Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma (NCT06418724) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant PD-1 Inhibitor and EGFR Inhibitor in Locally Advanced Cutaneous Squamous Cell Carcinoma
27 participantsStarted 2026-07-30
Plain-language summary
The NEOPECS trial is a phase II prospective, single-arm, non-randomised interventional trial for patients with borderline resectable locally advanced cutaneous squamous cell carcinoma with a 6-participant safety lead in to ensure safety of the combination in the neoadjuvant setting across 3 sites in Australia.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female \> 18 years of age and able to comply with treatment, assessment and follow up
. Documentation of a locally advanced cutaneous squamous cell carcinoma diagnosis as evidenced by histopathology with available archival tissue. Locally Advanced cutaneous Squamous Cell Carcinoma (LASCC) defined as borderline resectable for surgery due to multiple recurrences, prior radiotherapy, large extension, bone erosion and/or deep infiltration beyond the subcutaneous tissue into muscle/nerve or, where curative resection may lead to unacceptable complications, morbidity or deformity, and ineligible for curative radiotherapy
. Measurable disease in accordance with iRECIST criteria OR clinically measurable disease \>1cm by caliper measurement. Patients with synchronous primary cutaneous squamous cell carcinoma (cSCC) tumours will be eligible.
. Adequate bone marrow function with haemoglobin \>100g/L, absolute neutrophil count \> 1.5 x 109/L, platelets \> 100 x 109/L). Blood transfusion is allowable.
. Adequate hepatic function with total bilirubin levels \<1.5 upper limit normal range and Alanine aminotransferase (ALT) and AST levels \<2.5 level normal range.
. Adequate renal function with eGFR estimated with Cockcroft Gault formula \>50mL/min. Serum potassium levels 3.5 - 5.5 mmoL/L, Serum magnesium levels 0.7 - 1.05 mmol/L, Serum corrected calcium levels 2.15 - 2.55 mmol/L
. Adequate performance status of Eastern Cooperative Oncology Group (ECOG) 0-1 as assessed by investigator
. Life expectancy of \>6 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Preliminary activity
Timeframe: 3 months
Trial details
NCT IDNCT06418724
SponsorMelanoma and Skin Cancer Trials Limited
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-07-30
Contact for this trial
Melanoma and Skin Cancer Trials Ltd Project Officer
. Distant metastatic disease (M1) including visceral or distant nodal metastases
. Prior receipt of checkpoint inhibitor therapy or anti-EGFR therapy for LASCC or any other malignancy
. Uncontrolled medical/psychiatric co-morbidity as per investigator that may jeopardize the ability of the patient to undergo trial procedures with reasonable safety
. Uncontrolled autoimmune disease requiring active immune-suppression within 1 year of enrolment
. Corticosteroid use of \>10mg daily of oral prednisone within 2 weeks of Cycle 1 Day 1 (C1D1)
. Known history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases.
. Uncontrolled infection with human immunodeficiency virus, hepatitis B, or hepatitis C infection; or has a diagnosis of immunodeficiency