A Study of Neoadjuvant Chemotherapy Plus Anlotinib in Stage III(N2) Non-small-cell Lung Cancer

NCT04181372 | Unknown Phase 2

• 1 other identifier: NSCLC 001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stage III Non-small-cell Lung Cancer

Keywords

Stage III Non-small-cell Lung Cancer; Anlotinib Hydrochloride; Neoadjuvant

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  3 months

• Resectability rate

  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

  3 months

• Disease-free Survival （DFS）

  Every 3 months.

• Overall Survival (OS)

  3 years

Study Arms (2)

Anlotinib plus Platinum-based chemotherapy

EXPERIMENTAL

1. Take anlotinib hydrochloride 12mg once daily for two weeks, stop for one week, the program repeats every 21 days for 2 cycles. 2. Platinum-based chemotherapy regimens for neoadjuvant:(1)Carboplatin was given dosed to an area under the serum concentration-time curve (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.

Drug: Anlotinib hydrochloride

platinum-based chemotherapy

ACTIVE COMPARATOR

Platinum-based chemotherapy regimens for neoadjuvant:(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.

Drug: platinum-based chemotherapy medicine

Interventions

Anlotinib hydrochloride DRUG

Anlotinib hydrochloride was given 12mg once daily for two weeks, stop for one week, each 3-week cycle for 2 cycles.

Also known as: AL3818

Anlotinib plus Platinum-based chemotherapy

platinum-based chemotherapy medicine DRUG

(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.

platinum-based chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age :18 Years to 75 Years (Adult, Older Adult)
• Pathological diagnosis with Stage III-N2 NSCLC which is clinically resectable and the N2 is diagnosed by either mediastinoscopy,EBUS,PET/CT;
• EGFR、ALK、ROS1 mutation-negative；Patients with squamous cell carcinoma may not have genetic testing;PD-L1\<5%;
• According to the RECIST 1.1 standard, there is at least one measurable target lesion;
• ECOG physical score 0-1 points; expected survival time ≥ 3 months;
• The main organ function meets the following criteria:1)blood routine: absolute value of neutrophils ≥ 1.5 × 109 / L, platelets ≥ 75 × 109 / L, hemoglobin ≥ 80 g / L;2)Blood biochemistry: total bilirubin ≤ 1.5 times the upper limit of normal value, aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit of normal value (if liver metastasis, ≤ upper limit of normal value 5 times), serum creatinine ≤ 1.5 times the upper limit of normal;
• Subjects voluntarily joined the study and signed informed consent, with good adherence and follow-up.

You may not qualify if:

• Stage I, II , IV orNSCLC;
• Small cell lung cancer (including lung cancer mixed with small cell lung cancer and non-small cell lung cancer);central lung squamous carcinoma along with cavum;
• Patients with contraindication of chemotherapy
• Subjects who have previously used Anlotinib;
• Systematic anti-tumor treatments have been performed for the past 2 weeks, including chemotherapy, radiotherapy (except for metastatic lesions other than thoracic radiation), targeted therapy, immunotherapy, and biotherapy;
• Imaging (CT or MRI) shows that the distance between tumor lesion and the large blood vessel is ≤ 5 mm, or there is a central tumor that invades the local large blood vessel; or there is a significant pulmonary cavity or necrotizing tumor;
• A history of active bleeding within the first 6 months of screening, or receiving thrombolysis or anticoagulant therapy, or the investigator believes that there is a clear tendency to gastrointestinal bleeding (such as esophageal varices with bleeding risk, local activity) Ulcer lesions, etc.) or active hemoptysis;
• A thrombotic event occurs within 6 months (including arteriovenous thrombosis, pulmonary embolism, cerebrovascular accident, including transient ischemic attack, etc.);
• Cardiac diseases with obvious clinical symptoms, such as: congestive heart failure, coronary heart disease with obvious symptoms, arrhythmia with difficult drug control (including clinically significant QTc interval prolongation history, or screening period QTc interval women \>470ms, Male \> 450ms), had myocardial infarction within 6 months, or cardiac insufficiency;
• Hypertension, which is uncontrolled by the drug, is defined as: systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg;
• Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or patients with total gastrectomy;
• Surgery (\<28 days) before the study was selected or the surgical incision did not completely heal, or there were other unhealed wounds;
• Active or uncontrolled serious infections;
• Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures;

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 457, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

anlotinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jiexia Zhang, prof.

  The First Affiliated Hospital of Guangzhou Medical University

  STUDY CHAIR

Central Study Contacts

Jiexia Zhang, prof.

CONTACT

+8613903056432; drzjxcn@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: November 29, 2019
• Study Start: December 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2022
• Last Updated: November 29, 2019

Record last verified: 2019-11

Locations

CN (1)