Efficacy and Safety of CRT, Durvalumab and Surgery for SST
Efficacy and Safety of CRT, Durvalumab and Surgery for SST
The safety and efficacy of multimodality treatment of pre- and post-operative durvalumab
 therapy after pre-operative chemoradiotherapy for resectable superior sulcus tumor (SST) and
 durvalumab maintenance therapy after chemoradiotherapy for unresectable SST
To evaluate the safety and efficacy of multimodality treatment of pre- and post-operative
 durvalumab therapy after pre-operative chemoradiotherapy for resectable superior sulcus tumor
 (SST) and durvalumab maintenance therapy after chemoradiotherapy for unresectable SST
Inclusion Criteria:

 1. A definite diagnosis of non-small cell lung cancer has been obtained by biopsy from
 the primary lesion.

 2. Meet all of the following (UICC-TNM classification 8th edition). I. Regarding the
 primary lesion, meet one of the following on chest CT. i. Direct invasion of the chest
 wall at or above the height of the first rib (at least invasion of the parietal
 pleura) ii. Direct invasion of the subclavian artery or vein II. Regarding regional
 lymph nodes, meet either of the following by chest CT and FDG-PET/CT. Metastasis is
 also considered if lymph node metastasis is determined by either chest CT or
 FDG-PET/CT.

 i. cN0 ii. cN1 and no metastases to #10, #11, and #12 lymph nodes iii. cN3
 (ipsilateral supraclavicular lymph node metastasis) and no metastases in regional
 lymph nodes (N1 and N2) other than "#13, #14 lymph nodes" III. No distant metastases
 (including intrapulmonary metastases in the same ling lobe and in a different lung
 lobe on the same side) on imaging tests including FDG-PET/CT

 3. It is judged that radical resection is possible by lobectomy (including bilobectomy
 for 2 lobes), which satisfies the following [1] and [2].

 I. The board respiratory surgeon judges that none of the following is true based on
 the image findings.

 i. There is vertebral body infiltration that requires total spondylectomy ii. Presence
 of spinal cord infiltration iii. Invaded trachea or tracheal bifurcation iv. Invasion
 of aortic arch or ascending aorta v. Invading brachial plexus at C8 or higher vi.
 Esophageal infiltration that requires esophageal reconstruction for resection vii.
 Pneumonectomy is required for radical resection II. Meet all of the following. i.
 Predicted postoperative forced expiratory volume of 1 second (FEV1.0) ≥ 800 mL within
 56 days before registration ii. SpO2 > 93% (room air) with the latest inspection value
 within 14 days before registration

 4. Consult with the radiotherapy doctor and it is judged that all of the following are
 met.

 I. Radiation therapy is possible according to the protocol II. The irradiation field
 does not reach the hilum

 5. The age of the registration date is 20 years or older and 75 years or yonger.

 6. Performance status (PS) is 0 or 1 according to ECOG standards (PS must be described in
 medical records)

 7. The presence or absence of measurable lesions is not required.

 8. No history of following surgery irrespective of whether for a benign or malignant
 lesion.

 I. Thoracoscopic surgery or thoracotomy with excision of the affected lung or
 esophagus or mediastinum (however, a history of thoracoscopic surgery without wedge
 resection or lung, esophagus, or mediastinal resection (eg, pleural biopsy)) is
 allowed) II. Median sternotomy surgery (with or without organ resection) III.
 Pulmonary resection other than wedge resection of the contralateral lung (whether
 open-heart surgery or thoracoscopic surgery)

 9. There is no history of chemotherapy, including treatment for other cancer types
 (including molecular targeted therapies and immune checkpoint inhibitors). However,
 the history of drug therapy as adjuvant therapy is allowed if it was completed more
 than 3 years ago. In addition, a history of hormone therapy for other cancer types is
 allowed.

 10. If there is a history of radiotherapy including other cancer types, the lung, hilum,
 mediastinum, and supraclavicular fossa are not included in the irradiation field.

 11. Chest CT does not show interstitial pneumonia or pulmonary fibrosis.

 12. No history of complication of autoimmune disease or chronic or recurrent autoimmune
 disease. However, patients with type 1 diabetes which is well controlled by
 appropriate treatment, hyperthyroidism/hypothyroidism that requires only antithyroid
 drug/hormone replacement therapy, autoimmune skin disease that does not require
 systemic treatment (Pemphigus, psoriasis vulgaris, pemphigus vulgaris, vitiligo), and
 celiac disease controlled only by dietary control are regarded as eligible if they
 have been inactive in the past 5 years, even with a history of autoimmune
 complications or history.

 13. No surgical treatment with general anesthesia within 14 days (2 weeks) before
 registration.

 14. No systemic administration of steroids, other immunosuppressive drugs, or
 immunoglobulins within 28 days (4 weeks) before registration. However, those that meet
 the following conditions are allowed.

 I. Intranasal/inhalation/topical steroid injection or local steroid injection (for
 example, intra-articular injection) II. Systemic administration of steroid drugs at a
 dose of 10 mg/day or less in terms of prednisolone III. Steroids as premedication (eg
 CT premedication)

 15. Can be taken orally.

 16. No ischemic changes were observed on the latest 12-lead ECG within 28 days before
 registration. However, if a 12-lead electrocardiogram shows ischemic changes,
 echocardiography, exercise electrocardiography, etc. should be performed, and if it is
 judged that new treatment for ischemic heart disease is not necessary, it is
 qualified.

 17. The latest inspection value within 14 days before registration (possible on the same
 day two weeks before the registration date) satisfies all of the following.

 I. White blood cell count ≧4,000/mm3 II. Hemoglobin ≥ 11.0 g/dL (no blood transfusion
 within 14 days before the blood sampling date of the test used for registration) III.
 Platelet count ≧10×104 /mm3 IV. Total bilirubin ≤ 2.0 mg/dL V. AST ≤ 75 U/L VI. ALT ≤
 75 U/L VII. Serum creatinine ≤ 1.2 mg/dL

 18. Written informed consent from the patient to participate in the study.

 19. The attending physician can judge that the enrolled patients understand the treatment
 and evaluation schedule of this study and can comply with them.

 Exclusion Criteria:

 1. Having active double cancer (simultaneous double cancer/multiple cancer and
 metachronous double cancer/multiple cancer with a disease-free period of 3 years or
 less, even if the disease-free period is less than 3 years, clinical The 5-year
 relative survival rate is similar to that of stage I prostate cancer, clinical stage 0
 completely responded to radiation therapy, stage I laryngeal cancer, and complete
 excision of the following pathological stage cancers. History of cancer equivalent to
 95% or more is not included in active double cancer/multiple cancer). Gastric cancer
 "adenocarcinoma (general type)": Stage 0-I, colon cancer (adenocarcinoma): Stage 0-I,
 rectal cancer (adenocarcinoma): Stage 0-I, esophageal cancer (squamous cell carcinoma,
 glandular) Squamous cell carcinoma, basal cell carcinoma): Stage 0, breast cancer
 (non-invasive ductal carcinoma, lobular carcinoma): Stage 0, breast cancer (invasive
 ductal carcinoma, lobular invasive carcinoma, Paget's disease): 0 Stage-IIA,
 endometrial cancer (endometrioid adenocarcinoma, mucinous adenocarcinoma): Stage I,
 prostate cancer (adenocarcinoma): Stage I-II, cervical cancer (squamous cell
 carcinoma): Stage 0, thyroid cancer (Papillary cancer, follicular cancer): stage I,
 stage II, stage III, renal cancer (clear cell carcinoma, chromophobe cell carcinoma):
 stage I, non-melanoma skin cancer, malignant melanoma without a definite diagnosis,
 etc. Lesions of intramucosal cancer

 2. Has an infectious disease that requires systemic treatment (including active pulmonary
 tuberculosis).

 3. When registering, a fever of 38.0°C or higher is generated.

 4. Women who are pregnant, possibly pregnant, within 28 days of delivery, or
 breastfeeding. A man who wants a partner to become pregnant. Or a reproductive male or
 female patient who is not willing to use an effective contraceptive by Week 13 (Day
 91) after the last dose of durvalumab (see 6.4.7.).

 5. Participation in the study is considered to be difficult due to the combination of
 mental illnesses or symptoms that impair daily life.

 6. Continuous systemic administration (oral or intravenous) of steroid drugs or other
 immunosuppressive drugs in excess of 10 mg/day in terms of prednisolone.

 7. With uncontrolled diabetes.

 8. With uncontrolled hypertension.

 9. A gastrointestinal disorder accompanied by uncontrolled diarrhea.

 10. With unstable angina (angina with onset or exacerbation of attack within the last 3
 weeks) or a history of myocardial infarction within 6 months.

 11. Poor valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy,
 congestive heart failure, and arrhythmia.

 12. Chest CT reveals severe emphysema.

 13. Either HBs antigen, HCV antibody, or HIV1/2 antibody is positive.

 14. Continuous use of flucytosine (Ancotil®) is required.

 15. Participating in another clinical trial (excluding observational studies) during the 6
 months prior to enrollment.

 16. A history of allogeneic organ transplant.

 17. A history of active primary immunodeficiency.

 18. Live vaccines (BCG, polio, measles-rubella mixture, measles, rubella, mumps,
 chickenpox, yellow fever, rotavirus, etc.) have been administered within 30 days
 before registration.

 19. Has hypersensitivity or allergy to the test drug or its additives used in this test.