Clinical trial NCT02607423 (phase 2, status: withdrawn)
Conditions: stage iiia non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: cisplatin, docetaxel, gemcitabine hydrochloride, pemetrexed disodium
SMILES: [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, NC1=NC(=O)N(C=C1)[C@@H]1O[C@H](CO)[C@@H](O)C1(F)F, [H][C@@](CCC(O)=O)(NC(=O)C1=CC=C(CCC2=CNC3=C2C(O)=NC(=N)N3)C=C1)C(O)=O
Reason stopped: 
    the study failed to meet its accrual targets.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have stage IIIA non-small cell lung cancer (T1-3N2) per American Joint
             Committee on Cancer (AJCC) 7th edition and must be considered to be surgically
             resectable

          -  Patients must be assessed by surgeons and are considered surgically resectable

          -  Mediastinal nodal metastases (N2) disease must be confirmed histologically

          -  Easter Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Required imaging studies obtained within four weeks prior to registration

          -  White blood cell (WBC) >= 4000 mm^3 or granulocyte count at least 2,000/mm^3

          -  Platelets >= 100,000/mm^3

          -  Hemoglobin >= 10.0g/dL

          -  Total bilirubin < 1.5 mg/dL

          -  Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) < 3
             x upper limit of normal (ULN)

          -  Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x
             ULN

          -  Alkaline phosphatase < 3 x ULN

          -  Calculated/estimated or measured creatinine clearance at least 50 ml/min; note:
             creatinine clearance should be calculated using the Cockcroft-Gault formula; patients
             who will receive pemetrexed/cisplatin therapy must be obtained within 2 weeks of
             registration

          -  Patients cannot have hormonal cancer therapy or radiation therapy as prior cancer
             treatment within 5 years of registration; (prior surgery, biologic therapy, hormonal
             therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that
             is not considered cured is acceptable)

          -  Patients must not have any history of other cancer within 5 years from registration
             with the exception of in situ carcinoma of the cervix, in situ carcinoma of the breast
             or completely resected non-melanoma skin cancer

          -  Patients may not have received prior chemotherapy or radiation therapy for lung cancer

          -  Patients with a history of myocardial infarction are eligible if the event occurred >
             6 months prior to entry

          -  Patients must not have any clinically significant ongoing, active or serious
             infection, symptomatic or uncontrolled congestive heart failure, active angina,
             symptomatic or uncontrolled cardiac arrhythmia or any other medical condition or
             psychiatric illness/social situations that would limit compliance with study
             requirements

          -  Patents must have no contraindication to cisplatin chemotherapy including no
             clinically significant hearing loss unless willing to accept the potential of further
             loss of hearing, no symptomatic peripheral neuropathy

          -  Women must not be pregnant or breast-feeding

          -  All females of childbearing potential must have a blood test or urine study within 2
             weeks prior to registration to rule out pregnancy

          -  A female of childbearing potential is any woman, regardless of sexual orientation or
             whether they have undergone tubal ligation, who meets the following criteria: 1) has
             not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
             postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in
             the preceding 24 consecutive months)

          -  Women of childbearing potential and sexually active males must be strongly advised to
             use an accepted and effective method of contraception or to abstain from sexual
             intercourse for the duration of their participation in the study

          -  Patients must not have received any study therapies prior to registration

          -  Pemetrexed/cisplatin therapy; note: patients who will receive pemetrexed/cisplatin
             therapy must meet all eligibility criteria below:

               -  Patients assigned to pemetrexed/cisplatin therapy must NOT have squamous cell
                  histology

               -  Calculated creatinine clearance must be obtained within 2 weeks of registration
                  and calculated creatinine clearance (CrCl) must be >= 45mL/min using the standard
                  Cockcroft and Gault formula, or the measured glomerular filtration rate (GFR)
                  using the appropriate radiolabeled method (51-CrEDTA or Tc99m-DTPA) must be used
                  to calculate CrCl

          -  Patients should have no contraindications for FDG-PET/CT