| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo plus SoC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| sintillimab plus SoC vs. placebo plus SoC | 1 | none | inconclusive results for: DCR; DOR; AE (any grade); AE (grade 3-4); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); Diarrhoea TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Anaemia AE (grade 3-4); Asthenia AE (grade 3-4); Constipation AE (grade 3-4); Decreased appetite AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Nausea AE (grade 3-4); Pyrexia AE (grade 3-4); Vomiting AE (grade 3-4) | suggested 39 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 2.5-fold increase in objective responses (ORR) but the degree if certainty is unassessable suggested 69 % decrease in AE leading to death (grade 5) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| cemiplimab vs. Standard of Care (SoC) | 1 | none | inconclusive results for: DOR; AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); Colitis TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Maculopapular rash TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Rash TRAE (grade 3-4); hepatitis (Autoimmune) AE (grade 3-4); Acute kidney injury AE (grade 3-4); Alopecia AE (grade 3-4); Arthralgia AE (grade 3-4); Asthenia AE (grade 3-4); Back pain AE (grade 3-4); Blood creatinine increased AE (grade 3-4); Constipation AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Febrile neutropenia AE (grade 3-4); Hypertension AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Increased Lipase Level AE (grade 3-4); myocarditis AE (grade 3-4); Nausea AE (grade 3-4); Pancytopenia (AE grade 3-4); Peripheral neuropathy AE (grade 3-4); Peripheral sensory neuropathy AE (grade 3-4); Pneumonia AE (grade 3-4); Pneumonitis AE (grade 3-4); Rash AE (grade 3-4); Rash maculopapular AE (grade 3-4); Stomatitis AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4) | statistically conclusive 32 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 82 % decrease in AE (any grade) but the degree if certainty is unassessable suggested 81 % decrease in AE (grade 3-4) but the degree if certainty is unassessable suggested 97 % decrease in Anaemia AE (grade 3-4) but the degree if certainty is unassessable suggested 90 % decrease in Leucopenia AE (grade 3-4) but the degree if certainty is unassessable suggested 95 % decrease in Neutropenia AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| durvalumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Alopecia AE (grade 3-4); Asthenia AE (grade 3-4); Back pain AE (grade 3-4); Constipation AE (grade 3-4); Cough AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Nausea AE (grade 3-4); Pruritus AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4) | suggested 44 % decrease in STRAE (any grade) but the degree if certainty is unassessable suggested 52 % decrease in STRAE (grade 3-4) but the degree if certainty is unassessable suggested 76 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 66 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 99 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 88 % decrease in Asthenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 98 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 84 % decrease in Anaemia AE (grade 3-4) but the degree if certainty is unassessable suggested 93 % decrease in Neutropenia AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mNSCLC - L1 - PDL1 negative metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - PDL1 negative | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus pemetrexed plus platin | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab plus SoC vs. pemetrexed plus platin | 1 | none | inconclusive results for: deaths (OS); STRAE (any grade); STRAE (grade 3-4); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Nausea TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mNSCLC - L1 - PDL1 positive metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - PDL1 positive | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus Standard of Care (SoC) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab alone vs. Standard of Care (SoC) | 3 | none | inconclusive results for: deaths (OS); deaths (OS) (extension); DOR; DOR (extension); objective responses (ORR); objective responses (ORR) (extension); AE (any grade); AE leading to death (grade 5); SAE (any grade); TRAE leading to death (grade 5); Colitis TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Rash TRAE (grade 3-4); Asthenia AE (grade 3-4); Constipation AE (grade 3-4); Cough AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Hypertension AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Leucopenia AE (grade 3-4); Nausea AE (grade 3-4); Pancytopenia (AE grade 3-4); Pneumonia AE (grade 3-4); Pyrexia AE (grade 3-4); Sepsis AE (grade 3-4); Vomiting AE (grade 3-4) | suggested 28 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 23 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable suggested 61 % decrease in AE (grade 3-4) but the degree if certainty is unassessable suggested 50 % decrease in STRAE (any grade) but the degree if certainty is unassessable suggested 73 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 81 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 92 % decrease in Anaemia AE (grade 3-4) but the degree if certainty is unassessable suggested 97 % decrease in Neutropenia AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| cemiplimab vs. Standard of Care (SoC) | 1 | none | inconclusive results for: DOR | suggested 43 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 46 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable suggested 2.5-fold increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| durvalumab alone vs. Standard of Care (SoC) | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR); AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); SAE (any grade); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade) | suggested 62 % decrease in STRAE (any grade) but the degree if certainty is unassessable suggested 79 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 64 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab alone vs. Standard of Care (SoC) | 2 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR); STRAE (any grade); STRAE (grade 3-4); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Alopecia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; Hypothyroidism TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Maculopapular rash TRAE (grade 3-4); Mucosal inflammation TRAE (grade 3-4); Nausea TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Peripheral oedema TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Rash TRAE (grade 3-4); Renal and urinary disorders TRAE (grade 3-4) ; Respiratory, thoracic and mediastinal disorders TRAE (grade 3-4) ; Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Stomatitis TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Increase AST AE (grade 3-4) | suggested 80 % decrease in TRAE (any grade) but the degree if certainty is unassessable suggested 79 % decrease in TRAE (grade 3-4) but the degree if certainty is unassessable suggested 98 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 80 % decrease in Fatigue TRAE (grade 3-4) but the degree if certainty is unassessable suggested 95 % decrease in Leucopenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 98 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab alone vs. Standard of Care (SoC) | 4 | statistically conclusive 26 % decrease in deaths (OS) suggested 28 % decrease in deaths (OS) (extension) statistically conclusive 26 % decrease in progression or deaths (PFS) suggested 78 % decrease in TRAE (any grade) suggested 70 % decrease in TRAE (grade 3-4) suggested 94 % decrease in Anaemia TRAE (grade 3-4) suggested 90 % decrease in Nausea TRAE (grade 3-4) suggested 98 % decrease in Neutropenia TRAE (grade 3-4) suggested 92 % decrease in Thrombocytopenia TRAE (grade 3-4) | inconclusive results for: PFS (extension); DOR; DOR (extension); objective responses (ORR); objective responses (ORR) (extension); STRAE (any grade); STRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Colitis TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Myalgia TRAE (grade 3-4); Myocarditis TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Peripheral sensory neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Pyrexia TRAE (grade 3-4); Rash TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | suggested 95 % decrease in Leucopenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
mNSCLC - L1 - TMB>10Mb metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) mNSCLC - L1 - TMB10Mb | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
non squamous - mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) non squamous cell - mNSCLC - L1 non squamous - mNSCLC - L1 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus atezolizumab plus carboplatin plus nab-paclitaxel | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus carboplatin plus nab-paclitaxel vs. atezolizumab plus carboplatin plus nab-paclitaxel | 1 | none | inconclusive results for: AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); SAE (any grade); STRAE (any grade); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Nausea TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Vomiting TRAE (grade 3-4); hepatitis (Autoimmune) AE (grade 3-4); Abdominal pain AE (grade 3-4); Agranulocytosis (AE grade 3-4); Alopecia AE (grade 3-4); Anaemia AE (grade 3-4); Arthralgia AE (grade 3-4); Asthenia AE (grade 3-4); Back pain AE (grade 3-4); Blood creatinine increased AE (grade 3-4); Colitis AE (grade 3-4); Constipation AE (grade 3-4); Cough AE (grade 3-4); Decreased appetite AE (grade 3-4); Diabetes mellitus AE (grade 3-4); Diarrhoea AE (grade 3-4); Dizziness AE (grade 3-4); Dry skin AE (grade 3-4); Dysgeusia AE (grade 3-4); Dyspnoea AE (grade 3-4); Epistaxis AE (grade 3-4); Fatigue AE (grade 3-4); Febrile neutropenia AE (grade 3-4); Gastritis AE (grade 3-4); Headache AE (grade 3-4); Hypertension AE (grade 3-4); Hyperthyroidism AE (grade 3-4); Hypothyroidism AE (grade 3-4); Increase AST AE (grade 3-4); Increased ALT AE (grade 3-4); Infusion-related reaction AE (grade 3-4); Leucopenia AE (grade 3-4); Myalgia AE (grade 3-4); Nausea AE (grade 3-4); Neutropenia AE (grade 3-4); Pancytopenia (AE grade 3-4); Paraesthesia AE (grade 3-4); Peripheral neuropathy AE (grade 3-4); Peripheral oedema AE (grade 3-4); Peripheral sensory neuropathy AE (grade 3-4); Pneumonia AE (grade 3-4); Pneumonitis AE (grade 3-4); Pruritus AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Rash maculopapular AE (grade 3-4); Sepsis AE (grade 3-4); Stomatitis AE (grade 3-4); Thrombocytopenia AE (grade 3-4); Vomiting AE (grade 3-4); Weight decreased AE (grade 3-4) | statistically conclusive 20 % decrease in deaths (OS) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus bevacizumab plus carboplatin and paclitaxel | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus bevacizumab plus carboplatin plus paclitaxel vs. bevacizumab plus carboplatin and paclitaxel | 1 | none | inconclusive results for: DOR; AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); SAE (any grade); STRAE (any grade); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Epistaxis TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Febrile neutropenia TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hypertension TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Myalgia TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Paraesthesia TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Rash TRAE (grade 3-4); Sepsis TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | suggested 24 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 39 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable suggested 95 % increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus carboplatin plus paclitaxel vs. bevacizumab plus carboplatin and paclitaxel | 1 | none | inconclusive results for: deaths (OS); progression or deaths (PFS); DOR; objective responses (ORR) | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
non squamous - mNSCLC - L1 - Wild Type (WT) metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) non squamous cell - mNSCLC - L1 non squamous - mNSCLC - L1 - Wild Type (WT) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus bevacizumab plus carboplatin and paclitaxel | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus bevacizumab plus carboplatin plus paclitaxel vs. bevacizumab plus carboplatin and paclitaxel | 2 | statistically conclusive 42 % decrease in progression or deaths (PFS) | inconclusive results for: DOR | statistically conclusive 22 % decrease in deaths (OS) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus carboplatin plus nab-paclitaxel | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus carboplatin plus nab-paclitaxel vs. carboplatin plus nab-paclitaxel | 1 | none | inconclusive results for: DOR | statistically conclusive 21 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 2.1-fold increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus pemetrexed plus platin | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus pemetrexed and platin vs. pemetrexed plus platin | 1 | none | inconclusive results for: deaths (OS); DOR; AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); SAE (any grade); STRAE (any grade); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); Colitis TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Rash TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4) | suggested 86 % increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab and pemetrexed plus platin vs. pemetrexed plus platin | 1 | none | inconclusive results for: deaths (OS); deaths (OS) (extension); DOR; DOR (extension); STRAE (any grade); STRAE (grade 3-4); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade); TRAE leading to discontinuation (grade 3-4); Acute kidney injury TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Blood creatinine increased TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Dizziness TRAE (grade 3-4); Dysgeusia TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Febrile neutropenia TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increase AST TRAE (grade 3-4); Increased ALT TRAE (grade 3-4); Increased lacrimation (TRAE grade 3-4); Infusion-related reactions TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Nausea TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Pancytopenia TRAE (grade 3-4); Peripheral oedema TRAE (grade 3-4); Pneumonia TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Sepsis TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4); Stomatitis TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | suggested 46 % decrease in PFS (extension) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo plus SoC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab plus SoC vs. placebo plus SoC | 1 | none | inconclusive results for: DOR; AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Colitis TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Anaemia AE (grade 3-4); Asthenia AE (grade 3-4); Constipation AE (grade 3-4); Cough AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Lacrimation increased AE (grade 3-4); Nausea AE (grade 3-4); Neutropenia AE (grade 3-4); Peripheral oedema AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Thrombocytopenia AE (grade 3-4); Vomiting AE (grade 3-4) | statistically conclusive 51 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 44 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 52 % decrease in PFS (extension) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
squamous - mNSCLC - L1 - all population metastatic/advanced NSCLC (mNSCLC) - 1st line (L1) squamous cell - mNSCLC - L1 squamous - mNSCLC - L1 - all population | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus carboplatin plus nab-paclitaxel | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus carboplatin plus nab-paclitaxel vs. carboplatin plus nab-paclitaxel | 1 | none | inconclusive results for: deaths (OS); DOR; AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); SAE (any grade); STRAE (any grade); TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Arthralgia TRAE (grade 3-4); Asthenia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Constipation TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Febrile neutropenia TRAE (grade 3-4); Guillain-Barré syndrome TRAE (grade 3-4); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Myalgia TRAE (grade 3-4); Myositis TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Peripheral sensory neuropathy TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Rash TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | suggested 42 % increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo plus SoC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab plus SoC vs. placebo plus SoC | 1 | none | inconclusive results for: DOR; AE (any grade); AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (any grade); AE leading to treatment discontinuation (grade 3-4); TRAE leading to death (grade 5); hepatitis (Autoimmune) AE (grade 3-4); Alopecia AE (grade 3-4); Anaemia AE (grade 3-4); Arthralgia AE (grade 3-4); Asthenia AE (grade 3-4); Colitis AE (grade 3-4); Constipation AE (grade 3-4); Cough AE (grade 3-4); Decreased appetite AE (grade 3-4); Diarrhoea AE (grade 3-4); Dyspnoea AE (grade 3-4); Epistaxis AE (grade 3-4); Fatigue AE (grade 3-4); Hyperthyroidism AE (grade 3-4); Hypophysitis AE (grade 3-4); Hypothyroidism AE (grade 3-4); Infusion-related reaction AE (grade 3-4); Myalgia AE (grade 3-4); Nausea AE (grade 3-4); Neutropenia AE (grade 3-4); Peripheral neuropathy AE (grade 3-4); Pneumonitis AE (grade 3-4); Pyrexia AE (grade 3-4); Severe skin reactions AE (grade 3-4); Thrombocytopenia AE (grade 3-4); Thyroiditis AE (grade 3-4); Vomiting AE (grade 3-4) | statistically conclusive 36 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 2.2-fold increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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