JIN-A02 for EGFR Mutant Advanced Non-small Cell Lung Cancer
This study is testing a new oral drug called JIN-A02 for people with advanced non-small cell lung cancer (NSCLC) that has specific changes (mutations) in the EGFR gene. You might be able to join if your cancer has progressed after standard treatments, including other EGFR-targeted therapies or platinum-based chemotherapy. The main goals are to find the safest and most effective dose of JIN-A02 and to understand any side effects. Researchers will also look at how the drug moves through your body and if it helps shrink tumors. This study is currently recruiting about 150 participants.
- Study design
- This is an open-label study, meaning you and your doctors will know you are receiving JIN-A02. It is a Phase 1/2 study, starting with a dose-escalation phase to find the maximum tolerated dose.
- What's involved
- JIN-A02 is taken by mouth once a day, with each treatment cycle lasting 28 days. The study will monitor for side effects for at least 21 days after you start treatment.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess side effects and the maximum tolerated dose within 28 days of starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Phase 1/2 Study to Evaluate the Safety, Tolerability and PK of JIN-A02 in Patients With EGFR Mutant Advanced NSCLC
At a glance
Conditions
Where it's being run
10 sites across 5 statesStudy leadership
- Ethan Seah · STUDY_DIRECTOR · J Ints Bio
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Maximum Tolerable Dose (MTD)28 days
In the Part A dose escalation study, MTD is evaluated in DLT Set. When the study ends according to the BOIN design, the DLT rate per dose level is estimated as posterior probability based on the beta-binomial model and 95% CI is presented. The dose level at which the estimated DLT rate is closest to the target toxicity rate 0.3 is selected as MTD. If two or more dose levels are selected at a rate lower than 0.3, a higher one is selected as MTD. If two or more dose levels are selected at a rate higher than 0.3, a lower one is selected as MTD.
- Adverse Events (AE) rate28 days
Safety evaluation is analyzed based on the Safety Set. Safety is clinically evaluated by assessing all relevant endpoints, including AE, SAE, laboratory tests, vital signs, ECG results and concomitant drugs. Reported AE terminologies are standardized using MedDRA and the AE grade and intensity are evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. The AE summary focuses on AE that first occurred after initial administration of IP or that occurred after administration as an aggravation of pre-existing symptoms. AEs are summarized by the number and percentage of subjects experiencing AE per cohort based on the System Organ Class (SOC) and Preferred Term (PT).
- Serious Adverse Events (SAE) rate28 days
Safety evaluation is analyzed based on the Safety Set. Safety is clinically evaluated by assessing all relevant endpoints, including AE, SAE, laboratory tests, vital signs, ECG results and concomitant drugs. Reported AE terminologies are standardized using MedDRA and the AE grade and intensity are evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. The AE summary focuses on AE that first occurred after initial administration of IP or that occurred after administration as an aggravation of pre-existing symptoms. AEs are summarized by the number and percentage of subjects experiencing AE per cohort based on the System Organ Class (SOC) and Preferred Term (PT).
- Dose Limiting Toxicity (DLT)21 days
DLT is evaluated for all subjects enrolled to cycle 1 (DLT evaluation period: 21 days) of the Part A dose escalation study. When a subject receives at least 75% of his or her assigned daily dose during the DLT period or shows DLT, the subject is considered evaluable for DLT. All AEs that occur during the DLT period, are possibly related to JIN-A02 in the least and satisfy all of the following criteria are designated as DLT. Also, the occurrence of any of the toxicities outlined in this section will be considered a DLT unless clearly related to underlying disease or extraneous causes.