Nab-Paclitaxel Versus Paclitaxel Plus Carboplatin in Advanced Squamous Cell Non Small Cell Lung Cancer

NCT03262948 | Unknown Phase 3

• 1 other identifier: NABP201706
• Study Type: interventional
• Target: 388
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, multicenter, open, controlled phase III trial. 388 subjects with stage IIIB who were not eligible for radical surgery or radiotherapy, stage IV or recurrent squamous cell NSCLC were enrolled in this study .The subjects will be randomly assigned to one of the two treatment groups at a 1: 1 ratio, and stratified by sex, ECOG physical status, smoking status, disease staging.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• overall respond rate

  the rate of CR and PR

  overall respond rate will be evaluated every 6 weeks until progression or new anti-cancer therapy initiation, up to 22 months.

Secondary Outcomes (3)

• PFS

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months

• os

  From date of randomization until the date of death from any cause,assessed up to 18 months

• Quality of life assessment

  It will be assessed before the administration of drugs at each first day of the chemotherapy cycle,up to 6 cycles,each cycle is 21 days.

Study Arms (2)

nab-paclitaxel plus carboplatin

EXPERIMENTAL

nab-paclitaxel 260mg/m2,i.v., plus carboplatin AUC = 6,i.v., starting from randomization, once every 3 weeks, for 4-6 cycles, or progression, or intolerance,or death or start a new anti-tumor treatment, whichever occurs first.

Drug: nab-paclitaxel; Drug: Carboplatin

Paclitaxel plus carboplatin

ACTIVE COMPARATOR

paclitaxel 175 mg/m2,i.v., plus carboplatin AUC = 6,i.v., starting from randomization, once every 3 weeks, for 4-6 cycles, or progression, or intolerance,or death or start a new anti-tumor treatment, whichever occurs first.

Drug: Paclitaxel; Drug: Carboplatin

Interventions

nab-paclitaxel DRUG

albumin-bound paclitaxel is 260 mg/m2 intravenously over 30 minutes on Days 1 of each 21-day cycle cycle immediately after albumin-bound paclitaxel

Also known as: keaili

nab-paclitaxel plus carboplatin

Paclitaxel DRUG

paclitaxel is 175 mg/m2 intravenously over 3 hours on Days 1 of each 21-day cycle cycle immediately after paclitaxel

Also known as: aosu

Paclitaxel plus carboplatin

Carboplatin DRUG

carboplatin is administered on Day 1 of each 21-day，followed by paclitaxel or nab-paclitaxel

Also known as: bobei

Paclitaxel plus carboplatin; nab-paclitaxel plus carboplatin

Eligibility Criteria

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

You may qualify if:

• Accepted the purpose of the trial, the contents , the predicted efficacy, pharmacological effects and the full explanation of the risk and was understood that the subject had signed the informed consent.
• Subjects had histopathologically or cytologically confirmed NSCLC type of squamous cell carcinoma and were documented; (must be provided without radiotherapy, fixed with formalin, paraffin At least 5 sheets of tumor tissue after embedding)
• Subjects were IIIB who were not suitable for radical surgery or radiotherapy, IV or recurrent NSCLC ; (according to the 7th edition of the International Lung Cancer Research Council (IASLC) classification)
• Subjects who were palliative radiotherapy for bone lesions other than the chest were given the study drug according to CTCAE 4.03 toxicity ≤1
• at least one measurable objective lesions according to RECIST1.1 standard
• ECOG score ≤ 1
• Expected survival time ≥ 3 months
• Subjects are well-behaved, able to undergo treatment and follow-up, and voluntarily comply with this study
• ≥ 18 years old male and female
• The childbearing age subjects must agree to take effective contraceptive measures during the trial; the serum or urine pregnancy test must be negative before 24 hours of the start of chemotherapy
• Women must be non-lactating

You may not qualify if:

• There is brain metastases;
• The investigators believe that uncontrolled serious medical illnesses that affect the ability of subjects to receive research programs, such as severe medical illnesses, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, Uncontrolled infections, active peptic ulcers;
• Will hinder the understanding or make informed consent or fill in the questionnaire of dementia, mental state changes or any mental illness;
• Any history of allergic or hypersensitivity to any treatment ingredient;
• In the first 5 years of randomization, there were malignant tumors other than NSCLC, except for the treatment of basal cells or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ
• Previously received treatment for advanced/metastatic NSCLC. Note: Allow chemotherapy and radiotherapy to be used as part of neoadjuvant/adjuvant therapy as long as the treatment has ended at least 12 months before the diagnosis of advanced or metastatic disease.
• Received a taxane-based regimen as a neoadjuvant/adjuvant therapy for squamous cell carcinoma ;
• Subjects with ≥2 grade peripheral neuropathy according to CTCAE V 4.03;
• Physical examination and laboratory test results are abnormal ANC：\<1.5×109 / L； PLT：\<100×109/L； Hb: \<90g/L
• Abnormal liver function is defined as:
• I) total bilirubin (TBil) level:\> normal upper limit (ULN) 1.5 times; II) 2.5 times the rate of aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\> ULN, and\> 5 times ULN if liver metastases are present
• Definition of renal dysfunction:
• Serum creatinine\> ULN 1.5 times, or creatinine clearance \<50ml/min
• Coagulation function abnormal definition:
• International Standardization Ratio (INR)\> 1.5 times the ULN, and prothrombin time (PT) or activated partial coagulation Blood enzyme time (aPTT)\> ULN 1.5 times, unless the subject is receiving anticoagulant therapy

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Related Publications (1)

• Socinski MA, Bondarenko I, Karaseva NA, Makhson AM, Vynnychenko I, Okamoto I, Hon JK, Hirsh V, Bhar P, Zhang H, Iglesias JL, Renschler MF. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012 Jun 10;30(17):2055-62. doi: 10.1200/JCO.2011.39.5848. Epub 2012 Apr 30.

  PMID: 22547591 RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

130-nm albumin-bound paclitaxel; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• li zhang, doctor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yumei wang, docter

CONTACT

+86 0311-67808816; wyumei73@mail.ecspc.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 28, 2017
• Study Start: December 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2020
• Last Updated: November 13, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share