ADRIATIC: Durvalumab (D) as consolidation treatment (tx) for patients (pts) with limited-stage small-cell lung cancer (LS-SCLC).
Why this work is in the frame
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Bibliographic record
Abstract
LBA5 Background: The standard of care (SoC) for pts with LS-SCLC is concurrent platinum-based chemoradiotherapy (cCRT) ± prophylactic cranial irradiation (PCI). ADRIATIC (NCT03703297), a phase 3, randomized, double-blind, placebo (PBO)-controlled, multicenter, global study, assessed D ± tremelimumab (T) as consolidation tx for pts with LS-SCLC who had not progressed after cCRT. Here we report results for D vs PBO from the first planned interim analysis (IA). Methods: Eligible pts had stage I–III LS-SCLC (stage I/II inoperable) and WHO performance status 0/1, and had not progressed after cCRT. PCI was permitted before randomization. Pts were randomized 1–42 days after cCRT to D 1500 mg + PBO, D 1500 mg + T 75 mg, or PBO + PBO every 4 weeks (Q4W) for 4 cycles, followed by D (D±T arms) or PBO Q4W until investigator-determined progression or intolerable toxicity, or for a maximum of 24 months (mo). The first 600 pts were randomized in a 1:1:1 ratio; subsequent pts were randomly assigned 1:1 to D or PBO. Randomization was stratified by stage (I/II vs III) and receipt of PCI (yes vs no). The dual primary endpoints were OS and PFS (blinded independent central review per RECIST v1.1) for D vs PBO. OS and PFS for D+T vs PBO were alpha-controlled secondary endpoints. Results: 730 pts were randomized, including 264 to D and 266 to PBO. Baseline characteristics and prior tx were well balanced between arms. Radiation schedule in the D vs PBO arms was once daily in 73.9% vs 70.3% of pts and twice daily in 26.1% vs 29.7%; 53.8% of pts in each arm received PCI. At this IA (data cutoff 15Jan2024), median (range) duration of follow-up for OS and PFS in censored pts was 37.2 (0.1–60.9) and 27.6 (0.0–55.8) mo, respectively. OS was significantly improved with D vs PBO (HR 0.73 [95% CI 0.57–0.93]; p=0.0104; median OS 55.9 [95% CI 37.3 – not estimable] vs 33.4 [25.5–39.9] mo; 24-mo OS rate 68.0% vs 58.5%; 36-mo OS rate 56.5% vs 47.6%). PFS was also significantly improved with D vs PBO (HR 0.76 [95% CI 0.61–0.95]; p=0.0161; median PFS 16.6 [95% CI 10.2–28.2] vs 9.2 [7.4–12.9] mo; 18-mo PFS rate 48.8% vs 36.1%; 24-mo PFS rate 46.2% vs 34.2%). Tx benefit was generally consistent across predefined pt subgroups for both OS and PFS. With D vs PBO, maximum grade 3/4 all-cause adverse events (AEs) occurred in 24.3% vs 24.2% of pts; AEs led to tx discontinuation in 16.3% vs 10.6% of pts and to death in 2.7% vs 1.9%. Any-grade pneumonitis/radiation pneumonitis was reported in 38.0% vs 30.2% of pts with D vs PBO (maximum grade 3/4 in 3.0% vs 2.6%). The D+T arm remains blinded until the next planned analysis. Conclusions: D as consolidation tx after cCRT demonstrated a statistically significant and clinically meaningful improvement in OS and PFS compared with PBO in pts with LS-SCLC. D was well tolerated and AEs were consistent with the known safety profile, with no new signals observed. These data support consolidation D as a new SoC for pts with LS-SCLC who have not progressed after cCRT. Clinical trial information: NCT03703297 .
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it