| Statistically conclusive or suggested result | Inconclusive results | Uncertain results | Safety results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Extensive stage SCLC (Es-SCLC) - maintenance (M) Extensive stage SCLC (Es-SCLC) Extensive stage SCLC (Es-SCLC) - maintenance (M) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab alone vs. placebo | 1 | none | inconclusive results for: deaths (OS); DOR; TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade) | suggested 33 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable suggested 2.9-fold increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nivolumab plus ipilimumab vs. placebo | 1 | none | inconclusive results for: deaths (OS); DOR; TRAE (any grade); TRAE (grade 3-4); TRAE leading to death (grade 5); TRAE leading to discontinuation (any grade) | suggested 28 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable suggested 2.3-fold increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Extensive stage SCLC (Es-SCLC) - 1st Line (L1) Extensive stage SCLC (Es-SCLC) Extensive stage SCLC (Es-SCLC) - 1st Line (L1) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus etoposide plus platin | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| durvalumab plus etoposide and platin vs. etoposide plus platin | 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); SAE (any grade); SAE (grade 3-4); STRAE (any grade); 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); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Arthritis TRAE (grade 3-4); Asthenia 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); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increased lipase level TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Myocarditis TRAE (grade 3-4); Nausea TRAE (grade 3-4); Paraesthesia TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Thyroiditis 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); Febrile neutropenia AE (grade 3-4); Headache AE (grade 3-4); Hypertension AE (grade 3-4); Hyperthyroidism AE (grade 3-4); Increased Lipase Level AE (grade 3-4); Leucopenia AE (grade 3-4); Nausea AE (grade 3-4); Pneumonia AE (grade 3-4); Pruritus 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 27 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 25 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 20 % decrease in PFS (extension) but the degree if certainty is unassessable suggested 22 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable suggested 64 % increase in objective responses (ORR) but the degree if certainty is unassessable suggested 49 % decrease in STRAE (grade 3-4) but the degree if certainty is unassessable suggested 48 % decrease in Anaemia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 37 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 55 % decrease in Anaemia AE (grade 3-4) but the degree if certainty is unassessable suggested 36 % decrease in Neutropenia AE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| durvalumab plus tremelimumab plus SoC vs. etoposide plus platin | 1 | none | inconclusive results for: 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); 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); Adrenal insufficiency TRAE (grade 3-4); 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); Diabetes TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Fatigue TRAE (grade 3-4); Febrile neutropenia TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Increased lipase level TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Myocarditis TRAE (grade 3-4); Nausea TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Paraesthesia TRAE (grade 3-4); Pneumonitis TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Thyroiditis TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Alopecia AE (grade 3-4); Anaemia 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); Febrile neutropenia AE (grade 3-4); Headache AE (grade 3-4); Hypertension AE (grade 3-4); Hyperthyroidism AE (grade 3-4); Increased Lipase Level AE (grade 3-4); Leucopenia AE (grade 3-4); Nausea AE (grade 3-4); Neutropenia AE (grade 3-4); Pneumonia AE (grade 3-4); Pruritus AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Thrombocytopenia AE (grade 3-4); Vomiting AE (grade 3-4) | suggested 18 % decrease in deaths (OS) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus placebo plus SoC | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| atezolizumab plus SoC vs. placebo plus SoC | 1 | none | inconclusive results for: DOR; DOR (extension); objective responses (ORR); objective responses (ORR) (extension); 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); Acute kidney injury TRAE (grade 3-4); Adrenal insufficiency TRAE (grade 3-4); Alopecia TRAE (grade 3-4); Anaemia 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); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Infusion-related reactions TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Nausea TRAE (grade 3-4); Nephritis TRAE (grade 3-4); Neutropenia TRAE (grade 3-4); Pancreatitis TRAE (grade 3-4); Pancytopenia TRAE (grade 3-4); Peripheral neuropathy TRAE (grade 3-4); Pneumonia 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) | statistically conclusive 30 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 24 % decrease in deaths (OS) (extension) but the degree if certainty is unassessable suggested 23 % decrease in PFS (extension) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ipilimumab plus SoC vs. placebo plus SoC | 1 | none | inconclusive results for: deaths (OS); DOR; objective responses (ORR); 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); Alopecia TRAE (grade 3-4); Anaemia TRAE (grade 3-4); Colitis TRAE (grade 3-4); Decreased appetite TRAE (grade 3-4); Diarrhoea TRAE (grade 3-4); Endocrine disorders TRAE (grade 3-4) ; Fatigue TRAE (grade 3-4); Gastrointestinal disorders TRAE (grade 3-4) ; Hepatobiliary disorders 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); Nausea TRAE (grade 3-4); Nervous system disorders TRAE (grade 3-4); Peripheral sensory neuropathy TRAE (grade 3-4); Pruritus TRAE (grade 3-4); Rash TRAE (grade 3-4); Skin and subcutaneous tissue disorders TRAE (grade 3-4) ; Thrombocytopenia TRAE (grade 3-4); Vomiting TRAE (grade 3-4) | suggested 15 % decrease in progression or deaths (PFS) but the degree if certainty is unassessable suggested 60 % decrease in Leucopenia TRAE (grade 3-4) but the degree if certainty is unassessable suggested 46 % decrease in Neutropenia TRAE (grade 3-4) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| pembrolizumab plus SoC vs. placebo plus SoC | 1 | none | inconclusive results for: DOR; AE (grade 3-4); AE leading to death (grade 5); AE leading to treatment discontinuation (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); 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); Hepatitis TRAE (grade 3-4); Hyperthyroidism TRAE (grade 3-4); Hypophysitis TRAE (grade 3-4); Hypothyroidism TRAE (grade 3-4); Leucopenia TRAE (grade 3-4); Myocarditis 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); Pneumonitis TRAE (grade 3-4); Severe skin reaction TRAE (grade 3-4); Thrombocytopenia TRAE (grade 3-4); Uveitis TRAE (grade 3-4); Vomiting TRAE (grade 3-4); Alopecia AE (grade 3-4); Anaemia 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); Dizziness AE (grade 3-4); Dyspnoea AE (grade 3-4); Fatigue AE (grade 3-4); Headache AE (grade 3-4); Hypothyroidism AE (grade 3-4); Leucopenia AE (grade 3-4); Nausea AE (grade 3-4); Neutropenia AE (grade 3-4); Peripheral oedema AE (grade 3-4); Pneumonia AE (grade 3-4); Pruritus AE (grade 3-4); Pyrexia AE (grade 3-4); Rash AE (grade 3-4); Thrombocytopenia AE (grade 3-4); Vomiting AE (grade 3-4) | suggested 20 % decrease in deaths (OS) but the degree if certainty is unassessable suggested 49 % increase in objective responses (ORR) but the degree if certainty is unassessable | - | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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