A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib (NCT07164170) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib
China86 participantsStarted 2025-10-25
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 range18 Years
SexALL
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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.
✕. Toxicities from prior antitumor therapy have not returned to baseline or stabilized.
✕. Patients with active brain metastases.
✕. The patient currently has active interstitial lung disease.
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.