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Table 7 Summary of trial-level sensitivity analysis (Spearman correlation)

From: Validating ORR and PFS as surrogate endpoints in phase II and III clinical trials for NSCLC patients: difference exists in the strength of surrogacy in various trial settings

Sensitivity Analysis

No. of trials

rs

95%CI

ΔORR ~ HR of OS

 Line of therapy

  First-line

39

0.685

0.471, 0.822

   ≥ 2nd-line

64

0.342

0.103, 0.544

 Phase of trial

  Phase II

60

0.399

0.163, 0.591

  Phase III

52

0.511

0.277, 0.688

 Masking

  Double-blind

35

0.259

−0.081, 0.545

  Open-label

76

0.536

0.354, 0.680

Overall

112

0.462

0.303, 0.597

ΔORR ~ HR of PFS

 Line of therapy

  First-line

36

0.767

0.587, 0.875

   ≥ 2nd-line

68

0.787

0.675, 0.863

 Phase of trial

  Phase II

60

0.792

0.674, 0.870

  Phase III

54

0.673

0.495, 0.797

 Masking

  Double-blind

36

0.703

0.487, 0.838

  Open-label

77

0.789

0.672, 0.852

Overall

114

0.764

0.686, 0.861

HR of PFS ~ HR of OS

 Line of therapy

  First-line

48

0.768

0.621, 0.863

   ≥ 2nd-line

81

0.550

0.377, 0.686

 Phase of trial

  Phase II

62

0.475

0.258, 0.647

  Phase III

72

0.650

0.492, 0.766

 Masking

  Double-blind

42

0.676

0.469, 0.813

  Open-label

95

0.570

0.417, 0.692

Overall

138

0.584

0.462, 0.684