Resectable Lung Non-Small Cell Carcinoma
Conditions
Brief summary
This is a prospective, multicenter, randomized, uncontrolled Phase II study to assess the efficacy and safety of adebrelimab in combination with chemotherapy with or without bevacizumab for the treatment of resectable Stage II-IIIB (T3N2) NSQ-NSCLC and to explore biomarkers associated with efficacy.
Detailed description
Neoadjuvant therapy with experimental treatment followed by surgery.
Interventions
DRUGAdebellizumab
adebrelimab
DRUGBevacizumab
bevacizumab
paclitaxel or albuminotaxol or docetaxel combined with platinum, pemetrexed combined with platinum. Platinums include carboplatin, cisplatin and nedaplatin.
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Resectable NSQ NSCLC * Age 18-65 years * male or female * ECOG 0-1 * Subjects have not received surgery, chemotherapy, radiotherapy and biological treatment of treatment-naive non-squamous non-small cell lung cancer * Subjects must have adequate pulmonary function for the intended pneumonectomy;
Exclusion criteria
* SCLC or SQ NSCLC * previously used anti-PD1, anti-PDL1, anti-CTLA4 antibodies, etc. * patients who have previously used anti-angiogenic drugs; * allergic to any component of the study drug or chemotherapy drugs * patients with any severe and or uncontrolled disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response | After 4 cycles of neoadjuvant therapy(3 weeks per cycle), surgical resection was performed at intervals of 4-6 weeks. Pathological response assessment results were assessed within one week after surgery. | Pathological complete response, pCR (primary tumor + lymph nodes).It refers to the proportion of subjects with no residual surviving tumor cells (including lymph nodes) in the postoperative specimen among the enrolled subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Pathological response | After 4 cycles of neoadjuvant therapy(3 weeks per cycle), surgical resection was performed at intervals of 4-6 weeks. Pathological response assessment results were assessed within one week after surgery. | It refers to the proportion of subjects with residual surviving tumor cells of ≤ 10% in the postoperative specimen among the enrolled subjects. |
| Overall response rate | After 4 cycles of neoadjuvant therapy(3 weeks per cycle), before surgical resection was performed（at intervals of 4-6 weeks）. | It refers to the proportion of patients whose tumor shrinks to a certain extent and maintains it for a certain period of time, including CR and PR cases. |
| event free survival | from randomization to imaging confirmation, local progression leading to inoperable tumors, unresectable tumors, local or distant recurrence, and death from any cause, whichever came first, assessed up to 24 months. | Defined as disease progression from randomization to imaging confirmation, local progression leading to inoperable tumors, unresectable tumors, local or distant recurrence, and death from any cause. |
| safety | Safety follow-up will be conducted 30 ± 7 days after the last use of bevacizumab/chemotherapy or 90 ± 7 days after the last use of adebrelimab/surgery (whichever occurs later) to track the relief of AE. Incidence of AE/SAE/TRAE will be recorded. | Monitoring and recording of adverse events, including Incidence of serious adverse events and adverse events of special interest. |
Countries
China
Contacts
Primary ContactJianxing He
Outcome results
None listed