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atezolizumab alone (n=613) vs. docetaxel (n=612)
randomized controlled trial
atelozumab
Atezolizumab intravenous 1200 mg fixed dose every 3 weeks
docetaxel
docetaxel at 75 mg/m² every 3 weeks
No crossover to atezolizumab was allowed
mNSCLC - L2 - all population
Patients with EGFR mutations or an ALK fusion oncogene were additionally required to have received previous tyrosine kinase inhibitor therapy. Results from ITT 1225
open label
194 academic or community oncology centres in 31 countries
P3/ two sided no interim analysis planned. A splitting between the ITT population [a=3%] and the PDL1 TC1/2/3 or IC1/2/3 population [a=2%]) and reallocation 5% to OS SG TC2/3 and then TC3 was planned. An initial analysis with 850 patients was planned, but an amendement modified the population to 1225 before the analysis. Here we report the final results in ITT1225
Atezolizumab treatment significantly improve overall survival versus docetaxel in previously treated non-small-cell lung cancer, regardless of PD-L1 expression or histology
atezolizumab alone (n=144) vs. docetaxel (n=143)
randomized controlled trial
atezolizumab
atezolizumab 1200 mg once every 3 weeks
docetaxel
docetaxel 75 mg/m(2) once every 3 weeks
No docetaxel-to-atezolizumab crossover was allowed.
mNSCLC - L2 - all population
no specific information about EGFR or ALK status at inclusion
open label
61 academic medical centres and community oncology practices across 13 countries in Europe and North
P2/ two sided and three interim analysis. Hierarchical testing procedure with OS in PDL1 subgroups
Atezolizumab significantly improved survival compared with docetaxel in patients with previously treated NSCLC.
avelumab alone (n=396) vs. docetaxel (n=396)
randomized controlled trial
avelumab
10 mg/kg avelumab intravenously over 1 h once every 2 weeks, Dose modification of avelumab was not permitted.
docetaxel
75 mg/m docetaxel intravenously over 1 h every 3 weeks
No crossover to avelumab was permitted.
mNSCLC - L2 - all population
Patients were not eligible if they had non-squamous cell NSCLC harbouring an EGFR or ALK mutation
open label
173 hospitals and cancer treatment centres in 31 countries
P3/ one sided and one interim analysis. Hierarchical testing procedure with secondary endpoints
Compared with docetaxel, avelumab did not improve overall survival in patients with platinum-treated PD-L1-positive NSCLC nor in ITT population, but had a favourable safety profile
nivolumab alone (n=338) vs. docetaxel (n=166)
randomized controlled trial
nivolumab
nivolumab 3 mg/kg every 2 weeks
docetaxel
docetaxel 75 mg/m2 every 3 weeks
mNSCLC - L2 - all population
patients with EGFR-mutation–positive tumors or knownALK receptor tyrosine kinase (ALK) translocation–positive tumors were excluded.
open label
32 hospitals and cancer/medical centers in China, Russia, and Singapore
P3/ two sided and one interim analysis. Hierarchical testing procedure with secondary endpoints
In this predominantly Chinese population with previously treated advanced NSCLC, nivolumab improved OS (ORR and PFS as secondary endpoints) versus docetaxel.
Tislelizumab (n=-9) vs. docetaxel (n=-9)
randomized controlled trial
Tislelizumab
100 mg per vial, 200mg intravenous (IV), Q3W
Docetaxel
75 mg/m2 IV Q3W
mNSCLC - L2 - all population
open label
P3
durvalumab plus osimertinib (n=14) vs. osimertinib (n=15)
randomized controlled trial
durvalumab plus osimertinib
durvalumab (10 mg/kg administered intravenously every 2 weeks) plus osimertinib (80 mg once daily)
osimertinib
osimertinib (80 mg once daily)
mNSCLC - L2 - EGFR mutant
Disease progression after EGFR-TKI therapy was mandatory; other lines of therapy also may have been given.
open design
nine centers in South Korea, Canada, and the Republic of China
P3/ no alpha no interim analysis. All results are exploratory. CAURAL recruitment was terminated early because of increased incidence of interstitial lung disease–like events in the osimertinib plus durvalumab arm from the separate phase Ib TATTON trial (NCT02143466).
efficacy related objectives are considered exploratory
durvalumab plus tremelimumab (n=174) vs. Standard of Care (SoC) (n=118)
randomized controlled trial
durvalumab plus tremelimumab
durvalumab (10 mg/kg intravenously (i.v.) q2w for up to 12 months)plus tremelimumab (12 weeks durvalumab 20 mg/kg plus tremelimumab 1 mg/kg q4w then 34 weeks durvalumab 10 mg/kg q2w)
standard of care : erlotinib, gemcitabine or vinorelbine
1 of 3 SoC regimens: erlotinib (150 mg once a day by oral administration); gemcitabine (1000 mg/m2 i.v. over 30 minutes onDays 1, 8, and 15 of a 28-day cycle); or vinorelbine (30mg/m2 i.v. on Days 1, 8, 15, and 22 of a 28-day cycle. 69.2% (gemcitabine:41.5% vinorelbine: 22.0%), erlotinib: 29.7%
Dose reductions are not permitted for durvalumab or tremelimuab (mono and combi)
mNSCLC - L2 - PDL1 negative
patients with <25% of tumor cells (TCs) expressing programmed cell death ligand-1 (PD-L1). Patients who do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements
open label
205 study centers in 26 countries
P3/ two sided and no interim anaysis. Repartition between primary endpoint (0.04 OS and 0.01 PFS) for study B only
this study did not meet the primary endpoints of a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) and overall survival (OS).
atezolizumab alone (n=347) vs. docetaxel (n=337)
randomized controlled trial
atelozumab
Atezolizumab intravenous 1200 mg fixed dose every 3 weeks
docetaxel
docetaxel at 75 mg/m² every 3 weeks
No crossover to atezolizumab was allowed
mNSCLC - L2 - PDL1 positive
Patients with EGFR mutations or an ALK fusion oncogene were additionally required to have received previous tyrosine kinase inhibitor therapy.
open label
194 academic or community oncology centres in 31 countries
P3/ two sided no interim analysis planned. A splitting between the ITT population [a=3%] and the PDL1 TC1/2/3 or IC1/2/3 population [a=2%]) and reallocation 5% to OS SG TC2/3 and then TC3 was planned. an initial analysis with 850 patients was planned, but an amendement modified the population to 1225 before the analysis
Atezolizumab treatment significantly improve overall survival versus docetaxel in previously treated non-small-cell lung cancer, regardless of PD-L1 expression or histology
avelumab alone (n=264) vs. docetaxel (n=265)
randomized controlled trial
avelumab
10 mg/kg avelumab intravenously over 1 h once every 2 weeks, Dose modification of avelumab was not permitted.
docetaxel
75 mg/m docetaxel intravenously over 1 h every 3 weeks
No crossover to avelumab was permitted.
mNSCLC - L2 - PDL1 positive
Patients were not eligible if they had non-squamous cell NSCLC harbouring an EGFR or ALK mutation
open label
173 hospitals and cancer treatment centres in 31 countries
P3/ one sided and one interim analysis. Hierarchical testing procedure with secondary endpoints
Compared with docetaxel, avelumab did not improve overall survival in patients with platinum-treated PD-L1-positive NSCLC nor in ITT population, but had a favourable safety profile
durvalumab alone (n=62) vs. Standard of Care (SoC) (n=64)
randomized controlled trial
durvalumab
durvalumab (10 mg/kg intravenously (i.v.) q2w for up to 12 months)
standard of care : erlotinib, gemcitabine or vinorelbine
1 of 3 SoC regimens: erlotinib (150 mg once a day by oral administration); gemcitabine (1000 mg/m2 i.v. over 30 minutes onDays 1, 8, and 15 of a 28-day cycle); or vinorelbine (30mg/m2 i.v. on Days 1, 8, 15, and 22 of a 28-day cycle). Gemcitabine: 34.4% vinorelbine: 32.8% and erlotinib:31.3%.
Dose reductions are not permitted for durvalumab or tremelimuab (mono and combi)
mNSCLC - L2 - PDL1 positive
patients with >25% of tumor cells (TCs) expressing programmed cell death ligand-1 (PD-L1). Patients who do Not Have Known EGFR TK Activating Mutations or ALK Rearrangements
open label
205 study centers in 26 countries
P3/two sided and no interim anaysis. Repartition between primary endpoint (0.04 OS and 0.01 PFS) for study B only
this study did not meet the primary endpoints of a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) and overall survival (OS). the results of this study (A) were exploratory
pembrolizumab (10mg/kg) (n=151) vs. docetaxel (n=152)
randomized controlled trial
pembrolizumab 10 mg/kg
pembrolizumab 2 mg/kg intravenously over 30 min every 3 weeks for 24 months
docetaxel
docetaxel 75 mg/m² every 3 weeks for 24 months
patients in the docetaxel group were not permitted to cross over
mNSCLC - L2 - PDL1 positive
patients with appropriate tyrosine kinase inhibitor for those with an EGFR-sensitising mutation or ALK gene rearrangement were included
open-label
202 academic medical centres in 24 countries
P3-2/ one sided and two interim analysis. Repartition,reallocation and hierarchy between coprimary endpoints (4 in each arm)
Pembrolizumab prolongs overall survival and has a favourable benefi t-to-risk profi le in patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer (5 years results pooled 10 and 2mg)
pembrolizumab (10mg/kg) (n=346) vs. docetaxel (n=343)
randomized controlled trial
pembrolizumab 10 mg/kg
pembrolizumab 2 mg/kg intravenously over 30 min every 3 weeks for 24 months
docetaxel
docetaxel 75 mg/m² every 3 weeks for 24 months
patients in the docetaxel group were not permitted to cross over
mNSCLC - L2 - PDL1 positive
patients with appropriate tyrosine kinase inhibitor for those with an EGFR-sensitising mutation or ALK gene rearrangement were included
open-label
202 academic medical centres in 24 countries
P3-2/ one sided and two interim analysis. Repartition,reallocation and hierarchy between coprimary endpoints (4 in each arm)
Pembrolizumab prolongs overall survival and has a favourable benefit-to-risk profile in patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer. (5 years results pooled 10 and 2mg)
pembrolizumab (2mg/kg) (n=139) vs. docetaxel (n=152)
randomized controlled trial
pembrolizumab 2 mg/kg
pembrolizumab 2 mg/kg intravenously over 30 min every 3 weeks for 24 months
docetaxel
docetaxel 75 mg/m² every 3 weeks for 24 months
patients in the docetaxel group were not permitted to cross over
mNSCLC - L2 - PDL1 positive
patients with appropriate tyrosine kinase inhibitor for those with an EGFR-sensitising mutation or ALK gene rearrangement were included
open-label
202 academic medical centres in 24 countries
P3-2/ one sided and two interim analysis. Repartition,reallocation and hierarchy between coprimary endpoints (4 in each arm)
Pembrolizumab prolongs overall survival and has a favourable benefi t-to-risk profi le in patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer
pembrolizumab (2mg/kg) (n=344) vs. docetaxel (n=343)
randomized controlled trial
pembrolizumab 2 mg/kg
pembrolizumab 2 mg/kg intravenously over 30 min every 3 weeks for 24 months
docetaxel
docetaxel 75 mg/m² every 3 weeks for 24 months
patients in the docetaxel group were not permitted to cross over
mNSCLC - L2 - PDL1 positive
patients with appropriate tyrosine kinase inhibitor for those with an EGFR-sensitising mutation or ALK gene rearrangement were included
open-label
202 academic medical centres in 24 countries
P3-2/ one sided and two interim analysis, repartition,reallocation and hierarchy between coprimary endpoints (4 in each arm)
Pembrolizumab prolongs overall survival and has a favourable benefi t-to-risk profi le in patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer
nivolumab alone (n=292) vs. docetaxel (n=290)
randomized controlled trial
nivolumab
nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks, Reductions in the nivolumab dose were not permitted.
docetaxel
docetaxel at a dose of 75 mg per square meter of body-surface area every 3 weeks
non squamous - mNSCLC - L2 - all population
Patients with known EGFR mutation or ALK translocation were allowed to have received or be receiving an additional line of tyrosine kinase inhibitor therapy,
open-label
NA
P3/ two sided and one interim analysis. Hierarchical testing procedure with secondary endpoints
IA results (stopped)/this trial meet its primary endpoint of OS and secondary endpoint ORR but not PFS
nivolumab alone (n=135) vs. docetaxel (n=137)
randomized controlled trial
Nivolumab
nivolumab, at a dose of 3 mg per kilogram of body weight every 2 weeks, Reductions in the nivolumab dose were not permitted.
Docetaxel
docetaxel, at a dose of 75 mg per square meter of body-surface area every 3 weeks
squamous - mNSCLC - L2 - all population
no information about EGFR or ALT status
open label
NA
P3/ two sided and one interim analysis. Hierarchical testing procedure with secondary endpoints
IA results (stopped) / this trial meet its primary endpoint of OS and secondary endpoint ORR and PFS
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