My condition worsened after or I couldn't tolerate standard treatment.I have been treated with an EGFR inhibitor for my brain cancer.My bone marrow and organs are functioning well.My cancer has spread beyond its original location, possibly to my brain.My tumor has EGFR alterations.I have no lasting side effects from previous treatments.I have a serious heart condition.I am currently undergoing or have recently completed radiation therapy.I have not had major surgery in the last 4 weeks and do not plan any during the study.My condition worsened after treatment or I cannot tolerate the treatment.I don't need treatment for any other cancer within 2 years.I have severe stomach or bowel problems that are not well-managed.You are expected to live for at least 3 more months.
- Group 1: Phase 2 Cohort 1: NSCLC EGFR Non-Classical Driver Mutations
- Group 2: Phase 2 Cohort 2: NSCLC EGFR Acquired Resistance (C797S) Mutation
- Group 3: Phase 2 Cohort 3: Treatment Naive NSCLC EGFR Non-Classical Driver Mutations
- Group 4: Phase 1 Dose Escalation - Monotherapy (Recruitment Closed)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How widely dispersed is the current trial?
"The recruitment for this study is underway at 10 separate sites, including those located in Greenville, New york, and Nashville. Due to the necessity of follow-up visits it may be beneficial to choose a location close by when enrolling."
Has the FDA sanctioned BDTX-1535 Monotherapy?
"Due to the dearth of evidence for safety and efficacy, BDTX-1535 Monotherapy has been rated a 1 on our assessment scale. This is in line with it being a Phase 1 trial."
Are there any openings left for participants in this experiment?
"This medical endeavour, which was initially posted on March 31st 2022, is still recruiting participants as indicated by clinicaltrials.gov with the most recent update being released November 9th 2022."
In what numbers are participants engaging in this clinical experiment?
"For this study to be a success, 90 qualified participants are needed. Patients interested in taking part can register at either 1013 Greenville (South carolina) or 1001 New york City (New York)."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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