Clinical trial NCT01336543 (phase 2, status: withdrawn)
Conditions: stage iii non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: chemotherapy following concurrent chemoradiotherapy
SMILES: [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Reason stopped: 
    low accrual, small patient population at center.
  
Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients 18 years and older with histology proven NSCLC with inoperable stage
             III A or IIIB disease.

          2. Inoperable stage III A defined by multiple and or/bulky N2 mediastinal lymph nodes on
             computed tomography (CT) scan such that in opinion of treating investigator, the
             patient was not a candidate for surgical resection.

          3. N2 disease must be documented by either biopsy, fluorodeoxyglucose positron emission
             tomography (PET), and or CT scan if nodes are more than 2 cm.

          4. Stage IIIB patients must have N3 or T4 status. N3 status must be documented by
             presence of contralateral (to the primary tumor) mediastinal lymph node or
             supraclavicular or scalene lymph node proven by either biopsy, fluorodeoxyglucose PET,
             or more than 2 cm on CT scan.

          5. No prior treatment for lung cancer

          6. ECOG Performance status of 0-1.

          7. Initiation of consolidation chemotherapy within 4-8 weeks of concurrent
             chemo-radiotherapy without progression.

          8. Adequate organ function

               -  leukocytes >3,000/mcL

               -  absolute neutrophil count >1,500/mcL

               -  platelets >100,000/mcL

               -  total bilirubin within normal institutional limits

               -  AST (SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal

               -  creatinine within normal institutional limits OR

               -  creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above
                  institutional normal

             All labs should be obtained within 14 days prior to start of study drug treatment.

          9. Ability to give informed consent and willingness to adhere to study protocol.

        Exclusion Criteria:

          1. Patient who have had prior treatment for lung cancer.

          2. Prior history of radiation to chest.

          3. Known malignancy other than the current cancer.

          4. Uncontrolled intercurrent illness including but not limited to ongoing active
             infection, history of cardiac disease, e.g. uncontrolled hypertension, unstable
             angina, congestive heart failure, myocardial infarction within last six months or
             ventricular arrhythmias requiring medication, psychiatric illness that would impair
             patients ability to comply with study requirements.

          5. Pregnant or lactating women (any women becoming pregnant during the study will be
             withdrawn from the study)

          6. Patient with documented or symptoms of peripheral neuropathy.

          7. History of allergic reaction to compounds similar to the ones used in this study.

          8. Malignant effusions (pleural or pericardial)

          9. Superior sulcus (Pancoast) tumors.

         10. Any condition that would hamper ability to give informed consent or ability to comply
             with study protocol.

         11. HIV patients on anti-retroviral therapy are in-eligible to participate in this study
             because of potential interaction with the study drugs and increase susceptibility for
             infections during course of marrow suppressive chemotherapy and radiotherapy.