Wu 2011

Trial name or title	Cancer vaccine study for stage III, unresectable, non‐small cell lung cancer (NSCLC) in the Asian population (INSPIRE)
Methods	International RCT (45 investigation sites in 5 countries ), Phase III
Participants	Number of participants: 285 (03 Dec 2009 to 10 Sep 2014) Number randomised: Experimental group (Tecemotide (L‐BLP25) + Cyclophosphamide + Best Supportive Care): 191 Control group (Saline + Placebo + BSC): 94 Number evaluated: Experimental group: 191, age (mean): 56.5 years (8.93) Control group: 94, age (mean): 59.3 years (9.08) Diagnosis: patients were locally advanced unresectable stage III NSCLC Inclusion: The eligibility criteria were as follows: ≥ 18 years of age; Histologically documented unresectable stage III NSCLC, with stage confirmed by imaging (CT, MRI, or PET, or a combination); Completion of chemoradiotherapy (concomitant or sequential) ≥ 4 weeks and ≤ 12 weeks prior to randomisation, consisting of ≥ 2 cycles of platinum‐based chemotherapy and a radiation dose of ≥ 50 Gy; Stable disease or objective response after primary chemoradiotherapy according to RECIST documented ≤ 4 weeks prior to randomisation ECOG performance status of 0 or 1; Platelet count ≥ 140 × 109/L; WBC ≥ 2.5 × 109/L; haemoglobin ≥ 90 g/L.
Interventions	Experimental group: A single IV infusion of 300 mg/m² (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L‐BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L‐BLP25) vaccinations at a dose of 918 mcg and then at 6‐week intervals, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics, and nutritional support. Control group: A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6‐week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
Outcomes	Data cut‐off date: June 2015 OS, PFS,time‐to‐symptom progression (TTSP), time‐to‐progression (TTP), adverse events
Starting date	December 2009
Contact information	Correspondence for published protocol: tony@clo.cuhk.edu.hk
Notes	Supported by Merck KGaA, Darmstadt, Germany This study was terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC