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This is a prospective, single-center phase II clinical study aimed at evaluating the efficacy and safety of Vebreltinib in neoadjuvant treatment for patients with resectable stage IIA-IIIB (N2) non-small cell lung cancer (NSCLC) with MET exon 14 skipping mutations. In the study, all eligible subjects who signed the informed consent and met the inclusion and exclusion criteria were treated with Vebreltinib (200 mg bid po) for 8 weeks before surgery. The subjects were evaluated by the investigators and the surgical resection was performed within approximately 2 weeks after the neoadjuvant treatment. The study used RECIST v1.1 for imaging assessment. A CT or enhanced CT scan was conducted within 2 weeks after the end of treatment, and then every 180 days (±14) after surgery until 3 years, and then annually until disease recurrence or death, or the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vebreltinib Arm | Experimental | treated with Vebreltinib (200 mg bid po) for 8 weeks before surgery. The subjects were evaluated by the investigators and the surgical resection was performed within approximately 2 weeks after the neoadjuvant treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vebreltinib Enteric Capsules | Drug | treated with Vebreltinib (200 mg bid po) for 8 weeks before surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Major pathologic response (MPR) rate | MPR rate is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants. | Up to 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response (ORR) rate | orr is defined as the proportion of patients who achieve partial response (PR), or complete response (CR) among all patients. | up to 30 months |
| Disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tong Li, PHD | Contact | 86+18813039287 | litong_medical@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Haiquan CHEN, phd | Fudan University Shanghai Cancer Center, Shanghai, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center, Shanghai, | Shanghai | China |
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DCR Rate is defined as the proportion of patients who achieve stable disease (SD), partial response (PR), or complete response (CR) among all patients.
| up to 30 months |
| Pathologic complete response (PCR) rate | PCR rate is defined as the proportion of participants who have achieved pathologic complete response (on routine hematoxylin and eosin staining, no tumor cell can be found in tumor bed or lymph node) in all participants. | Up to 30 months |
| Event-free survival (EFS) | Event-free survival (EFS) is defined as the length of time (months) from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). | up to 60 months |
| 3-year overall survival Rate | OS is defined as the time (months) from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date. | Up to 36 months |
| Overall survival (OS) | OS is defined as the time (months) from enrollment to death of participant due to any cause. In the case of a patient who still survives at the time of analysis, the date of last contact will be taken as the censoring date. | up to 60 months |
| Treatment-related adverse event (TRAE) | TRAE is defined and classified according to NCI-CTCAE v5.0 in all participants. | Up to 30 months |