Table 1:

Ongoing clinical trials of immunotherapies for non-small-cell lung cancer

	Intervention	Study design	Estimated enrolment (n)	Stage	Main eligibility requirements	Endpoints
START	Liposomal BLP25 or placebo	Phase 3 randomised, double-blind placebo-controlled	1476	Unresectable stage III	Stable disease or objective response after primary chemoradiotherapy. Two or more cycles of platinum-based chemotherapy, ≥50 Gy radiation chemotherapy, ≥50 Gy radiation	Primary: OS. Secondary: time to symptom progression, time to disease progression, 1, 2, and 3 year survival, safety
INSPIRE	Liposomal BLP25 or placebo	Phase 3 randomised, double-blind placebo-controlled	420	Unresectable stage III	Stable disease or objective response after primary chemoradiotherapy. Two or more cycles of platinum-based chemotherapy, ≥50 Gy radiation	Primary: OS. Secondary: time to symptom progression, time to disease progression, PFS, time to treatment failure, safety
STOP	Belagenpumatucel-L or placebo	Phase 3 randomised, double-blind placebo-controlled	506	Unresectable stage III or IV	Stable disease or objective response after primary platinum-based chemoradiotherapy	Primary: OS. Secondary: PFS, quality of life, time to progression, objective response, response duration, rate of CNS metastases development, safety
MAGRIT	MAGE-A3 vaccine or placebo	Phase 3 randomised, double-blind placebo-controlled	2270	Completely resected, stage IB, II, or IIIA	Tumour expresses MAGE-A3 gene.	Primary: disease-free survival. Secondary: lung-cancer-specific survival, OS, anti-MAGE-A3 and anti-protein D seropositivityrate, adverse events
Randomised trial of ipilimumab in squamous cell lung cancer	Ipilimumab, carboplatin, paclitaxel or placebo, carboplatin, and paclitaxel	Phase 3 randomised,double-blind placebo-controlled	920	Stage IV or recurrent	Squamous cell histology	Primary: OS. Secondary: PFS, objective response
FORTIS-M	Talactoferrin or placebo	Phase 3 randomised, double-blind placebo-controlled	720	Stage IIIB or IV	Progressive disease after two or more previous systemic therapies	Primary: OS. Secondary: PFS, objective response, disease stabilisation rate, safety
FORTIS-C	Talactoferrin, carboplatin, paclitaxel or placebo, carboplatin, paclitaxel	Phase 3 randomised, double-blind placebo-controlled	1100	Stage IIIB or IV	No previous systemic anti-cancer therapy for non-small-cell lung cancer	Primary: OS, PFS. Secondary: objective rate, disease stabilisation rate, safety

MAGE=melanoma-associated antigen. PFS=progression-free survival. OS=overall survival.