LBA2 First-line (1L) durvalumab (D) + platinum-etoposide (EP) for patients (pts) with extensive-stage SCLC (ES-SCLC): Primary results from the phase IIIb LUMINANCE study
Bibliographic record
Abstract
The phase 3 CASPIAN study (NCT03043872) of 1L D + EP (4 cycles) vs EP alone (up to 6 cycles) in pts with ES-SCLC (WHO performance status [PS] 0–1) established D + EP as a global standard of care. However, like most phase 3 registration studies, elements of the study design did not fully reflect real-world clinical practice. The phase 3b LUMINANCE study (NCT04774380) evaluated D + up to 6 cycles of EP in pts with ES-SCLC, including those with WHO PS 2. We report results of the primary analysis. Pts with treatment (tx)-naïve ES-SCLC and WHO PS 0–2 received D 1500 mg + EP Q3W for up to 6 cycles (investigator decision), followed by D Q4W until progression. Primary endpoints were rates of grade ≥3 AEs and immune-mediated AEs (imAEs); secondary endpoints included objective response rate (ORR), duration of response (DoR), PFS and OS. As of 12 June 2023, 152 pts from 32 sites/5 countries had received tx, median follow-up was 37.3 weeks and 23.7% were still receiving D. Median age was 64.0 years, 64.5% of pts were male and 99.3% were white. Median no. of D doses was 8.5 (Table); 63.8% of pts received carboplatin and 38.8% received cisplatin. Grade ≥3 AEs occurred in 59.2% of pts (Table); most common were neutropenia (26.3%), anaemia (9.9%) and neutrophil count decreased (7.9%). Grade ≥3 AEs occurred in 44/66 (66.7%) and 45/85 (52.9%) pts who received 1–4 or ≥5 cycles of EP*, respectively. imAEs occurred in 13.8% of pts; most common was hypothyroidism (6.6%). Confirmed ORR (95% CI) was 65.8% (57.7–73.3); median PFS (95% CI) was 6.2 (5.3–6.5) months (mo); and median OS (95% CI) was 13.1 (10.1–not estimable [NE]) mo. Numerically better outcomes were observed in pts who received ≥5 cycles of EP (Table).Table: LBA2Total (N=152)Median (range) D doses8.5 (1–19)EP cycles* Median (range) ≥4, n (%) ≥5, n (%) 6, n (%)– 5.0 (1–6) 133 (87.5) 85 (55.9) 74 (48.7)Any-cause AE, n (%) Grade ≥3 Serious Led to tx discontinuation Led to death† imAE142 (93.4) 90 (59.2) 49 (32.2) 22 (14.5) 15 (9.9) 21 (13.8)Total (N=152)1–4 cycles of EP‡ (n=68)≥5 cycles of EP‡ (n=84)Confirmed ORR, n (%) 95% CI100 (65.8) 57.7–73.332 (47.1) 34.8–59.668 (81.0) 70.9–88.7Median DoR, mo 95% CI5.1 4.9–5.34.8 3.3–5.25.2 5.0–6.3Median PFS, mo 95% CI6.2 5.3–6.54.6 3.7–4.66.5 6.3–7.6Median OS, mo 95% CI13.1 10.1–NE10.7 6.4–16.8NR 11.0–NE*Based on etoposide; 1 pt received no etoposide. †4 possibly related to EP; none to D. ‡Based on platinum. NR, not reached Open table in a new tab *Based on etoposide; 1 pt received no etoposide. †4 possibly related to EP; none to D. ‡Based on platinum. NR, not reached Safety and efficacy findings from LUMINANCE, including those pts who received ≥5 cycles of induction chemo-IO, were consistent with those observed in CASPIAN. The results further support the use of D + EP as 1L tx for pts with ES-SCLC.
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How this classification was reachedexpand
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 | 0.004 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.002 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 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 itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".