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Study |
study type
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Pathology | T1 | T0 | Patients | sample sizes | ROB |
Results |
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| KEYNOTE-042 (PDL1>20%), 2019 NCT02220894 | RCT | mNSCLC - L1 - PDL1 positive | pembrolizumab | platinium based chemotherapy | previously untreated, locally advanced or metastatic non-small-cell lung cancer with a PD-L1 TPS of 20% or greater | 413 / 405 | some concern
| conclusif | - demonstrated 23 % decrease in deaths (OS) (PE)
- suggested 25 % decrease in deaths (OS) (extension)
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| KEYNOTE-042 (PDL1>1%), 2019 NCT02220894 | RCT | mNSCLC - L1 - PDL1 positive | pembrolizumab | platinium based chemotherapy | previously untreated, locally advanced or metastatic non-small-cell lung cancer with a PD-L1 TPS of 1% or greater | 637 / 637 | some concern
| conclusif | - demonstrated 19 % decrease in deaths (OS) (PE)
- suggested 20 % decrease in deaths (OS) (extension)
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| KEYNOTE-042 (PDL1>50%), 2019 NCT02220894 | RCT | mNSCLC - L1 - PDL1 positive | pembrolizumab | platinium based chemotherapy | previously untreated, locally advanced or metastatic non-small-cell lung cancer with a PD-L1 TPS of 50% or greater | 299 / 300 | some concern
| conclusif | - demonstrated 31 % decrease in deaths (OS) (PE)
- suggested 2 % decrease in deaths (OS) (extension)
- suggested 19 % decrease in progression or deaths (PFS)
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| KEYNOTE-024 (PDL1>50%), 2016 NCT02142738 | RCT | mNSCLC - L1 - PDL1 positive | Pembrolizumab | ICC platinum-based chemotherapies regimens | patients who had previously untreated advanced stage IV NSCLC with PD-L1 expression on at least 50% of tumor cells | 154 / 151 | some concern
| conclusif | - demonstrated 40 % decrease in deaths (OS) (PE)
- demonstrated 50 % decrease in progression or deaths (PFS) (PE)
- suggested 38 % decrease in deaths (OS) (extension)
- suggested 50 % decrease in PFS (extension)
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| KEYNOTE-021, 2016 NCT02039674 | RCT | non squamous - mNSCLC - L1 - Wild Type (WT) | pembrolizumab with carboplatin plus pemetrexed | carboplatin plus pemetrexed | patients with stage IIIB/IV, chemotherapy-naive, nonsquamous non-small-cell lung cancer | 60 / 63 | some concern
| conclusif | - demonstrated 47 % decrease in progression or deaths (PFS) (PE)
- suggested 46 % decrease in PFS (extension)
- demonstrated 2.1-fold increase in objective responses (ORR) (PE)
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| KEYNOTE-189, 2018 NCT02578680 | RCT | non squamous - mNSCLC - L1 - Wild Type (WT) | pembrolizumab plus pemetrexed plus platine | placebo plus pemetrexed plus platine | participants with advanced or metastatic nonsquamous non-small cell lung cancer who have not previously received systemic therapy for advanced disease | 410 / 206 | low
| conclusif | - demonstrated 51 % decrease in deaths (OS) (PE)
- demonstrated 48 % decrease in progression or deaths (PFS) (PE)
- suggested 44 % decrease in deaths (OS) (extension)
- suggested 52 % decrease in PFS (extension)
more...
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| KEYNOTE-407, 2018 NCT02775435 | RCT | squamous - mNSCLC - L1 - all population | pembrolizumab plus platine and (nab)paclitaxel | placebo plus platine and (nab)paclitaxel | patients with confirmed stage IV squamous NSCLC who had received no previous systemic therapy for metastatic disease | 278 / 281 | low
| conclusif | - demonstrated 36 % decrease in deaths (OS) (PE)
- demonstrated 44 % decrease in progression or deaths (PFS) (PE)
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| KEYNOTE-010 (P:10 mg/kg ; PDL1>50%), 2016 NCT01905657 | RCT | mNSCLC - L2 - PDL1 positive | pembrolizumab 10 mg/kg | docetaxel | patients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 50% of tumour cells | 151 / 152 | high
| conclusif | - demonstrated 50 % decrease in deaths (OS) (PE)
- demonstrated 41 % decrease in progression or deaths (PFS) (PE)
- suggested 45 % decrease in deaths (OS) (extension)
- suggested 43 % decrease in PFS (extension)
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| KEYNOTE-010 (P:10 mg/kg), 2016 NCT01905657 | RCT | mNSCLC - L2 - PDL1 positive | pembrolizumab 10 mg/kg | docetaxel | patients with previously treated (one line or more) non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells | 346 / 343 | high
| conclusif | - demonstrated 39 % decrease in deaths (OS) (PE)
- suggested 21 % decrease in progression or deaths (PFS) (PE)
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| KEYNOTE-010 (P: 2mg/kg ; PDL1>50%), 2016 NCT01905657 | RCT | mNSCLC - L2 - PDL1 positive | pembrolizumab 2 mg/kg | docetaxel | patients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 50% of tumour cells | 139 / 152 | high
| conclusif | - demonstrated 46 % decrease in deaths (OS) (PE)
- demonstrated 41 % decrease in progression or deaths (PFS) (PE)
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| KEYNOTE-010 (P: 2mg/kg), 2016 NCT01905657 | RCT | mNSCLC - L2 - PDL1 positive | pembrolizumab 2 mg/kg | docetaxel | patients with previously treated non-small-cell lung cancer with PD-L1 expression on at least 1% of tumour cells | 344 / 343 | high
| conclusif | - demonstrated 29 % decrease in deaths (OS) (PE)
- inconclusive 12 % decrease in progression or deaths (PFS) (PE)
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