A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib (NCT07164170) | Clinical Trial Compass
RecruitingPhase 2
A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib
China86 participantsStarted 2025-09-22
Plain-language summary
This is a multicenter, open-label phase 2 study that will enroll KRASG12C mutated patients with locally advanced or metastatic NSCLC, receiving treatment (ABSK043 in combination with Glecirasib) in a 21-day combination cycle.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Prior to any protocol- specific procedures are performed, the patient should understand and voluntarily sign and date the written informed consent form.
. Gender was not limited patients aged ≥18 years at the time of signing the informed consent.
. Histologically or cytologically confirmed locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC).
. Prior treatment requirements for patients in cohort (Part B) are the same as those for patients in (Part A);
. Documented or central laboratory test report confirmed that the tumor was PD-L1 expression positive (≥1%) .
. Patients who have not received prior systemic therapy for locally advanced or unresectable/metastatic disease;
. Central laboratory test report confirmed that the tumor was PD-L1 expression positive (≥1%) .
. Tumor tissue or blood test report confirmed KRASG12C mutation.
Exclusion criteria
. Histological or cytological evidence of small cell lung cancer or neuroendocrine carcinoma components.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of DLT
Timeframe: At the end of Cycle 1 (each cycle is 21 days)
2
AEs
Timeframe: From the time the patient signs the informed consent form throughout the study and up to 90 days after the last dose of ABSK043 or 30 days after the last dose of Glecirasib, whichever occurs first, up to 30 months.
3
SAEs
Timeframe: From the time the patient signs the informed consent form throughout the study and up to 90 days after the last dose of ABSK043 or 30 days after the last dose of Glecirasib, whichever occurs first, up to 30 months.
4
AESIs AESIs
Timeframe: From the time the patient signs the informed consent form throughout the study and up to 90 days after the last dose of ABSK043 or 30 days after the last dose of Glecirasib, whichever occurs first, up to 30 months.
5
ORR
Timeframe: From date of enrolment#Cycle1 Day1# until disease progression, death, loss to follow-up, withdrawal of consent, intolerable toxicity, investigator's decision to discontinue treatment, or end of study, whichever comes first, assessed up to 50 months.