Safety and efficacy of lanreotide depot/autogel (LAN) in patients with lung NETs: The randomized, double-blind, placebo (PBO)-controlled phase III SPINET study.
Bibliographic record
Abstract
TPS8580 Background: In the CLARINET study (NCT00353496), LAN was associated with significantly prolonged progression-free survival (PFS) in patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) of grade 1 or 2 (Ki-67 < 10%). Limited options are available for the treatment of patients with advanced lung NETs. The aim of the SPINET study is to evaluate the safety and antitumor efficacy of LAN 120 mg vs. PBO in these patients. Methods: SPINET is an international, multicenter, randomized, double-blind, PBO-controlled phase III study. Main inclusion criteria: adult patients with well-differentiated typical or atypical, metastatic and/or unresectable lung NETs, positive somatostatin-receptor imaging ( ≥ grade 2 Krenning scale), ≤ 1 course of chemotherapy, ECOG PS 0-1. A total of 216 patients will be enrolled from 80 sites across the USA, Canada, and Europe. Patients will be randomized 2:1 to receive either LAN (120 mg every 28 days) + best supportive care (BSC) or PBO + BSC, until progressive disease (PD)/death or unacceptable toxicity. Patients receiving PBO who experience PD may opt to receive LAN 120 mg in an open-label extension phase. All patients who experience PD will be followed to document survival, quality of life (QoL), and subsequent anticancer treatments. The primary endpoint, PFS (time from randomization to progressive disease [PD]/death), will be assessed based on central review using RECIST v1.1. Main secondary endpoints include PFS according to local review, objective response rates, overall survival, changes in plasma chromogranin (CgA) levels, LAN pharmacokinetics, QoL, and safety. This trial is active and registered with the EU Clinical Trials Register (EudraCT:2015-004992-62). Clinical trial information: 2015-004992-62.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 0.001 |
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 source (direct Gemma or distilled Codex), 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".