JAB-21822 Combined with JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer with KRAS P.G12C Mutation

Launched by ALLIST PHARMACEUTICALS, INC. · May 14, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment combination called JAB-21822 and JAB-3312 for patients with advanced non-small cell lung cancer (NSCLC) that has a specific mutation known as KRAS p.G12C. The goal is to see how well this new treatment works compared to the standard treatment, which includes a drug called tislelizumab along with two others called pemetrexed and carboplatin. The trial is currently looking for participants aged 18 and older who have been diagnosed with this type of lung cancer and have not received previous treatment for their advanced disease.

To be eligible for this trial, participants should have a confirmed diagnosis of locally advanced or metastatic non-squamous NSCLC with the KRAS p.G12C mutation. They should also expect to live for at least three more months and have a specific level of health as measured by the Eastern Cooperative Oncology Group (ECOG) scale. Participants will need to provide consent before starting the study and will undergo regular assessments to monitor their health and the effectiveness of the treatment. It's important to note that individuals with certain other health conditions or types of cancer may not qualify for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • A signed written informed consent is required before performing any study-related operations
• • Age greater than or equal to 18 years old
• • Histologically or cytologically confirmed locally advanced/metastatic, unresectable non-squamous NSCLC with KRAS p. G12C mutation confirmed by the central lab
• • No history of systemic anticancer therapy to the local advanced/metastatic disease
• • Expected survival period greater than or equal to 3 months
• • Having at least one target lesion according to RECIST 1.1
• • Eastern Cooperative Oncology Group (ECOG) ≤ 1
• Exclusion Criteria:
• • Previous (≤2 years) or current solid tumors or hematologic tumors of other pathological types
• • Carry other driver gene mutations with available target therapy, or carry other KRAS mutations
• • Subjects with untreated central nervous system (CNS) metastases were excluded;
• • Uncontrolled pleural effusion, pericardial effusion, and ascites
• • Subjects with impaired heart function or clinically significant heart disease

Trial Officials