Stage ?-? EGFR/ALK Wild-Type NSCLC
Conditions
Interventions
Toripalimab + Single-Agent Chemotherapy Arm:Patients first received 2 cycles of neoadjuvant therapy as follows: Toripalimab 240 mg IV Q3W
Single-agent chemotherapy (Paclitaxel or Pemetrexed).
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years; 2. ECOG PS score 0-1; 3. Treatment-naïve patients with histologically/cytologically confirmed NSCLC (via biopsy) and radiologically confirmed Stage II-III disease; 4. Patients with adenocarcinoma need to confirm the absence of EGFR, ALK, and other driver gene mutations; Patients with squamous cell carcinoma do not need to undergo genetic testing; 5. The patient must have a measurable lesion; 6. Patients with disease assessment of CR, PR or SD after 2 cycles of atezolizumab combined with non-platinum single-agent chemotherapy as neoadjuvant chemotherapy; 7. Life expectancy is at least 12 weeks; 8. Other major organs (liver, kidney, blood system, etc.) function well: – Hemoglobin >=9.0 g / dL (can be maintained by transfusion or above this level); – Red blood cell count >= 2.0 × 10^9/L – Neutrophil absolute count (ANC) >=1.0 × 10^9/L; – Platelet count >= 100 × 10^9/L; – Total bilirubin is within normal limits; – Alanine transaminase, aspartate transaminase, alkaline phosphatase =60 ml/min; – Patients who have not received anticoagulant therapy have a prothrombin time international normalized ratio (INR) <=1.5 and a partial thromboplastin time (APTT) <=1. 5 times the upper limit of normal. Patients receiving full or parenteral anticoagulant therapy can enter clinical trials as long as the dose of anticoagulant drugs is stable for at least 2 weeks before entering clinical trials, and the results of coagulation tests are within the limits of local treatment. 9. No systemic metastasis; 10. Expected to be completely resected; 11. Lung function is good and can tolerate surgical treatment; 12. Women of childbearing age must undergo a pregnancy test within 7 days before starting treatment and the result must be negative; and the start and end of the test; 13. The subject should use reliable contraceptives (such as intrauterine devices, contraceptives and condoms) during the trial and within 30 days after the end of the trial; 14. Subjects voluntarily join the study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Prior systemic anti-cancer therapy for NSCLC (beyond protocol-specified neoadjuvant treatment), including: surgery, local radiotherapy, cytotoxic/targeted drugs, or investigational agents; 2. Patients with other cancers other than NSCLC within five years prior to the start of this trial; 3. There are unstable systemic diseases, such as uncontrolled hypertension and severe arrhythmia; 4. Active, known or suspected autoimmune disease; 5. Allergic to the test drug; 6. Have had or currently have interstitial lung disease; 7. Co-infection with HIV; 8. Patients who have undergone other major surgery or severe trauma within 2 months before the start of this trial; 9. Pregnant or breastfeeding women; 10. Patients with neurological or psychiatric diseases who cannot cooperate; 11. Other researchers believe that it is not suitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological Complete Response, pCR ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival, OS;Major Pathologic Response Rate;Event-free Survival, EFS;Safety; | — |
Countries
China
Contacts
Public ContactZhenfa Zhang
Tianjin Medical University Cancer Institute and Hospital
Outcome results
None listed