OncoMatch/Clinical Trials/NCT05283226
Study to Evaluate the Safety and Efficacy of Oral NRC-2694-A in Combination With Paclitaxel in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma, Who Progressed on or After Immune Checkpoint Inhibitor Therapy
Is NCT05283226 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including NRC-2694-A and Paclitaxel for carcinoma.
Treatment: NRC-2694-A · Paclitaxel — This is a Phase 2, open-label, multicenter, single-arm study of NRC-2694-A in combination with paclitaxel in patients with R/M HNSCC with progression on or after ICI therapy. A total of approximately 46 male and female patients will be enrolled. This sample size is based on Simon's 2-stage design with historical control ORR of 30% and a target ORR of 50%.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage IV
Metastatic disease required
Has histologically confirmed unresectable R/M HNSCC (oral cavity, oropharynx, hypopharynx, and larynx)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: immune checkpoint inhibitor (pembrolizumab, nivolumab) — recurrent and/or metastatic
Must have progressed during or after receiving ICI therapy, such as pembrolizumab or nivolumab
Cannot have received: cetuximab (cetuximab)
Exception: cetuximab used concomitantly with radiotherapy or as an induction therapy is acceptable
Has had prior cetuximab therapy for recurrent or metastatic disease. Note that cetuximab used concomitantly with radiotherapy or as an induction therapy is acceptable
Cannot have received: EGFR-targeted therapy
Has received any other EGFR-targeted therapies for recurrent or metastatic disease
Cannot have received: taxane (paclitaxel, docetaxel)
Exception: prior paclitaxel or docetaxel or any other drugs with taxane like mode of action as a component of a curatively-intended multimodality treatment for locally advanced HNSCC is permitted
Has received prior treatment with paclitaxel or docetaxel or any other drugs with taxane like mode of action for recurrent or metastatic or recurrent HNSCC. However, prior paclitaxel or docetaxel or any other drugs with taxane like mode of action as a component of a curatively-intended multimodality treatment for locally advanced HNSCC is permitted.
Lab requirements
Blood counts
neutrophil count ≥1500/mm3, platelet count ≥100,000/mm3, and hemoglobin level 8.0 g/dL
Kidney function
creatinine clearance ≥30 mL/min calculated by Cockcroft-Gault formula
Liver function
total bilirubin level ≤1.5 × ULN [except patients with documented Gilbert's syndrome] and serum transaminase levels ≤2.5 × ULN or ≤5 × ULN for liver metastasis and/or obstructive jaundice
adequate bone marrow reserve (neutrophil count ≥1500/mm3, platelet count ≥100,000/mm3, and hemoglobin level 8.0 g/dL), renal function (creatinine clearance ≥30 mL/min calculated by Cockcroft-Gault formula), liver function (total bilirubin level ≤1.5 × ULN [except patients with documented Gilbert's syndrome] and serum transaminase levels ≤2.5 × ULN or ≤5 × ULN for liver metastasis and/or obstructive jaundice)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Providence Medical Foundation -Fullerton · Fullerton, California
- Los Angeles Hematology Oncology Medical Group · Los Angeles, California
- Lynn Cancer Center · Boca Raton, Florida
- Miami Cancer Center · Miami, Florida
- Norton Cancer Institute - Downtown · Louisville, Kentucky
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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