STELLAR
STELLAR is the small single-arm study behind the device approval of tumour treating fields in mesothelioma.
Median OS 18.2 months versus 12.1 months in a historical chemotherapy control; led to FDA Humanitarian Device Exemption approval (May 2019). No randomised confirmation.
Setting
Unresectable pleural mesothelioma, first line: TTFields (150 kHz) + platinum-pemetrexed, single arm
Phase
Phase 2
Sponsor
Novocure
Registry
Headline result
Median OS 18.2 months (single arm) vs 12.1 historical.
Reported
2019
Enrolled
80
Replication
Not replicated in a randomised trial; HDE approval is for a rare disease with limited evidence requirements.
In plain words
What these results mean for people, not percentages
Overall survival (single arm vs historical)survival endpoint
- Median 18.2 vs 12.1 months with TTFields + chemotherapy compared with Historical chemotherapy control; about 6.1 months longer for half the group.
- A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
- These results apply to the people the trial enrolled: Unresectable pleural mesothelioma, first line: TTFields (150 kHz) + platinum-pemetrexed, single arm. People in a different situation may not see the same effect.
- Only 80 people took part, so the numbers are less certain than in a large trial.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
80 participants enrolled.
Overall survival (single arm vs historical)
TTFields + chemotherapy
18.2 mo
Historical chemotherapy control
12.1 mo
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (single arm vs historical) | TTFields + chemotherapy | 80 | 18.2 months | — | — | — |
| Historical chemotherapy control | — | 12.1 months |
Replication
Not replicated in a randomised trial; HDE approval is for a rare disease with limited evidence requirements.