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immune checkpoint inhibition in lung cancer (metastatic) for all type of patients, clinical trials results

atezolizumab versus docetaxel
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
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
atezolizumab + bevacizumab versus bevacizumab (on top platinum-based CT)
IMpower150 (Teff), 2018
NCT02366143
atezo + bev + C + P
versus
bev + C + P
chemotherapy-naïve patients with Stage IV non-squamous non-small cell lung cancer and expression of a tumour T-effector gene signature (Teff) and EGFR et ALK negative (wild type)open label
IMpower150 (WT), 2018
NCT02366143
atezo + bev + C + P;
versus
bev + C + P
wild type chemotherapy-naïve patients with Stage IV non-squamous non-small cell lung cancer (EGFR et ALK negative)open label
durvalumab versus placebo
PACIFIC, 2017
NCT02125461
Durvalumab (at a dose of 10 mg per kilogram of body weight intravenously) every 2 weeks for up to 12 months, administered 1 to 42 days after the patients had received chemoradiotherapy
versus
placebo
patients with stage III NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapydouble-blind
durvalumab + tremelimumab versus Standard of Care
ARCTIC PD-L1 negative, 2018
NCT02352948
combination of MEDI4736 (durvalumab) plus tremelimumab
versus
Standard of Care
patients with PD-L1 negative Locally Advanced or Metastatic Non Small Cell Lung Cancer who have received at least 2 prior systemic treatment regimens including 1 platinum-based chemotherapy regimen for NSCLC
ipilimumab + chemotherapy versus placebo + chemotherapy
Reck, 2016
NCT01450761
ipilimumab 10 mg/kg plus etoposide and platinum (cisplatin or carboplatin)
versus
placebo plus etoposide and platinum (cisplatin or carboplatin)
patients with newly diagnosed extensive-stage disease SCLCdouble-blind
Govindan, 2017
NCT01285609
ipilimumab 10 mg/kg + paclitaxel and carboplatin
versus
placebo + paclitaxel and carboplatin
Patients with stage IV or recurrent chemotherapy-naïve squamous NSCLCdouble-blind
phase 2 (phased ipilimumab), 2012
concurrent ipilimumab (four doses of ipilimumab plus paclitaxel and carboplatin followed by two doses of placebo plus paclitaxel and carboplatin) or phased ipilimumab (two doses of placebo plus paclitaxel and carboplatin followed by four doses of ipilimum
versus
paclitaxel (175 mg/m(2)) and carboplatin (area under the curve, 6)
Patients with chemotherapy-naive non-small-cell lung cancer double-blind
nivolumab versus docetaxel
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 chemotherapyopen
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 chemotherapyopen
nivolumab versus platinum-based CT
CheckMate 026, 2016
NCT02041533
Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression
versus
platinum-based chemotherapy (administered once every 3 weeks for up to six cycles).
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
nivolumab + CT versus platinum-based CT
CheckMate 227 (nivolumab + CT), 2018
NCT02477826
Nivolumab + chemotherapy
versus
chemotherapy
Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer <1% tumor PD-L1 expression No masking
nivolumab + ipilimumab versus platinum-based CT
CheckMate 227 (High Tumor Mutational Burden), 2018
NCT02477826
nivolumab plus ipilimumab
versus
chemotherapy
patients with stage IV or recurrent NSCLC that was not previously treated with chemotherapy and high tumor mutational burden (>=10 mutations per megabase), irrespective of PD-L1 expression levelNo masking
pembrolizumab versus platinum-based CT
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 geneopen label
Follow-up duration: 11.2 months (median)
Keynote 042 (>=1%), 2018
NCT02220894
pembrolizumab 200 mg every 3 wk for 35 cycles or until disease progression, intolerable toxicity
versus
investigator's choice of carboplatin plus paclitaxel or carboplatin plus pemetrexed for a maximum of 6 cycles
Treatment Naïve Subjects With PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer open label
Follow-up duration: 12.8-mo median
28 countries in Asia, Canada, Europe, and South America
Keynote 042 (>=20%), 2018
NCT02220894
pembrolizumab
versus
SOC Treatment (Platinum-based Chemotherapy)
Treatment Naïve Subjects With PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer open label
Follow-up duration: 12.8-mo median
china
Keynote 042 (>=50%), 2018
NCT02220894
pembrolizumab
versus
SOC Treatment (Platinum-based Chemotherapy)
Treatment Naïve Subjects With PD-L1 Positive Advanced or Metastatic Non-Small Cell Lung Cancer open label
Follow-up duration: 12.8-mo median
china
pembrolizumab + platinum-based CT versus platinum-based CT
Keynote 189, 2018
NCT02578680
pemetrexed and a platinum-based drug plus 200 mg of pembrolizumab, followed by pembrolizumab for up to a total of 35 cycles plus pemetrexed maintenance therapy
versus
pemetrexed and a platinum-based drug plus placebo every 3 weeks for 4 cycles, followed by placebo
participants with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease and without sensitizing EGFR or ALK mutationsdouble-blind
Follow-up duration: 10.5 mo median
KEYNOTE-021 phase 2, 2016
NCT02039674
24 months treatment with pembrolizumab (200mg every three weeks)+ CT
versus
four cycles of carboplatin and pemetrexed (500 mg/m2 every three weeks)
patients with stage IIIB/IV, chemotherapy-naive, nonsquamous non-small-cell lung canceropen design
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 non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cellsopen-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 non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cellsopen-label
pembrolizumanb + CT versus platinum-based CT
Keynote 407, 2018
NCT02775435
pembrolizumab + carboplatin and paclitaxel or nano particle albumin-bound paclitaxel (nab-paclitaxel)
versus
carboplatin and paclitaxel or nano particle albumin-bound paclitaxel (nab-paclitaxel)
adults with first line metastatic squamous non-small cell lung cancer open-label
Follow-up duration: 7?7 mo (median)

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