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Neoadjuvant Chemotherapy for Non-metastatic Non-small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer, Squamous Cell Non-Metastatic Non-Small Cell Lung Cancer

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Trial Information

Neoadjuvant Chemotherapy for Non-metastatic Non-small Cell Lung Cancer


Inclusion Criteria:



1. Patients ≥ 18 years of age with either a mass suspicious for or histologically
confirmed AJCC stage IB-IIIA NSCLC. For those without histologic confirmation of
NSCLC, a biopsy will be done and only those patients with histologically confirmed
NSCLC meeting all other eligibility criteria may proceed on protocol.

2. Mass must be determined to be surgically resectable

3. Eastern Cooperative Oncology Group (ECOG) performance status score < 1 and a life
expectancy >3 months.

4. Participants must have at least one evaluable lesion as defined by RECIST 1.1

5. Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5
g/dL

6. Serum creatinine ≤1.3 mg/dL (candidate for cisplatin chemotherapy), total bilirubin ≤
2 mg/dL, AST/ALT ≤ 5 times the upper limit of normal range

7. No prior chemotherapy or radiotherapy for NSCLC

8. At least 5 years from diagnosis of another cancer except treated in-situ disease or
surgically resected non-melanoma skin cancer with clear margins.

9. Willingness to provide permission to biopsy NSCLC for collection of frozen
pretreatment sample.

10. Women of child-bearing potential (i.e., women who are pre-menopausal or not
surgically sterile) must be willing to use an acceptable contraceptive method
(abstinence, oral contraceptive or double barrier method) for the duration of the
study and for 30 days following the last dose of study drug, and must have a negative
urine or serum pregnancy test within 2 weeks prior to beginning treatment on this
trial

Exclusion Criteria:

1. Active clinically serious infection > CTCAE (version 4.03) Grade 2.

2. Serious non-healing wound, ulcer, or bone fracture.

3. Major contraindication to surgical resection of NSCLC

4. Inability to complete informed consent process and adhere to the protocol treatment
plan and follow-up requirements.

5. Concurrent severe illness such as active infection, or psychiatric illness/social
situations that would limit safety and compliance with study requirements.

6. Patients receiving any other investigational agents.

7. Pregnant or lactating females

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of pathologic complete responses (pCR) at the time of definitive surgical resection of non-small cell lung cancer

Outcome Description:

Determine the rate of pathologic complete responses (pCR) at the time of definitive surgical resection of non-small cell lung cancer (NSCLC)

Outcome Time Frame:

One year

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

13-04

NCT ID:

NCT01860040

Start Date:

April 2013

Completion Date:

April 2015

Related Keywords:

  • Non-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer
  • Squamous Cell Non-Metastatic Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Western Regional Medical CenterGoodyear, Arizona  85338