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).
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 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 | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| 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, 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".