Neoadjuvant Chemo for Non-metastatic Non-small Cell Lung Cancer
Condition: Non-squamous Cell Non-Metastatic Non-Small Cell Lung Cancer; Squamous Cell Non-Metastatic Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Cisplatin; Pemetrexed; Gemcitabine
Intervention description: Alkylating antineoplastic agent (Chemotherapy); Antimetabolite antineoplastic agent (Chemotherapy); Antimetabolite antineoplastic agent (Chemotherapy)
Intervention MeSH terms: Gemcitabine; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility 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