non-small cell lung cancer
Conditions
Interventions
treatment group:Patients received neoadjuvant treatment with intravenous PD-1 inhibitor (200mg) on day 1 with platinum-containing dual-agent chemotherapy on day 1 (and day8) of each 21-day cycle. Two
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Men and women aged at least 18 years; 2. Histologically or cytologically proven non-small-cell lung cancer; (1) Squamous or non-squamous histology (2) Pathological diagnosis must be reviewed by one faculty pathologist; (3) A formalin fixed paraffin blocked tissue sections (slides) of tumor sample could be used for biomarker evaluation (pathologist must review for adequacy of sampling). This can be obtained from archived tissues, or from a new biopsy if possible. (For details of handling of new tissue biopsies, please refer to the lab manual); 3. Stage - Patients with NSCLC have the potential to cure after resection, as assessed by a faculty surgeon. This includes clinical stage I (primary tumor must measure >= 3cm in diameter on CT imaging), II and IIIA; 4. ECOG performance status 0-1; 5. Adequate organ function as follows: (1) Leukocytes >= 2,000/mm3; (2) Absolute neutrophil count (ANC)>= 1000/mm3; (3) Platelet count >= 100,000/mm3; (4) Hemoglobin >= 9 g/dL; (5) Creatinine <= 2.0 mg/dL; (6) Bilirubin (total) within normal institutional limits (except subjects with Gilbert Syndrome who must have total bilirubin < 3.0 mg/dL); (7) AST(SGOT), ALT(SGPT), and alkaline phosphatase <= 2.5 times the upper limit of normal; (8) Subjects must have adequate lung function to permit surgical resection determined by baseline pulmonary function tests. Baseline SPO2 must be no less than 92% both at rest and while walking, off supplemental oxygen; 6. The effects of sintilimab on the developing human fetus are unknown. Therefore, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for up to 23 weeks after the last dose of sintilimab. If a woman become pregnant or suspect pregnant while she or her partner is participating in this study, her treating physician should be informed immediately. Sexually active fertile men must use effective barrier birth control if their partners are WOCBP before 31 weeks after the last dose of sintilimab. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within two weeks of registration. Women must not be breastfeeding; 7. Patients should sign the informed consent form after understanding the study regimen, requirements, risks and discomforts. Voluntary signed and dated written informed consent form approved by IRB/IEC in accordance with regulatory and institutional guidelines must be obtained before the performance of any protocol related procedures which differs from normal treatment or care. Subjects should have the ability to understand how to use medicines to treat AEs.
Exclusion criteria
Exclusion criteria: 1. Has active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. Has a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose. Inhaled or topical steroids and adrenal replacement steroid doses are permitted in the absence of active autoimmune disease; 2. Administration of chemotherapy or any other cancer therapy in the pre-operative period; 3. Subjects with active concurrent malignancies are excluded i.e. cancers other than NSCLC (except non melanoma skin cancers, in situ bladder, gastric, breast, colon or cervical cancers/dysplasia; 4. Subjects with brain metastasis are excluded from this study and all patients should have brain imaging (either MRI brain or CT brain with contrast) prior to enrollment; 5. Subjects with a history of interstitial lung disease; 6. Active systemic infection requiring therapy, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA); 7. Known positive history or positive test for Human Immunodeficiency Virus or Acquired Immunodeficiency Syndrome (AIDS); 8. History of allergy to study drug components; 9. Women who are pregnant or nursing; 10. Men with female partners (WOCBP) that are not willing to use contraception; 11. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T cell co-regulatory pathways); 12. Underlying medical conditions that, in the Investigators opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events; 13. Prisoners or subjects who are involuntarily incarcerated or compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AEs;Major pathological response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival;overall survival;R0 resection rate; | — |
Countries
China
Contacts
Public ContactZhang peng
Shanghai Pulmonary Hospital
Outcome results
None listed