STELLAR
Tumour Treating Fields in combination with pemetrexed and cisplatin or carboplatin as first-line treatment for unresectable malignant pleural mesothelioma (STELLAR): a multicentre, single-arm phase 2 trial
Phase 2N = 80NCT02397928
- Population
- Treatment-naive adults (18 years or older) with histologically confirmed unresectable malignant pleural mesothelioma, ECOG performance status 0-1, and at least one measurable or evaluable lesion by modified RECIST for mesothelioma.
- Design
- Prospective, multicentre, single-arm phase 2 trial at 12 European sites. Continuous TTFields at 150 kHz to the thorax with intravenous pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 or carboplatin AUC 5 on day 1 every 21 days for up to six cycles; patients not progressing after chemotherapy continued TTFields as maintenance until progression, patient or physician decision, or unacceptable toxic effects. Survival analyses in the ITT population; safety in all patients who received at least one day of TTFields. The paper reports 80 patients enrolled between 9 February 2015 and 21 March 2017; ClinicalTrials.gov lists actual enrolment of 82, and the FDA summary describes 80 patients at 13 investigational sites.
- Primary endpoint
- OS
- Arms
- TTFields plus pemetrexed and platinum (experimental, n = 80): TTFields 150 kHz to the thorax with pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 or carboplatin AUC 5 every 21 days for up to six cycles, then TTFields maintenance until progression
- People
- Ceresoli GL
Show the numbers
| Endpoint | Analysis | TTFields plus pemetrexed and platinum | Control | Effect |
|---|---|---|---|---|
| OS | primarymedian follow-up 12.5 monthsCeresoli 2019 | median 18.2 months (12.1–25.8) | — | Single-arm study: there is no comparison group. Median follow-up 12.5 months (IQR 7.4-16.6). Skin reaction was the only adverse event the authors associate with TTFields: grade 1-2 in 53 (66%) patients and grade 3 in four (5%); no treatment-related deaths were observed. |
| PFS | primarySource 2019 | median 7.6 months (6.7–8.6) | — | Secondary endpoint, reported in the FDA Summary of Safety and Probable Benefit rather than in the abstract of the journal paper; the summary states that all analyses were in the ITT population and that its data were collected through March 2018. The same summary prints median OS 18.2 months (95% CI 12.1-25.8), identical to the paper. |
| Endpoint | Analysis | TTFields plus pemetrexed and platinum | Control | Effect |
|---|---|---|---|---|
| OS | primarymedian follow-up 12.5 monthsCeresoli 2019 | median 18.2 months (12.1–25.8) | — | Single-arm study: there is no comparison group. Median follow-up 12.5 months (IQR 7.4-16.6). Skin reaction was the only adverse event the authors associate with TTFields: grade 1-2 in 53 (66%) patients and grade 3 in four (5%); no treatment-related deaths were observed. |
| PFS | primarySource 2019 | median 7.6 months (6.7–8.6) | — | Secondary endpoint, reported in the FDA Summary of Safety and Probable Benefit rather than in the abstract of the journal paper; the summary states that all analyses were in the ITT population and that its data were collected through March 2018. The same summary prints median OS 18.2 months (95% CI 12.1-25.8), identical to the paper. |
- TTFields plus pemetrexed and platinum (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | TTFields plus pemetrexed and platinum |
|---|---|
| 0 | 100.0% |
| 11 | 65.8% |
| 23 | 41.6% |
| 34 | 27.4% |
| 46 | 17.3% |
- TTFields plus pemetrexed and platinum (experimental)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | TTFields plus pemetrexed and platinum |
|---|---|
| 0 | 100.0% |
| 5 | 63.4% |
| 10 | 40.2% |
| 14 | 27.9% |
| 19 | 17.7% |
Appears in
Sources
Ceresoli GL, Aerts JG, Dziadziuszko R, Ramlau R, Cedres S, van Meerbeeck JP, et al. Tumour Treating Fields in combination with pemetrexed and cisplatin or carboplatin as first-line treatment for unresectable malignant pleural mesothelioma (STELLAR): a multicentre, single-arm phase 2 trial. Lancet Oncol. 2019;20(12):1702-1709.
US Food and Drug Administration, Center for Devices and Radiological Health. Summary of Safety and Probable Benefit, HDE H180002, NovoTTF-100L System (Novocure); notice of approval to applicant 23 May 2019.