Stage III non-small-cell lung cancer (NSCLC) is seen in a relatively heterogeneous group of patients with ipsilateral mediastinal (N2) lymph node involvement. The relative roles of different treatment modalities are not clear. The purpose of this study is to evaluate the efficacy and safety of neoadjuvant double-drug chemotherapy containing platinum plus anlotinib hydrochloride in patients with stage III(N2) non-small-cell lung cancer.
This is a prospective, open-label, multi-institutional, positive medicine control of equal rank comparative study of neoadjuvant double-drug chemotherapy with platinum plus anlotinib hydrochloride in stage III(N2) non-small-cell lung cancer.The main purpose of this study was to compare the difference in N2 downgrade rate of lymph node and resectability rate between the experimental and control groups, to evaluate the efficacy of anlotinib hydrochloride, and to observe and evaluate its objective response rate(ORR),Disease-free Survival (DFS)and overall survival(OS).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Anlotinib hydrochloride was given 12mg once daily for two weeks, stop for one week, each 3-week cycle for 2 cycles.
(1)Carboplatin was given dosed to an AUC of 6 i.v. injection on day 1, paclitaxel was given 150 mg/m\^2 i.v. on day 1, every 21 days for 2 cycles.Or(2) Carboplatin was given dosed to an AUC 5 or Cisplatin was given 75 mg/m\^2 ,i.v. on day 1, pemetrexed was given 500 mg/m\^2 i.v. on day 1 for nonsquamous, every 21 days for 2 cycles.Or(3) Cisplatin was given 75 mg/m\^2 i.v. on day 1; docetaxel was given 75 mg/m\^2 i.v. on day 1 ,each 21-day cycle for 2 cycles.
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Lymph node(N2)downstage rate
Lymph node downstage rate is depended on the image or pathology dignosis after surgery,staging from N2 to N1 / N0.
Time frame: 3 months
Objective Response Rate (ORR)
ORR is the number of participants with a Complete Response (CR) and Partial Response (PR) divided by the total number of randomized participants per arm, then multiplied by 100. Response is based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria. Complete Response (CR) was defined as the disappearance of all target lesions. Partial Response (PR) was defined as at least a 30% decrease in sum of longest diameter of target lesions compared to baseline or the complete disappearance of target lesions, with persistence of 1 or more nontarget lesion(s) and no new lesions.
Time frame: 3 months
Resectability rate
Resectability rate was defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
Time frame: Lymph node downstage rate is depended on the pathology dignosis after surgery, an expected average of 8 weeks from randomization.
Pathological complete response (pCR) rate
Pathologic Complete Response Rate is defined as lack of evidence of viable cancer in the surgical specimen at the time of surgery.
Time frame: 3 months
Disease-free Survival (DFS)
The period after curative treatment \[disease eliminated\] when no disease can be detected.From date of randomization until the date of first documented progression, whichever came first, assessed up to 40 months.
Time frame: Every 3 months.
Overall Survival (OS)
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OS was assessed from randomization to death as a result of any cause.
Time frame: 3 years
adverse events(AEs)
Number of participants with perioperative complications.
Time frame: 3 months