Non small cell lung cancer
Conditions
Interventions
1:Toripalimab +SABR
Sponsors
Jinling Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically proven non-small-cell lung cancer (core biopsy required); 2. Squamous or non-squamous histology; 3. Diagnostic core biopsy specimens must be reviewed by a faculty pathologist at Jinling hospital; 4. Either a formalin fixed paraffin block or a minimum of fifteen 5-micron tissue sections (slides) of tumor biopsy sample must be available for biomarker evaluation (study pathologist must review for adequacy of sampling). This can be obtained from archived tissues, or from a new biopsy if needed; 5. Stage IIIA NSCLC with resection option for potential cure, as assessed by a faculty surgeon at Jinling hospital. This may include clinical stage IIIA (T1N2M0T2N2M0)(AJCC v8); 6. ECOG performance status 0-1. Adequate organ function as follows: Leukocytes >=2,000/mm3; Absolute neutrophil count (ANC) >=1000/mm3; Platelet count >=100,000/mm3; Hemoglobin >=9 g/dL; Creatinine =40 mL/min (if using the Cockcroft-Gault formula below): Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL; Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL Total Bilirubin <=1.5 ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL); AST(SGOT), ALT(SGPT), and alkaline phosphatase <=3 times the upper limit of normal; Subjects must have adequate lung function to permit surgical resection determined by pre-enrollment pulmonary function tests to include DLCO; The effects of nivolumab on the developing human fetus are unknown. For this reason, 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 nivolumab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Sexually active fertile men must use effective barrier birth control if their partners are WOCBP for up to 31 weeks after the last dose of nivolumab. 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; Patient understands the study regimen, its requirements, risks and discomforts and is able and willing to sign the informed consent form. Voluntary signed and dated approved written informed consent form in accordance with regulatory and institutional guidelines must be obtained before the performance of any protocol related procedures that are not part of normal patient care. Subjects must be competent to report AEs, understand the drug dosing schedule and use of medications to control AEs.
Exclusion criteria
Exclusion criteria: 1. Mixed with small cell lung cancer; 2. EGFR ALK ROS1+; 3. Subjects are excluded if they have an active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger; 4. Subjects are excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration;Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Administration of chemotherapy or any other cancer therapy in the pre-operative period; 5. 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); 6. Subjects with a history of symptomatic interstitial lung disease; 7. Active systemic infection requiring therapy, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA); 8. Known positive history or positive test for Human Immunodeficiency Virus or Acquired ImmunoDeficiency Syndrome (AIDS); 9. History of allergy to study drug components; 10. Women who are pregnant or nursing; 11. Men with female partners (WOCBP) that are not willing to use contraception; 12. 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); 13. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events; 14. 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 |
|---|---|
| Safety;Pathologic Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiographic Response;Recurrence-free survival; | — |
Countries
China
Contacts
Public ContactYong Song
Jinling Hospital
Outcome results
None listed