STELLAR-305: phase II/III study of zanzalintinib plus pembrolizumab versus pembrolizumab alone in patients with HNSCC
Bibliographic record
Abstract
Despite therapeutic advances in the treatment of recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), survival outcomes with immune checkpoint inhibitor (ICI) therapy, with or without chemotherapy, remain unsatisfactory, indicating a need for more effective treatments in this setting. The overexpression or hyperactivation of VEGF receptor, MET, and AXL in HNSCC can promote tumor growth, angiogenesis, metastasis, and an immune-suppressive tumor microenvironment. Through the potent, multitargeted inhibition of these tyrosine kinases, zanzalintinib (XL092) has been shown to reduce tumor cell proliferation and survival, suppress angiogenesis, and promote an immune-permissive tumor microenvironment. In vivo, zanzalintinib plus an ICI resulted in enhanced tumor growth inhibition when compared with either agent alone. STELLAR-305 is a randomized, double-blind, phase II/III study to evaluate the efficacy and safety of zanzalintinib plus pembrolizumab versus placebo plus pembrolizumab in adult patients with programmed cell death ligand 1-positive (combined positive score ≥ 1) R/M HNSCC that is not curable by local therapy, who have not received prior systemic therapy for R/M disease. The dual primary endpoints are progression-free survival (PFS) by blinded independent central review (BICR) and overall survival. Secondary endpoints include safety, investigator-assessed PFS, and objective response rate and duration of response per BICR and investigator review.Tweetable abstract STELLAR-305: design of an ongoing phase III #clinicaltrial, assessing the multi-targeted tyrosine kinase inhibitor, zanzalintinib, in combination with pembrolizumab in previously untreated recurrent/metastatic #HNSCC.Clinical trial registration NCT06082167 (ClinicalTrials.gov).
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How this classification was reachedexpand
Direct model labels (unvalidated)
Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.
| Model arm | Categories | Study design | Confidence |
|---|---|---|---|
| gemma | no category Domain: not available · Genre: Empirical About the Canadian research system: no · About a Canadian topic: no | Randomized trial | high |
| gpt | no category Domain: not available · Genre: Empirical About the Canadian research system: no · About a Canadian topic: no | Randomized trial | medium |
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 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| 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 | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 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, unvalidatedLabeled directly by 2 models reading the full record.
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".