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EGFR inhibitors in lung cancer (metastatic) for all type of patients, 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
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
dacomitinib versus gefitinib
ARCHER 1050,
NCT01774721
dacomitinib
versus
gefitinib
Patients (pts) with newly diagnosed stage IIIB/IV/ recurrent NSCLC harboring an EGFR- activating mutation (exon 19 del or exon 21 L858R mu +/- exon 20 T790M mu)
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
osimertinib versus placebo
FLAURA, 2017
NCT02296125
osimertinib (AZD9291) (80 mg or 40 mg orally, once daily)
versus
first-line standard-of-care treatment erlotinib or gefitinib
previously untreated patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation–positive non–small cell lung cancerdouble-blind
osimertinib versus platinum-based therapy plus pemetrexed
AURA 3, 2017
NCT02151981
oral osimertinib (at a dose of 80 mg once daily)
versus
intravenous pemetrexed (500 mg per square meter of body-surface area) plus either carboplatin (target area under the curve, 5 [AUC5]) or cisplatin (75 mg per square meter) every 3 weeks for up to six cycles
patients with EGFR T790M mutation-positive, locally-advanced or metastatic NSCLC, whose disease had progressed after 1st-line EGFR tyrosine kinase inhibitor (TKI) therapy.

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