Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel in Lung Cancer

Phase II Study of Neoadjuvant Chemotherapy of Nanoparticle Albumin-bound Paclitaxel Plus Carboplatin/Cisplatin in Stage Ⅱ B and IIIA Non-small Cell Lung Cancer Patients

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02016209

Enrollment

Registered

2013-12-19

Start date

2014-01-31

Completion date

2016-03-31

Last updated

2013-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Brief summary

platinum-based albumin-bound paclitaxel regimen in advanced non-small cell lung cancer (NSCLC) especially in lung squamous cell carcinoma has a better tumor response rate and safety than solvent-based paclitaxel.However, the safety and efficacy is uncertain in neoadjuvant therapy.

Detailed description

The main purpose of this study is to observe the safety and efficacy of platinum-based albumin-bound paclitaxel regimen in the treatment of non-small cell lung cancer (NSCLC) of stage Ⅱ B and IIIA .

Interventions

DRUGnanoparticle albumin-bound paclitaxel

Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel in stage Ⅱ B and IIIA non-small cell lung cancer

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

1.Histological or cytological diagnosis of NSCLC of Stage Ⅱ B and IIIA . 2.18 years or older 3.Performance Status 0 to 2; 4.Appraisable disease; 5.patients can tolerant chemotherapy; 6.Total bilirubin 1.5 x upper limit of normal (ULN); 7.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula).

Exclusion criteria

1.Any systemic anticancer treatment for NSCLC；2.Local radiotherapy for NSCLC；3.In this study within five years prior to the start of treatment with other than NSCLC patients with other cancers.4.Any instability in systemic disease; 5.Allergic to paclitaxel or Platinum;6.Pregnant or lactating women;7.Other researchers believe that does not fit into the group

Design outcomes

Primary

Measure	Time frame
Tumor response rate and Number of Adverse Events	From date of randomization until the date of progression, assessed up to 2 months

Secondary

Measure	Time frame
disease free survival	From date of surgery until the date of first documented progression, assessed up to 36 months

Other

Measure	Time frame
dynamic circulating tumor cell changes during treatment	baseline, 3 weeks and up to progression disease

Countries

China

Contacts

Primary ContactQiong Zhao, PhD

doczq.2008@gmail.com0571-87236802

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026