Safety and Efficacy Study of Abraxane in Combination With Carboplatin to Treat Advanced NSCL Cancer in the Elderly
Condition: Non-Small Cell Lung Cancer; Carcinoma; Squamous Cell Carcinoma; Adenocarcinoma; Carcinoma, Large Cell; Lung Neoplasm
MeSH terms: Carcinoma; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma; Carcinoma, Large Cell
Intervention: nab-paclitaxel; Carboplatin
Intervention MeSH terms: Paclitaxel; Carboplatin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 143.0
Sex: All
Minimum age: 70 Years
Healthy volunteers: No
Keywords: NSCLC advanced non-small cell lung cancer squamous adenocarcinoma large cell carcinoma lung cancer elderly first line treatment abraxane carbo nab-paclitaxel

Summary:

      Study comparing two regimens of nab-paclitaxel and carboplatin combination in elderly
      subjects (≥ 70 years old) with advanced NSCLC
    

Eligibility criteria:

        Inclusion Criteria: -

          -  Inclusion Criteria: -

               1. Age ≥ 70 years at the time of signing the Informed Consent Form.

               2. Understand and voluntarily provide written informed consent prior to the conduct
                  of any study related assessments/procedures.

               3. Able to adhere to the study visit schedule and other protocol requirements.

               4. Histologically or cytologically confirmed locally advanced or metastatic non
                  small cell lung cancer who are not candidates for curative surgery or radiation
                  therapy.

               5. No other current active malignancy requiring anticancer therapy.

               6. Radiographically documented measurable disease per RECIST v 1.1

               7. No prior chemotherapy for the treatment of metastatic disease. Adjuvant
                  chemotherapy is permitted providing that cytotoxic chemotherapy was completed 12
                  months prior to signing the informed consent form (ICF) and without disease
                  recurrence. Participans with previously known epidermal growth factor receptor
                  mutation or anaplastic lymphoma kinase gene translocation must have failed or had
                  intolerance to one treatment with epidermal growth factor receptor tyrosine
                  kinase inhibitor or anaplastic lymphoma kinase inhibitor therapy, respectively.

               8. Absolute neutrophil count ≥ 1500 cells/cubic millimetre.

               9. Platelets ≥ 100,000 cells/cubic millimetre.

              10. Hemoglobin ≥ 9 grams/decilitre.

              11. Aspartate transaminase/serum glutamic oxaloacetic transaminase/ alanine
                  transaminase/serum glutamic pyruvic transaminase ≤ 2.5 × upper limit of normal
                  range or ≤ 5.0 × upper limit of normal range if liver metastases.

              12. Total bilirubin ≤ 1.5 millilitre/decilitre (unless there is a known history of
                  Gilberts Syndrome).

              13. Creatinine clearance > 40 millilitre/minute calculated using Cockcroft-Gault
                  equation (if renal impairment is suspected 24 hour urine collection for
                  measurement is required).

              14. Eastern Cooperative Oncology Group performance status 0 or 1.

              15. Females who (1) have undergone hysterectomy (the surgical removal of the uterus)
                  or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have been
                  naturally postmenopausal for at least 24 consecutive months (ie, has not had
                  menses at any time during the preceding 24 consecutive months).

              16. Male subjects must: Practice true abstinence or agree to use a condom during
                  sexual contact with a pregnant female or a female of childbearing potential while
                  participating in the study, during dose interruptions and for 6 months following
                  study drug discontinuation, even if he has undergone a successful vasectomy.

                  Exclusion Criteria:

          -  1. Evidence of active brain metastases, including leptomeningeal involvement (prior
             evidence of brain metastasis are permitted only if treated and stable and off therapy
             for ≥ 4 weeks prior to signing Informed consent form. Magnetic Resonance Imaging of
             the brain (or Computed Tomography scan w/contrast) is preferred for diagnosis.

             2. History of leptomeningeal disease. 3. Only evidence of disease is non measurable.
             4. Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology
             Criteria for Adverse Events v4.0).

             5. Participant has received radiotherapy ≤ 4 weeks or limited field radiation for
             palliation ≤ 2 weeks prior to starting investigational product, and/or from whom ≥ 30%
             of the bone marrow was irradiated. Prior radiation therapy to a target lesion is
             permitted only if there has been clear progression of the lesion since radiation was
             completed.

             6. Venous thromboembolism within 1 month prior to signing informed consent form.

             7. Current congestive heart failure (New York Heart Association Class II-IV). 8.
             History of the following within 6 months prior to first administration of a study
             drug: a myocardial infarction, severe/unstable angina pectoris,coronary/peripheral
             artery bypass graft, New York Heart Association Class III-IV heart failure,
             uncontrolled hypertension, clinically significant cardiac dysrhythmia or clinically
             significant Electrocardiogram abnormality, cerebrovascular accident, transient
             ischemic attack, or seizure disorder.

             9. Participant has a known infection with hepatitis B or C, or history of human
             immunodeficiency virus infection, or participant is receiving immunosuppressive or
             myelosuppressive medications that would in the opinion of the investigator, increase
             the risk of serious neutropenic complications.

             10. Participant has an active, uncontrolled bacterial, viral, or fungal infection(s)
             requiring systemic therapy, defined as ongoing signs/symptoms related to the infection
             without improvement despite appropriate antibiotics, antiviral therapy, and/or other
             treatment.

             11.History of interstitial lung disease, sarcoidosis, silicosis, idiopathic pulmonary
             fibrosis, or pulmonary hypersensitivity pneumonitis.

             12. Treatment with any investigational product within 28 days prior to signing the
             informed consent form.

             13. History of allergy or hypersensitivity to nab-paclitaxel or carboplatin. 14.
             Currently enrolled in any other clinical protocol or investigational trial that
             involves administration of experimental therapy and/or therapeutic devices. 15. Any
             other clinically significant medical condition, psychiatric illness, and/or organ
             dysfunction that will interfere with the administration of the therapy according to
             this protocol or which, in the views of investigator, preclude combination
             chemotherapy.

             16. Participant has any other malignancy within 5 years prior to randomization.
             Exceptions include the following: squamous cell carcinoma of the skin, in-situ
             carcinoma of the cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the
             breast, or incidental histological finding of prostate cancer Tumor, Lymph Node,
             Metastatic (TNM stage of T1a or T1b). All treatment of which should have been
             completed 6 months prior to signing Informed consent form.

             17. Any condition including the presence of laboratory abnormalities, which places the
             participant at unacceptable risk if he/she were to participate in the study.

             18. Any medical condition that confounds the ability to interpret data from the study.

             19. Females who (1) have not undergone hysterectomy (the surgical removal of the
             uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or (2) have
             not been naturally postmenopausal for at least 24 consecutive months (ie, has had
             menses at any time during the preceding 24 consecutive months).