Starting soon
Phase 3
ASKC202 Plus Limertinib as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC
Condition(s) studied
EGFR Activating MutationNon-Squamous Non-Small Cell Lung Cancer (NSCLC)MET Positive
Investigational drug(s) / intervention(s)
ASKC202: ASKC202 tablets 200 mg QD
ASKC202 placebo: ASKC202 placebo tablets QD
osimertinib placebo: osimertinib placebo tablets QD
osimertinib: osimertinib tablets 80 mg QD
pemetrexed: pemetrexed 500 mg/m² by intravenous infusion on Day 1 of each 21-day cycle
cisplatin or carboplatin: cisplatin 75 mg/m² or carboplatin (AUC 5) by intravenous infusion on Day 1 of each 21-day cycle for up to 4 cycles
Limertinib: limertinib tablets 80 mg BID
limertinib placebo: limertinib placebo tablets BID
Study summary
To evaluate the efficacy and safety of ASKC202 combined with limertinib as the first-line treatment for locally advanced or metastatic NSCLC
Eligibility
Inclusion Criteria:
1. Capable of giving signed informed consent.
2. Male or female, at least 18 years of age at the time of ICF signing.
3. Histologically or cytologically confirmed locally advanced or metastatic non-squamous NSCLC, not amenable to curative surgery or radiotherapy.
4. Patients must have untreated advanced NSCLC not amenable to curative surgery or radiotherapy. Prior adjuvant and neo-adjuvant therapies or definitive radiation/chemoradiation are permitted as long as treatment was completed at least 6 months prior to the development of recurrent disease.
5. The tumor harbors EGFR sensitizing mutation (Ex19Del or L858R).
6. MET protein overexpression as determined by central laboratory testing of tumor tissue samples.
7. At least one measurable lesion as assessed by RECIST v1.1.
8. Have adequate organ functions.
9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
10. Have an estimated life expectancy ≥ 12 weeks.
Exclusion Criteria:
1. Known coexistence of other oncogenic driver gene alterations.
2. Prior therapy with an EGFR inhibitor (Patients who have completed the maximum permitted duration of adjuvant therapy and whose disease progressed or recurred ≥12 months after completion of such therapy are eligible for enrollment) or a c-MET-targeted inhibitor.
3. Receipt of any other investigational agent within 4 weeks prior to the first dose of study treatment.
4. Unresolved toxicity of CTCAE Grade ≥2 severity attributed to prior anti-tumor therapy at the time of first dose of study drug.
5. Patients with symptomatic brain metastases or unstable brain metastases.
6. Presence of leptomeningeal disease, brainstem metastases, or spinal cord compression.
7. Prior or concurrent malignancy other than study disease.
8. Inability to swallow oral medication, or any gastrointestinal disease or condition that may significantly impair the absorption of the study drug.
9. Any other serious or uncontrolled acute or chronic medical condition that, in the investigator's judgment, would render the patient unsuitable for participation in the study.
Primary outcome measure(s)
- Progression-Free Survival (PFS) by BICR — 3 years
Progression-free survival (PFS) using BICR assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).Progression-free survival was defined as the time from date of randomization until the documentation of objective disease progression (PD) or death from any cause (whichever occurred first).
Trial sites (1)
| Facility | City | Region | Status |
| Shanghai East Hospital |
Shanghai |
China |
|
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