lung cancer clinical trials results

afatinib versus cisplatin-based chemotherapy
LUX-LUNG 3, 2015

versus
EGFR mutation-positive lung adenocarcinoma
LUX-LUNG 6, 2015

versus
EGFR mutation-positive lung adenocarcinoma
atezolizumab versus docetaxel
POPLAR Phase 2 atezolizumab, 2016
NCT01903993
Atezolizumab
versus
docetaxel 75 mg/m(2) once every 3 weeks
patients with locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Thopen label
13 countries in Europe and North America
OAK, 2016
NCT02008227
atelozumab
versus
docetaxel
Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy open label
Follow-up duration: minimum 19 months
bortezomib and pemetrexed versus pemetrexed
Scagliotti, 2010
Pemetrexed plus Bortezomib
versus
pemetrexed
ceritinib versus chemotherapy
ASCEND-4, 2017
NCT01828099
oral ceritinib 750 mg/day
versus
platinum-based chemotherapy ([cisplatin 75 mg/m2 or carboplatin AUC 5-6 plus pemetrexed 500 mg/m2] every 3 weeks for four cycles followed by maintenance pemetrexed
untreated patients with stage IIIB/IV ALK-rearranged non-squamous NSCLC
cetuximab versus CT
Lynch, 2010
cetuximab (400 mg/m(2) on day 1, 250 mg/m(2) weekly) was administered until progression or unacceptable toxicity plus taxane/carboplatin
versus
paclitaxel (225 mg/m(2)) or docetaxel (75 mg/m(2)), at the investigator's discretion, and carboplatin (area under the curve = 6) on day 1 every 3 weeks for < or = six cycles
chemotherapy-naïve patients with stage IIIB (pleural effusion) or IV NSCLC, without restrictions by histology or epidermal growth factor receptor expressionopen-label
cetuximab versus CT alone
Butts, 2007
cetuximab (400 mg/m2 i.v
versus
cisplatin (75 mg/m2 i.v., every 3 weeks) or carboplatin (area under the concentration-versus-time curve of 5 intravenously [i.v.], every 3 weeks), and gemcitabine (1,250 or 1,000 mg/m2 i.v., days 1 and 8)
chemotherapy-naïve patients with recurrent/metastatic NSCLC (stage IV or stage IIIB with malignant pleural effusion)
cetuximab + CT versus CT alone
FLEX (Pirker), 2009
NCT00148798
Cetuximab-at a starting dose of 400 mg/m(2) intravenous infusion over 2 h on day 1, and from day 8 onwards at 250 mg/m(2) over 1 h per week-was continued after the end of chemotherapy until disease progression or unacceptable toxicity + CT
versus
cisplatin 80 mg/m(2) intravenous infusion on day 1, and vinorelbine 25 mg/m(2) intravenous infusion on days 1 and 8 of every 3-week cycle) for up to six cycles
chemotherapy-naive patients with advanced EGFR-expressing histologically or cytologically proven stage wet IIIB or stage IV non-small-cell lung cancer open-label
Rosell, 2008
cetuximab treatment (initial dose 400 mg/m(2), followed by 250 mg/m(2) weekly thereafter) + same CT
versus
for a maximum of eight cycles, patients received three-weekly cycles of cisplatin (80 mg/m(2), day 1) and vinorelbine (25 mg/m(2) on days 1 and 8) alone
first-line therapy in EGFR-expressing advanced non-small-cell lung cancer
crizotinib versus chemotherapy
Shaw, 2013
NCT00932893
crizotinib (250 mg) twice daily
versus
intravenous chemotherapy with either pemetrexed (500 mg per square meter of body-surface area) or docetaxel (75 mg per square meter) every 3 weeks
patients with locally advanced or metastatic ALK-positive lung cancer who had received one prior platinum-based regimenopen-label
PROFILE 1014, 2014
NCT01154140
oral crizotinib, at a dose of 250 mg twice daily
versus
Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin
Patients With ALK Positive Non Squamous Cancer Of The Lung
Follow-up duration: 16.7 months
enzastaurin plus pemetrexed versus pemetrexed
Chiappori, 2010
Pemetrexed plus enzastaurin
versus
pemetrexed
erlotinib versus Platinum-based CT
OPTIMAL ,
NCT00874419
oral erlotinib (150 mg/day) until disease progression or unacceptable toxic effects
versus
up to four cycles of gemcitabine plus carboplatin
Patients older than 18 years with histologically confirmed stage IIIB or IV NSCLC and a confirmed activating mutation of EGFR (exon 19 deletion or exon 21 L858R point mutation) open-label
EUTRAC,
NCT00446225
oral erlotinib 150 mg per day
versus
3 week cycles of standard intravenous chemotherapy of cisplatin 75 mg/m(2) on day 1 plus docetaxel (75 mg/m(2) on day 1) or gemcitabine (1250 mg/m(2) on days 1 and 8).
adults (> 18 years) with NSCLC and EGFR mutations (exon 19 deletion or L858R mutation in exon 21) with no history of chemotherapy for metastatic disease (neoadjuvant or adjuvant chemotherapy ending ¡Ý 6 months before study entry was allowed)open-label
TITAN,
NCT00556322
erlotinib 150 mg/day
versus
chemotherapy (standard docetaxel or pemetrexed regimens, at the treating investigators' discretion) until unacceptable toxicity, disease progression, or death
second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis open-label
erlotinib + Platinum-based CT versus Platinum-based CT
TRIBUTE (Herbst),
erlotinib 150 mg/d combined with up to six cycles of carboplatin and paclitaxel, followed by maintenance monotherapy with erlotinib
versus
placebo combined with up to six cycles of carboplatin and paclitaxel, followed by maintenance monotherapy with erlotinib
patients with good performance status and previously untreated advanced (stage IIIB/IV) NSCLC
Gatzemeier ,
Erl 150 mg/day plus (Gem 1,250 mg/m2 D1,8 and Cis 80 mg/m2 D1)*6 cycles
versus
Gem 1,250 mg/m2 D1,8 and Cis 80 mg/m2 D1)*6 cycles
first-line treatment for advanced non-small-cell lung cancer
Mok ,
Erl 150 mg/day plus (Gem 1,250 mg/m2 D1,8 and either Cis75 mg/m2 D1 or Car AUC = 5, D1)
versus
Gem 1,250 mg/m2 D1,8 and either
first-line treatment for advanced non-small-cell lung cancer
SATURN (Cappuzzo),
NCT00556712
Erl 150 mg/day plus select one of seven standard chemotherapy regimens
versus
Cis75 mg/m2 D1 or Car AUC = 5, D1
maintenance treatment in advanced non-small-cell lung cancer
Boutsikou,
Erl 150 mg/day plus (Doc 100 mg/ m 2 and Car AUC = 5.5 q28d*4)
versus
Doc 100 mg/m2 and Car AUC = 5.5 q28d*4
first-line treatment of patients with NSCLC
Lee ,
NCT00550173
Erl 150 mg/day plus Pem 500 mg/ m 2 D1 q21d
versus
Pem 500 mg/m2 D1 q21d
second-line treatment for never-smokers with non-squamous non-small cell lung cancer
Stinchcombe,
Erl 150 mg/day plus Gem 1,200 mg/m2 D1,8 q21d
versus
Gem 1,200 mg/m2 D1,8 q21d
elderly patients (age ¡Ý70 years) with stage IIIB or IV non-small cell lung cancer
FASTACT-2 (Wu) ,
NCT00883779
Erl 150 mg/day plus Gem 1,250 mg/m2 D1,8, six cycles and Car AUC = 5 or Cis 75 mg/ m 2,D1
versus
Gem 1,250 mg/m2, d1,8, six cycles and Car AUC = 5 or Cis 75 mg/ m 2,D1
patients with untreated stage IIIB/IV non-small-cell lung cancer
gefitinib versus carboplatin-paclitaxel
NEJ002, 2013

versus
chemo-naïve non-small cell lung cancer with sensitive EGFR gene mutations
Maemondo, 2010
UMIN-CTR C000000376

versus
patients with metastatic, non-small-cell lung cancer and EGFR mutations who had not previously received chemotherapy
IPASS (Mok), 2009
NCT00322452

versus
previously untreated patients in East Asia who had advanced pulmonary adenocarcinoma and who were nonsmokers or former light smokers
gefitinib versus carboplatin/paclitaxel
IPASS,

versus
previously untreated never-smokers and light ex-smokers with advanced pulmonary adenocarcinoma
gefitinib versus cisplatin plus docetaxel
WJTOG3405 (Mitsudomi), 2010

versus
patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor
gefitinib versus continued platinum-doublet chemotherapy
WJTOG0203 (Takeda), 2010

versus
Japanese patients with advanced non-small-cell lung cancer
gefitinib versus docetaxel
ISTANA (Lee), 2010

versus
previously treated advanced nonsmall-cell lung cancer
V-15-32 (Maruyama), 2008

versus
previously treated advanced nonsmall-cell lung cancer
INTEREST (Kim), 2008

versus
previously treated advanced nonsmall-cell lung cancer
SIGN (Cufer), 2006

versus
previously treated advanced nonsmall-cell lung cancer
IFCT-0301 study (Morère), 2010

versus
patients with advanced non-small-cell lung cancer and a performance status of 2 or 3
gefitinib versus gefitinib
Kris, 2003

versus
Patients either stage IIIB or IV NSCLC for which they had received at least 2 chemotherapy regimensdouble blind
gefitinib versus gemcitabine and cisplatin
First Signal,
gefitinib (250 mg daily)
versus
GP chemotherapy (gemcitabine 1,250 mg/m(2) on days 1 and 8; cisplatin 80 mg/m(2) on day 1 every 3 weeks, for up to nine courses
first-line therapy of never-smokers with adenocarcinoma of the lung
gefitinib versus placebo
NCIC CTG BR19 (Goss), 2013
gefitinib 250 mg per day
versus
placebo
completely resected non-small-cell lung cancerdouble-blind
INFORM; C-TONG 0804, 2012
NCT00770588

versus
maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer
EORTC 08021/ILCP 01/03, 2011
NCT00091156

versus
patients with advanced NSCLC, non-progressing after first line platinum-based chemotherapy
Goss, 2009

versus
chemotherapy-naive patients with advanced non-small-cell lung cancer and poor performance status
SWOG S0023 (Kelly), 2008

versus
inoperable stage III non-small-cell lung cancer
ISEL, 2006

versus
patients of Asian origin with refractory advanced non-small cell lung cancer
Tsuboi, 2005

versus
patients with completely resected non-small cell lung cancer
gefitinib versus vinorelbine
INVITE (Crinò), 2008
NCT00256711

versus
chemotherapy-naive elderly patients with advanced non-small-cell lung cancer
gefitinib paclitaxel and carboplatin versus paclitaxel and carboplatin
INTACT 2, 2004
gefitinib plus paclitaxel and carboplatin
versus
paclitaxel 225 mg/m(2) and carboplatin area under concentration/time curve of 6 mg/min/mL (day 1 every 3 weeks)
chemotherapy-naive patients with advanced NSCLCdouble-blind
gefitinib + gemcitabine/cisplatin versus placebo + gemcitabine / cisplatin
INTACT 1.,
gefitinib 500 mg/d, gefitinib 250 mg/d,
versus
placebo
chemotherapy-naive patients with unresectable stage III or IV NSCLCdouble blind
matuzumab plus pemetrexed versus pemetrexed
Schiller, 2010
Pemetrexed plus matuzumab
versus
pemetrexed
nivolumab versus docetaxel
CheckMate 057, 2015
NCT01673867
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression
versus
Docetaxel 75 mg/m² concentrate for solution for intravenous infusion every 3 weeks until documented disease progression
patients with advanced nonsquamous nonsmall cell lung cancer (NSCLC) who had progressed on platinum-doublet chemotherapy open
CheckMate 017, 2015
NCT01642004
Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression
versus
Docetaxel 75 mg/m2 solution intravenously every 3 weeks until documented disease progression
patients with advanced SQ NSCLC who fail platinum-based doublet chemotherapy open
nivolumab versus Standard of Care
CheckMate 026, 2016
NCT02041533
Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression
versus
Investigator's Choice Chemotherapy administered in 3-week cycles up to a maximum of 6 cycles of Intravenous injection until disease progression
patients with previously untreated advanced non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 at >5% (>1%???). Patients with EGFR activating mutations and ALK translocations, which are sensitive to targeted therapy, were excluded. open design
paclitaxel 80mg/m2 versus m2docetaxel 36 mg/
Esteban, 2003
paclitaxel 80 mg/m2 as a 1 h weekly infusion for 6 weeks followed by a 2-week rest
versus
docetaxel 36 mg/m2 as a 1 h weekly infusion for 6 weeks followed by a 2-week rest.
patients with NSCLC previously treated with platinum-based chemotherapy
pembrolizumab versus Standard of Care
Keynote 024, 2015
NCT02142738
Pembrolizumab (200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD
versus
standard of care (SOC) platinum-based chemotherapies
previously untreated advanced NSCLC with PD-L1 expression on at least 50% of tumor cells and no sensitizing mutation of the epidermal growth factor receptor gene or translocation of the anaplastic lymphoma kinase gene open label
Follow-up duration: 11.2 months (median)
pembrolizumab 10mg versus docetaxel
Keynote 010 10mg, 2015
NCT01905657
pembrolizumab 10 mg/kg
versus
docetaxel 75 mg/m² every 3 weeks
patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer open-label
pembrolizumab 2mg versus docetaxel
Keynote 010 2mg, 2015
NCT01905657
pembrolizumab 2 mg/kg
versus
docetaxel 75 mg/m² every 3 weeks
patients with previously treated, PD-L1-positive, advanced non-small-cell lung canceropen-label
pemetrexed versus bortezomib
Scagliotti (pemetrexed vs bortezomib), 2010
pemetrexed
versus
bortezomib
pemetrexed versus docetaxel
Chen, 2008

versus
Hanna, 2004
pemetrexed 500 mg/m(2) intravenously (i.v.) day 1 with vitamin B(12), folic acid, and dexamethasone
versus
docetaxel 75 mg/m(2) i.v. day 1 with dexamethasone every 21 days
patients with advanced non-small-cell lung cancer (NSCLC) previously treated with chemotherapy
Li, 2012
pemetrexed 500 mg/m(2) intravenously day 1 with vitamin B12, folic acid, and dexamethasone
versus
docetaxel 75 mg/m(2) intravenously day 1 with dexamethasone
patients with histological or cytological diagnosis of stage IIIB or IV NSCLC, who were not suitable for curative therapy and had failed from prior first line chemotherapy regimen for at least 4 weeks
Sun, 2013
NCT00391274
pemetrexed (500 mg/m(2); on Day 1 of each 21-day cycle
versus
docetaxel (75 mg/m(2) on Day 1 of each 21-day cycle
second-line therapy for Chinese patients with locally advanced or metastatic non-small cell lung cancer open-label
pemetrexed plus carboplatin versus docetaxel plus carboplatin
Jose, 2011
carboplatin (area under the curve = 5 mg/ml × min) and pemetrexed (500 mg/m(2)) 21-day cycle (maximum of six cycles).
versus
docetaxel (75 mg/m(2)).
first-line treatment for advanced, nonsquamous non-small cell lung cancer
Socinski, 2010
pemetrexed 500 mg/m and carboplatin area under the curve 6 once every 3 weeks for up to 6 cycles
versus
docetaxel 75 mg/m and carboplatin area under the curve 6 once every 3 weeks for up to six cycles
Patients with stage IIIB (with pleural effusion) or IV non-small cell lung cancer and performance status 0 or 1
pemetrexed plus carboplatin versus pemetrexed
Smit, 2009
Pemetrexed plus carboplatin
versus
pemetrexed
vandetanib plus pemetrexed versus pemetrexed
De Boer, 2011
Vandetanib plus pemetrexed
versus
pemetrexed
weekly docetaxel versus 3-weekly docetaxel
DISTAl 01 (Gridelli) , 2004

versus
patients with advanced NSCLC patients, < or =75 years, ECOG PS < or =2
Camps ,
docetaxel 36 mg/m(2) given weekly (1W arm) for 6 weeks followed by 2 weeks of rest
versus
docetaxel 75 mg/m(2) administered every 3 weeks
Schuette ,

versus
Gervais ,

versus
Lai ,

versus
Chen ,

versus