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New treatment option for Non-Small Cell Lung Cancer
Official title A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib
ClinicalTrials.gov ID: NCT07164170
What this study is testing
What is ABSK043 in combination with Glecirasib?
ABSK043 in combination with Glecirasib is an investigational medicine, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Prior to any protocol- specific procedures are performed, the patient should understand and voluntarily sign and date the written informed consent...
- 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). For patients in the...
- 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%) . For patients in the expansion cohort of...
You likely can't join if
- 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.
- Patients currently have active autoimmune disease or a history of autoimmune disease that may be at risk for recurrence.
- Any condition requiring systemic treatment with corticosteroids.
See the full eligibility 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). For patients in the dose-escalation cohort (Part A) of the escalation part: Patients must have...
- 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%) . For patients in the expansion cohort of the expansion part :
- 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.
- Patients must have at least one measurable lesion as defined by RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1.
- Expected survival time of ≥3 months.
- Patients must have adequate organ and bone marrow function.
- 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.
- Patients currently have active autoimmune disease or a history of autoimmune disease that may be at risk for recurrence.
- Any condition requiring systemic treatment with corticosteroids.
- Uncontrolled or significant cardiovascular disease.
- Has a known human immunodeficiency virus (HIV) infection that is not well controlled.
- Any evidence of severe or uncontrolled diseases or other factors which in the Investigator's opinion makes it undesirable for the patients to participate in the study
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Guangzhou, Guangdong, China
- Nanning, Guangxi, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Nanjing, Jiangsu, China
- Shenyang, Liaoning, China
- Jinan, Shangdong, China
- Shanghai, Shanghai Municipality, China
- Xi’an, Shanxi, China
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Guangzhou, Guangdong, China; Nanning, Guangxi, China; Harbin, Heilongjiang, China and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.