Tests radiation before drug and chemotherapy for early lung cancer
Tests radiation followed by toripalimab and chemotherapy in adults with resectable lung cancer.
Key facts
- Who runs it
- Shanghai Chest Hospital
- Where
- Shanghai, ChinaSee the site
- Trial code
- Registry title
- Neoadjuvant Therapy of SBRT Sequencial With Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients(neoR-TORCH)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 478 people, planned
- Started
- 12 Sept 2024
- Expected to end
- Jun 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- SBRT
- Toripalimab
- Record updated
- 13 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with stage II-III non-small cell lung cancer that can be removed by surgery and who have not been treated yet. It compares radiation (SBRT) followed by toripalimab and chemotherapy with toripalimab and chemotherapy alone.
- Age
- 18 to 75 years
- Sex
- Men and women can join.
- Disease stage
- Non-small cell lung cancer, stage II, IIIA or IIIB (N2), that can be removed by surgery, with measurable lesions. Lung function must allow lung surgery.
- Earlier treatment
- No earlier treatment for this cancer. No earlier systemic anti-cancer therapy for early lung cancer, and no earlier PD-1/PD-L1 drugs or similar drugs.
- Biomarker or test result
- No sensitive EGFR or ALK gene changes. Tumor tissue must be available to test PD-L1 and other markers.
Main reasons for not taking part
- Cancer that cannot be removed by surgery or has spread to other organs
- Known sensitive EGFR change or ALK translocation
- Known HIV infection, active tuberculosis, or uncontrolled hepatitis B or active hepatitis C
- Known or suspected autoimmune disease or weak immune system, with some exceptions
- Another cancer within the last 5 years, with a few exceptions
The registry criteria, word for word
Show all 27 criteriaShow less
Who can take part
- Aged 18 -75 years, regardless of gender;
- ECOG score 0-1
- Treatment-naive, histologically confirmed resectable, stage II, IIIA, IIIB (N2) (AJCC staging system, version 8) NSCLC
- Measurable lesions based on the response evaluation criteria in solid tumors version 1.1
- Tumor tissue specimens available for pathological diagnosis, detection of PD-L1 expression and biomarkers prior to randomization
- According to the doctor's judgment, lung function can meet the requirements of pneumonectomy
- Confirming the absence of EGFR/ALK sensitive gene mutations through molecular pathological diagnosis of the organization
- Good organ function:; Bone marrow function: absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, hemoglobin ≥9 g/dL; Liver function: total bilirubin ≤ 1.5 × ULN, ALT and AST ≤ 1.5 × ULN; Renal function: serum creatinine ≤ 1.5 × ULN or serum creatinine clearance rate ≥ 60 mL/min; blood urea nitrogen ≤ 200mg/L
- Having sufficient understanding of this study and being willing to sign the informed consent form; 10. For female subjects of childbearing age, the serum pregnancy test should be negative within 3 days before receiving the first dose (cycle 1, day 1)
Who cannot take part
- Previous treatment with systemic antitumor therapy for early NSCLC, including investigational product
- Vaccination of live vaccine within 30 days prior to the first dose. Including but not limited to the following: parotitis, rubella, measles, varicella/ herpes zoster (varicella), yellow fever, Rabies, Bacille Calmette-Guérin (BCG) and typhoid vaccine (inactivated virus vaccine allowed)
- Previous use of PD-1/PD-L1 agent or the drug acting on another targeted T cell receptor (e.g., CTLA-4, OX-40)
- Other malignant tumors within 5 years prior to the first dose, except non-small cell lung cancer. The malignant tumors with negligible risk of metastasis or death (e.g., expected disease-free survival > 5 years) and expected to achieve radical outcomes after treatment (e.g., sufficiently treated carcinoma in situ of cervix, basal or squamous cell skin cancer, ductal carcinoma in situ treated for radical surgery) can be excluded
- Have locally advanced unresectable or metastatic disease; unresectable includes unresectable stage III non-small cell lung cancer as defined by the Multidisciplinary Diagnosis and Treatment Consensus (2019 edition), including partial stages IIIA and IIIB and all stage IIIC, N2: single station mediastinal lymph nodes with short diameter≥3cm or N2: multi-station mediastinal metastasis with lymph node fusion and the short diameter of lymph node ≥2cm on CT, T4 invading esophagus, heart, aorta, pulmonary veins and all the N3
- History of (non-infectious) pneumonitis/interstitial lung disease requiring steroid treatment, or ongoing pneumonitis/interstitial lung disease requiring steroid treatment
- Active tuberculosis;
- Active infection requiring systemic treatment;
- Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes
- Known human immunodeficiency virus (HIV) infection (known positive HIV antibody)
- Severe allergic reaction to other monoclonal antibodies
- History of serious allergy to Pemetrexed, paclitaxel or docetaxel, cisplatin, carboplatin or its preventive medications
- Known serious or uncontrolled pre-existing diseases; including but not limited to cardiovascular events with hemodynamic instability, symptomatic cerebrovascular events, and hepatic cirrhosis above Child-Pugh A within 6 months
- Participants with known EGFR sensitive mutations or ALK translocation, EGFR and ALK mutation status needs to be identified for the subjects with non-squamous cell carcinoma
- Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen [HBsAg] in screening period with HBV-DNA detected higher than the upper limit of normal at the clinical laboratory of the study center); (the subjects with HBV-DNA assay <500 IU/mL within 28 days prior to randomization who have received local standard antiviral therapy for at least 14 days and are willing to receive antiviral therapy continuously during the study can be enrolled); active hepatitis C (defined as positive hepatitis C surface antibody [HCsAb] in screening period and positive HCV-RNA)
- History or current evidence of any disease, therapy or abnormal laboratory examination that may confuse the study results, interfere with subject's participation in the full course of the study or not meet the best interest of subject's participation in the study, as judged by investigators
- NSCLC involving superior sulcus, large cell neuroendocrine carcinoma (LCNEC), sarcomatoid tumor
- ≥ grade 2 peripheral neuropathy;
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in China
- Shanghai Chest HospitalShanghai, ChinaContact: Xuwei CaiTaking people
About the trial
What the trial wants to find out
This is a randomized, controlled, multi-center, phase III clinical study to evaluate the efficacy and safety of SBRT sequencial with Toripalimab and chemotherapy versus Toripalimab and chemotherapy for subjects with resectable, stage II-III NSCLC.
The 2 groups in the trial
- ExperimentalTreatment being tested
Participants receive SBRT for primary lung tumor, sequential receive totally 4 cycles of Toripalimab combined with platinum doublet chemotherapy during perioperative period ; participants receive consolidation therapy of Toripalimab Intervention: SBRT: 24Gy/3fractions; Drug: 4cycles(Toripalimab IV 240mg + platinum-based doublet chemotherapy)+13 cycles(Toripalimab IV 240mg); Biological: Toripalimab
Treatment: SBRT and Toripalimab
- Active ComparatorExisting treatment, for comparison
Participantsreceive totally 4 cycles of Toripalimab combined with platinum doublet chemotherapy during perioperative period ; participants receive consolidation therapy of Toripalimab Intervention: Drug: 4cycles(Toripalimab IV 240mg + platinum-based doublet chemotherapy)+13 cycles(Toripalimab IV 240mg); Biological: Toripalimab
Treatment: Toripalimab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Neoadjuvant Therapy of SBRT Sequencial With Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC Patients: A Multicenter, Openlabel, Randomized, Phase III Trial
- Plain-language title
- Tests radiation before drug and chemotherapy for early lung cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06437977, who can take part
- Record updated
- 13 May 2026