STYLE
STYLE (NCT03449173): A Phase 2 Trial of Sunitinib in Patients With Type B3 Thymoma or Thymic Carcinoma in Second and Further Lines
Phase 2N = 44NCT03449173
- Population
- Patients with pretreated advanced or recurrent type B3 thymoma or thymic carcinoma in second and further lines; 12 with thymoma and 32 with thymic carcinoma enrolled.
- Design
- Multicentre, Simon two-stage phase 2 trial, March 2017 to January 2022. Patients with pretreated type B3 thymoma or thymic carcinoma were enrolled in two cohorts and assessed separately. Sunitinib 50 mg daily for 4 weeks followed by a 2-week rest (schedule 4/2) until progression or unacceptable toxicity. Primary endpoint: objective response rate. Secondary endpoints: progression-free survival, overall survival, disease control rate and safety.
- Primary endpoint
- ORR
- Arms
- Type B3 thymoma cohort (experimental, n = 12): Sunitinib 50 mg daily for 4 weeks, then 2 weeks of rest
- Thymic carcinoma cohort (experimental, n = 32): Sunitinib 50 mg daily for 4 weeks, then 2 weeks of rest
- People
- Proto C
Show the numbers
| Endpoint | Analysis | Type B3 thymoma cohort / Thymic carcinoma cohort | Control | Effect |
|---|---|---|---|---|
| ORRThymoma cohort at stage 1 (n=12) and thymic carcinoma cohort at stage 2 | primaryProto 2023 | 0% | — | The intervals printed are 90% confidence intervals: 0.0-22.1 for the thymoma cohort at stage 1, after which the thymoma cohort was closed, and 9.0-40.4 for thymic carcinoma at stage 2, where the primary endpoint was met. In thymic carcinoma the stage 1 response rate was 16.7% (90% CI 3.1-43.8). In the intention-to-treat analysis, disease control rate was 91.7% (95% CI 61.5-99.8) in thymoma and 89.3% (95% CI 71.8-97.7) in thymic carcinoma. Grade 3 or worse treatment-related adverse events: 25.0% in thymoma and 51.6% in thymic carcinoma. |
| PFSEnrolled patients by cohort (12 thymoma, 32 thymic carcinoma); analysis population not named in the abstract | primaryProto 2023 | median 7.7 months (2.4–45.5) | — | — |
| OSEnrolled patients by cohort (12 thymoma, 32 thymic carcinoma); analysis population not named in the abstract | primaryProto 2023 | median 47.9 months | — | For the thymoma cohort the printed 95% confidence interval is 4.5 to not reached, so no interval is entered. |
| Endpoint | Analysis | Type B3 thymoma cohort / Thymic carcinoma cohort | Control | Effect |
|---|---|---|---|---|
| ORRThymoma cohort at stage 1 (n=12) and thymic carcinoma cohort at stage 2 | primaryProto 2023 | 0% | — | The intervals printed are 90% confidence intervals: 0.0-22.1 for the thymoma cohort at stage 1, after which the thymoma cohort was closed, and 9.0-40.4 for thymic carcinoma at stage 2, where the primary endpoint was met. In thymic carcinoma the stage 1 response rate was 16.7% (90% CI 3.1-43.8). In the intention-to-treat analysis, disease control rate was 91.7% (95% CI 61.5-99.8) in thymoma and 89.3% (95% CI 71.8-97.7) in thymic carcinoma. Grade 3 or worse treatment-related adverse events: 25.0% in thymoma and 51.6% in thymic carcinoma. |
| PFSEnrolled patients by cohort (12 thymoma, 32 thymic carcinoma); analysis population not named in the abstract | primaryProto 2023 | median 7.7 months (2.4–45.5) | — | — |
| OSEnrolled patients by cohort (12 thymoma, 32 thymic carcinoma); analysis population not named in the abstract | primaryProto 2023 | median 47.9 months | — | For the thymoma cohort the printed 95% confidence interval is 4.5 to not reached, so no interval is entered. |
- Type B3 thymoma cohort (experimental)
- Thymic carcinoma cohort (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Type B3 thymoma cohort | Thymic carcinoma cohort |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 6 | 58.3% | 62.3% |
| 11 | 37.1% | 42.0% |
| 17 | 21.6% | 26.2% |
| 22 | 13.8% | 17.7% |
- Type B3 thymoma cohort (experimental)
- Thymic carcinoma cohort (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Type B3 thymoma cohort | Thymic carcinoma cohort |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 30 | 64.8% | 47.3% |
| 60 | 42.0% | 22.4% |
| 90 | 27.2% | 10.6% |
| 120 | 17.6% | 5.0% |