Phase 2b Randomized Controlled Study of Tecemotide (L-BLP25) for Immunotherapy of NSCLC (Non-Small Cell Lung Cancer)

An adverse event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition, whether or not related to study drug. A serious AE was an AE that results in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with TEAEs, serious TEAEs, TEAEs leading to death, and TEAEs with CALGB toxicity Grade 3 or 4 were reported.

Time frame: From the first dose of study drug administration until 30 days after the last dose of study drug administration or assessed until cut-off date (15 March 2006)

Population: Analysis population included all participants randomized in the study.

Time from randomization to death or last day known to be alive. Participants without event were censored at the last date known to be alive or at the clinical cut-off date (15 March 2006), whichever was earlier.

Time frame: Time from randomization to death or last day known to be alive, reported between day of first participant randomized that is, 08 August 2000, up to cut-off (15 March 2006)

Population: Analysis population included all randomized participants.

Functional Assessment of Cancer Therapy - Lung cancer (FACT-L) is a valid instrument used to measure quality of life (QoL) in participants with cancer consisting of the 27-item FACT-General (G) and 9-item lung cancer subscale (LCS). FACT-G is organized into subscales: physical well-being (PWB)-7 items; social/family well-being (SWB)-7 items; emotional well-being (EWB)-6 items; functional well-being (FWB)-7 items. Each item uses a 5 point rating scale (0=not at all and 4=equals very much). FACT-L total score=4 subscales + LCS and ranges from 0 to 144. Higher scores indicate better QOL.

Time frame: At baseline, Week 4, Week 8 and then at 12 Week intervals beginning at week 19 until withdrawal/discontinuation from the study.

Population: Analysis population included all the participants with a baseline and at least one post-baseline complete FACT-L questionnaire. n signifies number of participants evaluable at each timepoint for this outcome measure, for each reporting group, respectively.

CA 27-29 is a blood test used to monitor certain types of cancer. CA 27-29 is the name of an antigen, which is a substance that stimulates your body's defense system. CA27-29 antigen levels were determined on all participants and assessed the disease burden of participants at study entry, evaluated early recurrence, presence of residual disease, continued remission or poor prognosis.

Time frame: Study entry, Week 8

Population: Analysis population included all randomized participants. n signifies number of participants evaluable at each timepoint for this outcome measure, for each reporting group, respectively.

T-cell proliferation assays were performed and the number of participants with positive mucinous glycoprotein 1 (MUC1) specific T-cell proliferative response were reported.

Time frame: Time from randomization until cut-off date (15 March 2006)

Population: Analysis population included all randomized participants. N signifies total number of participants who were evaluable for this measure. T-cell measure was done only on arm A where subjects received tecemotide for induction of t-cell response. Therefore arm B BSC did not have any samples taken for this assessment.