Chemotherapy and Radiation in Treating Participants With Stage 3 Non-Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Cisplatin; Etoposide; Vinorelbine; Paclitaxel; Carboplatin; Thoracic Radiation Therapy (TRT)
Intervention description: infusion over 10 minutes; infusion over 60 minutes with adequate anti-emetic treatment and appropriate hydration per local practice guidelines; administered per local practice guidelines over a minimum of 30 minutes; administered over 6-10 minutes infusion per local practice guidelines; administered as a 3-hour infusion; administered per local practice guidelines over 30 minutes
Intervention MeSH terms: Paclitaxel; Etoposide; Vinorelbine; Carboplatin; Pemetrexed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 598.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the overall survival of participants with locally-advanced, Stage III
      Non-Small Cell Lung Cancer (NSCLC) with nonsquamous cell histology.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have Stage IIIA or IIIIB NSCLC of the non-squamous type

          -  Participants must have measureable tumor lesions according to the Response Evaluation
             Criteria in Solid Tumors (RECIST) guidelines or disease that can be evaluated on
             computerized tomography (CT) scan

          -  Participants must be physically mobile, take care of themselves and must be up and
             about and able to perform light activities, such as light housework or office work

          -  Participants must be 18 years of age or older

          -  Participants must have lost no more than 10% of their body weight in the previous 3
             months

          -  Women must be sterile, postmenopausal, or on contraception, and men must be sterile or
             on contraception

          -  Participants' test results assessing the function of their blood forming tissue,
             kidneys, liver, and lungs must be satisfactory

          -  Participants with Stage IIIB NSCLC who have supraclavicular nodal involvement may be
             entered into this study. However, participants with cervical nodes are not permitted.
             The upper border of supraclavicular nodes must not extend above the upper border of
             the lateral end of the clavicle, extended medially.

        Exclusion Criteria:

          -  Participants cannot have other on-going (uncontrolled) illnesses, including active
             infections, recent heart problems, or psychiatric illnesses

          -  Participants who are unable to take vitamins (including injections of vitamin B12) or
             oral cortisone medication

          -  Participants who have had a heart attack (myocardial infarction) or other cardiac
             issues within 6 months of the trial

          -  Participants who have received other investigational drugs within the last 30 days

          -  Participants who are unable to stop taking more than 1.3 grams of aspirin on a daily
             basis or non-steroidal anti-inflammatory agents

          -  Participants who have diseases considered for surgical treatment as part of their care
             plan, such as Pancoast or superior sulcus tumors

          -  Participants who had prior thoracic radiation. However, other prior radiotherapy is
             allowed. Participants must have recovered from the toxic effects of the treatment
             prior to study enrollment. Participants may not have received whole pelvis radiation
             or radiation to more than 25% of their bone marrow. Prior radiotherapy must have been
             completed at least 30 days prior to study treatment.

          -  Participants who have a radiation treatment plan that would expose more than 35% of
             the volume of their lung to 20 gray (Gy) or more of radiation

          -  Participants who have concurrent cancer from another primary site requiring treatment
             of any kind within the past 5 years. Exemptions to this will be permitted on a
             case-by-case basis after prior approval by the Sponsor physician or designate if the
             investigator believes the participant's risk of recurrence and death is very low.
             Curatively treated nonmelanoma skin cancer or in situ carcinoma of any origin is
             allowed. Participants with recurrence of a previously resected lung cancer or who have
             a second primary lung cancer are ineligible.