Table 4.
Operating characteristics for Cohorts A and B.
| Row 1: (True % DLT, True % Efficacy); Row 2: % Selection as OTC; Row 3: Average Participants Treated. | Immune Agent 2 | Cohort A | Cohort B | ||||
|---|---|---|---|---|---|---|---|
| Cisplatin, Pemetrexed (mg/m2) | Cisplatin, Gemcitabine (mg/m2) | ||||||
| 25, 150 | 50, 375 | 75, 500 | 25, 400 | 50, 800 | 75, 1200 | ||
| Scenario 1: All doses are safe. Intermediate chemo dose maximizes efficacy. | Dose 1 | (0.03, 0.35) | (0.08, 0.50) | (0.20, 0.45) | (0.03, 0.35) | (0.08, 0.50) | (0.20, 0.45) |
| 11.4 | 33.4 | 18.7 | 13.0 | 30.3 | 18.1 | ||
| 3.9 | 5.8 | 4.2 | 3.2 | 4.4 | 2.7 | ||
| 0 | (0.01, 0.25) | (0.05, 0.40) | (0.15, 0.35) | (0.01, 0.25) | (0.05, 0.40) | (0.15, 0.35) | |
| 4.7 | 21.5 | 10.2 | 6.7 | 20.8 | 11.1 | ||
| 3.1 | 5.3 | 3.7 | 2.6 | 4.3 | 2.6 | ||
| Scenario 2: All doses are safe. More chemo yields better efficacy. | Dose 1 | (0.03, 0.55) | (0.08, 0.67) | (0.20, 0.78) | (0.03, 0.55) | (0.08, 0.67) | (0.20, 0.78) |
| 9.5 | 19.9 | 30.9 | 14.1 | 21.0 | 24.6 | ||
| 3.5 | 4.4 | 5.0 | 3.1 | 3.3 | 3.3 | ||
| 0 | (0.01, 0.45) | (0.05, 0.57) | (0.15, 0.68) | (0.01, 0.45) | (0.05, 0.57) | (0.15, 0.68) | |
| 4.3 | 13.2 | 22.2 | 5.7 | 16.5 | 18.1 | ||
| 2.9 | 4.7 | 4.5 | 2.3 | 4.2 | 3.1 | ||
| Scenario 3: Highest chemo dose with immune agent 2 is unsafe. More chemo yields better efficacy. | Dose 1 | (0.22, 0.55) | (0.27, 0.67) | (0.32, 0.78) | (0.22, 0.55) | (0.27, 0.67) | (0.32, 0.78) |
| 22.2 | 16 | 5.9 | 20 | 17.8 | 6.7 | ||
| 5.2 | 3.9 | 1.5 | 3.8 | 3.2 | 1.3 | ||
| 0 | (0.20, 0.45) | (0.25, 0.57) | (0.30, 0.68) | (0.20, 0.45) | (0.25, 0.57) | (0.30, 0.68) | |
| 12.7 | 28 | 15.2 | 12.2 | 28.3 | 14.7 | ||
| 4.2 | 6.5 | 3.8 | 3.1 | 5.6 | 2.7 | ||
| Scenario 4: Highest chemo dose with immune agent 2 is unsafe. Intermediate chemo dose maximizes efficacy. | Dose 1 | (0.22, 0.60) | (0.27, 0.85) | (0.32, 0.70) | (0.22, 0.60) | (0.27, 0.85) | (0.32, 0.70) |
| 9 | 19.3 | 1.7 | 8.6 | 15.8 | 1.7 | ||
| 3.7 | 4.2 | 1 | 2.5 | 2.7 | 0.7 | ||
| 0 | (0.20, 0.55) | (0.25, 0.83) | (0.30, 0.68) | (0.20, 0.55) | (0.25, 0.83) | (0.30, 0.68) | |
| 6.7 | 57.5 | 5.8 | 10.3 | 58.9 | 4.5 | ||
| 3.3 | 9.2 | 2.5 | 2.7 | 8.6 | 1.6 | ||
| Scenario 5: Highest chemo dose with/out immune agent 2 is unsafe. Intermediate chemo dose maximizes efficacy. | Dose 1 | (0.10, 0.70) | (0.22, 0.85) | (0.42, 0.70) | (0.10, 0.70) | (0.22, 0.85) | (0.42, 0.70) |
| 12.6 | 26.8 | 1.6 | 10.9 | 23.2 | 1.7 | ||
| 5.2 | 4.2 | 1.2 | 2.7 | 3.5 | 0.8 | ||
| 0 | (0.08, 0.65) | (0.20, 0.83) | (0.40, 0.68) | (0.08, 0.65) | (0.20, 0.83) | (0.40, 0.68) | |
| 7.5 | 47.5 | 4 | 9.7 | 50.7 | 3.8 | ||
| 3.5 | 8.3 | 2.5 | 2.7 | 7.8 | 1.5 | ||
| Scenario 6: Two cohorts have different safety and efficacy profiles. | Dose 1 | (0.03, 0.55) | (0.08, 0.67) | (0.20, 0.78) | (0.10, 0.70) | (0.22, 0.85) | (0.42, 0.70) |
| 7.4 | 20.5 | 33.7 | 13.5 | 19.6 | 2 | ||
| 2.6 | 4.6 | 4.6 | 2.8 | 3.1 | 0.8 | ||
| 0 | (0.01, 0.45) | (0.05, 0.57) | (0.15, 0.68) | (0.08, 0.65) | (0.20, 0.83) | (0.40, 0.68) | |
| 3 | 13.6 | 21.8 | 11 | 49.3 | 4.6 | ||
| 3.2 | 4.6 | 5.5 | 2.7 | 7.2 | 1.6 | ||