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APL-101 for Lung Cancer (SPARTA Trial)
SPARTA Trial Summary
This trial is testing a new drug to see if it is safe and effective for people with different types of cancer.
SPARTA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSPARTA Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SPARTA Trial Design
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Who is running the clinical trial?
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- I am 18 years old or older.I have brain or spinal cord disease that doesn’t cause symptoms.My organs are functioning well.I currently have an active COVID-19 infection.You are expected to live for at least 3 months from the start of the study.I have hepatitis or HIV but am not stable on medication, or I am stable with HIV and meet specific health criteria.I cannot swallow pills whole.I had cancer before, but it was a type unlikely to come back within 3 years.My cancer has a specific change in genes like EGFR, ALK, etc., except if I'm in Cohort C or C-2 for NSCLC.I can provide a biopsy sample for the study, or I already have approved test results.I do not have any severe illnesses or conditions that could affect my safety or the study results.I have stable brain metastases and haven't increased my steroid dose in the last 2 weeks.My heart is functioning well.I am not pregnant, surgically sterile, or post-menopausal.I haven't had a recent heart attack or unstable heart issues, and I'm not on medication that affects my heart rhythm.I have a digestive condition that affects how medicines work in my body.I can stop taking certain medications that may interfere with the study drug.I can care for myself and perform daily activities, or if I have a brain tumor, my health status allows me to live a normal life.I do not have any major surgeries planned within the next 4 weeks.You are allergic to APL-101 or any other ingredients in the study treatment.I do not have any active, uncontrolled infections or other serious health conditions.I have at least one tumor that can be measured on a scan taken within the last 28 days.
- Group 1: Primary CNS tumors with MET alterations
- Group 2: Basket of solid tumor with MET gene fusions except for primary CNS tumors
- Group 3: NSCLC Exon 14 Skip Treatment Naive
- Group 4: NSCLC Exon 14 Skip Previously Treated
- Group 5: NSCLC Exon 14 MET Inhibitor Experienced
- Group 6: Basket of tumor types MET amplification except for primary CNS tumors
- Group 7: Basket of tumor types wild-type MET with over-expression of HGF and MET
- Group 8: NSCLC MET amplification and EGFR wild-type
- Group 9: EGFR positive NSCLC MET amplification as an acquired resistance
- 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
Are we still able to add patients' names to the study?
"Yes, this study is still looking for participants and has not yet reached its target sample size. The trial was initially posted on September 27th, 2017 with the most recent update occurring on July 26th, 2022."
Are many hospitals conducting this research within the US?
"To make participation more convenient for enrollees, this trial is being conducted at 42 sites. Some of these locations are in New Orleans, Kettering and Tacoma with the remaining 38 located elsewhere."
How many people are enrolled in this trial?
"The sponsor, Apollomics Inc., needs to recruit 344 patients that fit the bill in order to commence this study. Multiple sites will be used including Ochsner Clinic Foundation and Kettering Health Network."
What are we hoping to learn from this clinical trial?
"The main goal of this clinical trial is to assess the maximum tolerated dose (MTD) and incidence of DLTs over a period of 28 days. Secondary objectives include evaluating antitumor activity, median time to progression, and median duration of response."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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