Toripalimab Combined With Platinum-based Chemotherapy With or Without H1 Receptor Antagonist in t… (NCT07358689) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Toripalimab Combined With Platinum-based Chemotherapy With or Without H1 Receptor Antagonist in the Perioperative Treatment of Resectable Non-small Cell Lung Cancer
China120 participantsStarted 2026-06-30
Plain-language summary
The goal of this clinical trial is to evaluate the efficacy and safety of H1 receptor antagonist (diphenhydramine) combined with toripalimab plus standard platinum-based chemotherapy in the perioperative setting in subjects with operable NSCLC.
The subjects of this study are patients with histologically or cytologically confirmed stage II-III NSCLC (AJCC Version 9) who are planned to receive neoadjuvant therapy with toripalimab combined with standard platinum-based chemotherapy. Eligible subjects were randomized at a 1:1 ratio to receive 3-4 cycles of neoadjuvant diphenhydramine (an H1 receptor antagonist) plus toripalimab and standard platinum-based chemotherapy, or toripalimab plus platinum-based chemotherapy alone, followed by treatment response evaluation and definitive surgery. After surgery, the experimental group will receive maintenance therapy with diphenhydramine (an H1 receptor antagonist) plus toripalimab for 13-14 cycles, while the control group will receive toripalimab monotherapy for the same 13-14 cycles.
Who can participate
Age range
18 Years – 75 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
. Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹/L without administration of granulocyte colony-stimulating factor within the past 14 days;
. Platelet count ≥ 80 × 10⁹/L without blood transfusion within the past 14 days;
. Hemoglobin \> 8 g/dL without blood transfusion or erythropoietin administration within the past 14 days;
. Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN);
. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 × ULN (for subjects with liver metastasis, AST or ALT ≤ 5 × ULN is acceptable);
. Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated by the Cockcroft-Gault formula) ≥ 60 mL/min;
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.
1This trial is testing toripalimab combined with platinum-based chemotherapy for resectable non-small cell lung cancer, and I've mostly heard about pembrolizumab or nivolumab in this setting — can you explain how toripalimab compares to those immunotherapies and why this combination might or might not make sense for my situation?
2Since this is a Phase 2 trial, the main goal seems to be seeing how many patients achieve a pathological complete response — meaning no detectable cancer at surgery — so what do we actually know so far about how safe and effective this regimen is, and what would the gaps in evidence mean for my treatment decision?
3The trial includes an H1 receptor antagonist as one of the variables being tested, which is unusual — can you help me understand why an antihistamine-type drug is being added, and what that might mean in terms of potential benefits or side effects I should be aware of?
4The trial isn't recruiting yet, so realistically how long might it be before I could even enroll, and given that my cancer is described as resectable right now, is it safe to wait, or would standard perioperative treatment be a better path to consider first?
5What are the standard-of-care options already approved for resectable non-small cell lung cancer in the perioperative setting, and how would participating in this trial compare to those established options in terms of what we know about outcomes?
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
Pathological complete response (pCR) rate
Timeframe: Up to 1 year
Trial details
NCT IDNCT07358689
SponsorTianjin Medical University Cancer Institute and Hospital
. Adequate coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN;
. Normal thyroid function, defined as Thyroid Stimulating Hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total triiodothyronine (T3) (or free triiodothyronine \[FT3\]) and free thyroxine (FT4) within the normal range are also eligible for enrollment;