NSCLC (Non-small Cell Lung Cancer)
Conditions
Brief summary
This is a multicenter, randomized, open-label, phase 3 clinical trial designed to evaluate the efficacy and safety of JMKX001899 compared to docetaxel in patients with previously treated, KRAS G12C-mutant advanced or metastatic non-small cell lung cancer (NSCLC). KRAS G12C mutation is present in a subset of NSCLC patients. While docetaxel is a standard chemotherapy option, JMKX001899 is an investigational, targeted therapy designed to selectively inhibit the KRAS G12C mutation. This trial aims to determine whether JMKX001899 offers a superior clinical benefit compared to standard chemotherapy.
Interventions
DRUGJMKX001899
Orally, once daily
DRUGDocetaxel
By IV infusion every 21 days
Sponsors
Jemincare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years. 2. Histologically or cytologically confirmed NSCLC. 3. Failure of at least one prior line of therapy for locally advanced/metastatic disease, that included a platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. 4. At least one measurable lesion as defined by RECIST version 1.1.
Exclusion criteria
1. Known concomitant presence of other oncogenic driver mutations or rearrangements with established targeted therapies . 2. Previous treatment with any KRAS G12C-targeted agent. 3. Prior docetaxel therapy in the locally advanced/metastatic setting.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 1 year | Progression-Free Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 3 years | Overall Survival |
| AE | from first dose to 28 days after the last dose | Adverse Event |
Countries
China
Contacts
Primary ContactFawei Wu
Outcome results
None listed