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

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Western Regional Medical Center
• Treatments: Cisplatin; Gemcitabine; Pemetrexed

Criteria

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