Non-Small Cell Lung Cancer(NSCLC)
Conditions
Brief summary
This is a single-arm, exploratory trial to evaluate the efficacy and safety of neoadjuvant WX-0593 in patients with resectable ALK-positive or ROS1- positive non-small cell lung cancer(NSCLC).
Interventions
DRUGWX-0593 Tablets
60 mg of WX-0593 tablets, once daily for 7 days, followed by 180 mg of WX-0593 tablets, once daily in a 28-days cycle.
Sponsors
Pingping Song
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed non-small cell lung cancer (NSCLC). * ALK-positive or ROS1-positive NSCLC in Stage IB-IIIA (according to the 8th American Joint Committee on Cancer TNM edition), as assessed by investigator. * Complete surgical resection of the primary NSCLC must be deemed achievable, as assessed by a MDT evaluation (which should include a thoracic surgeon, specialized in oncologic procedures). * ECOG Performance Status of 0-1. * At least one measurable lesion according to RECIST 1.1. * Adequate organ and marrow function.
Exclusion criteria
* Prior treatment with any systemic anti-cancer therapy for NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug. * Prior treatment with ALK TKI or ROS1 TKI. * Prior treatment with local radiotherapy. * Mixed small cell and NSCLC histology. * Patients who are candidates to undergo only segmentectomies or wedge resections.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Pathologic Response (MPR) Rate | At time of surgery | Major pathologic response (MPR) rate is defined as percentage of residual viable tumor cells histologically detected in the resected primary tumor after surgery ≤10%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resectability rate | At time of surgery | Resectability rate is defined as the percentage of participants who were able to undergo surgery after neoadjuvant therapy. |
| R0 Resection rate | At time of surgery | R0 Resection rate is defined as the percentage of participants who were able to undergo R0 Resection surgery after neoadjuvant therapy. |
| Objective Response Rate (ORR) | Prior to surgery | Objective Response Rate (ORR) is defined as the percentage of participants who have a complete response (CR) or partial response (PR). Responses are according to RECIST 1.1 as assessed by investigator. |
| Pathologic Complete Response (pCR) Rate | At time of surgery | Pathologic complete response (pCR) rate is defined as the percentage of participants with absence of residual tumor in lung and lymph nodes. |
| Event-free survival (EFS) | 3 years postoperatively | Event-free survival (EFS) is the length of time after initial administration the participant remains free of recurrence/progression or death, whatever the cause. |
| Disease-free survival (DFS) | 3 years postoperatively | Disease-free survival (DFS) is the length of time after surgical resection the participant remains free of recurrence/progression or death, whatever the cause. |
| Overall Survival (OS) | 3 years postoperatively | Overall Survival (OS) is the length of time after initial administration the participant remains alive. |
| Disease Control Rate (DCR) | Prior to surgery | Disease Control Rate (DCR) is defined as the percentage of participants who have a best overall response of CR, PR, or stable disease (SD). Responses are according to RECIST 1.1 as assessed by investigator. |
Countries
China
Contacts
Primary ContactPingping Song
Backup ContactGuodong Zhang
Outcome results
None listed