Clinical trial NCT01082549 (phase 3, status: completed)
Conditions: squamous cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: gemcitabine/carboplatin, gemcitabine/carboplatin plus iniparib
SMILES: [H][N]([H])([H])[Pt]1(OC(=O)C2(CCC2)C(=O)O1)[N]([H])([H])[H], [H][N]([H])([H])[Pt]1(OC(=O)C2(CCC2)C(=O)O1)[N]([H])([H])[H]
Eligibility criteria:

        Inclusion Criteria:

        Eligible patients must meet the following criteria to be enrolled in the study:

          1. Newly diagnosed, stage IV squamous cell lung cancer. This includes patients who
             present with disseminated metastases, and those with a malignant pleural or
             pericardial effusion (i.e., formerly stage IIIB in the 6th TNM staging system).

          2. Patients who have received prior adjuvant therapy for early-stage lung cancer are
             eligible if at least 12 months have elapsed from that treatment.

          3. Histologically confirmed squamous cell bronchogenic carcinoma. Patients whose tumors
             contain mixed non-small cell histologies are eligible, as long as squamous carcinoma
             is the predominant histology. Mixed tumors with small cell anaplastic elements are not
             eligible. Cytologic specimens obtained by brushings, washings, or needle aspiration of
             the defined lesion are acceptable.

          4. Patients with previous radiotherapy as definitive therapy for locally advanced
             non-small cell lung cancer are eligible, as long as the recurrence is outside the
             original radiation therapy port. Radiation therapy must have been completed >4 weeks
             prior to the initiation of study treatment. Patients who have received chemo/radiation
             for locally advanced NSCLC are not eligible. Patients who have received palliative
             radiation therapy for symptomatic metastases must have completed treatment >14 days
             prior the initiation of the study treatment.

          5. Presence of evaluable (measureable or non-measurable) disease.

          6. ECOG Performance Status of 0 or 1.

          7. Laboratory values as follows:

               -  Absolute neutrophil count (ANC) >1,500/microL and platelets >100,000/microL (≤72
                  hours prior to initial treatment).

               -  Hemoglobin >9 g/dL (Note: Patients may be transfused or receive erythropoietin to
                  maintain or exceed this level).

               -  Bilirubin < ULN.

               -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times
                  the upper limit of normal if no liver involvement or ≤5 times the upper limit of
                  normal with liver involvement.

               -  Creatinine <2.0 mg/dL, or creatinine clearance >40 mL/min (as calculated by the
                  Cockcroft-Gault method.

          8. Women of childbearing potential must have a negative serum pregnancy test performed
             within 7 days prior to start of treatment. Women of childbearing potential or men with
             partners of childbearing potential must use effective birth control measures during
             treatment and at least 6 months after the last dose of the study treatment. If a woman
             becomes pregnant or suspects she is pregnant while participating in this study, she
             must agree to inform her treating physician immediately. Sexually active men must
             agree to use a medically acceptable form of birth control during treatment and at
             least 6 months after the last dose. If a female partner becomes pregnant during the
             course of the study the treating physician should be informed immediately.

          9. >18 years of age.

         10. Ability to understand the nature of this study, give written informed consent, and
             comply with study requirements.

         11. Patients entering this study must be willing to provide tissue from a previous tumor
             biopsy (if available) for correlative testing. An exception to this is when the
             national/local regulations prohibits some of the key activities of this research like
             the export of samples to third countries, storage of coded samples or global gene
             expression profiling without a pre-specified list of target genes. If tissue is not
             available, a patient will still be eligible for enrollment into the study.

        Exclusion Criteria:

          1. Prior treatment with gemcitabine, carboplatin (except in the adjuvant setting), or
             Iniparib.

          2. Past or current history of neoplasm other than the entry diagnosis, with the exception
             of treated non-melanoma skin cancer or carcinoma in-situ of any primary site, or
             invasive cancers treated definitively, with treatment ending >5 years previously and
             no evidence of recurrences.

          3. A history of cardiac disease, as defined by:

               -  Malignant hypertension

               -  Unstable angina

               -  Congestive heart failure

               -  Myocardial infarction within the previous 6 months

               -  Symptomatic, unstable or uncontrolled, cardiac arrhythmias. Patients who have
                  stable, rate-controlled atrial fibrillation are eligible for study enrollment.

          4. Active brain metastases. Patients with treated brain metastases are eligible, if (1)
             radiation therapy was completed at least 2 weeks prior to study entry; (2) follow-up
             scan shows no disease progression; and (3) patient does not require steroids.

          5. Women who are pregnant or lactating.

          6. Any serious, active infection (> Grade 2) at the time of treatment.

          7. A serious underlying medical condition that would impair the ability of the patient to
             receive protocol treatment.

          8. A major surgical procedure, or significant traumatic injury ≤28 days of beginning
             treatment, or anticipation of the need for major surgery during the course of the
             study.

          9. Uncontrolled or intercurrent illness including, that in the opinion of the
             investigator may increase the risks associated with study participation or
             administration of the investigational products, or that may interfere with the
             interpretation of the results.

         10. History of any medical or psychiatric condition or laboratory abnormality that, in the
             opinion of the investigator, may increase the risks associated with the study
             participation or administration of the investigational products, or that may interfere
             with the interpretation of the results.

         11. Known or suspected allergy/hypersensitivity to any agent given in the course of this
             trial.

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.