JCOG1807C: Efficacy and safety of durvalumab before and after operation after chemoradiotherapy against superior sulcus non-small cell lung cancer

JRCT ID: jRCTs031190223

Registered date:01/03/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: superior sulcus non-small cell lung cancer
• Date of first enrollment: 30/10/2020
• Target sample size: 79
• Study type: Interventional

Intervention(s)

<Induction therapy>
1. CDDP + S-1 therapy (2 courses) + Chest radiation therapy (66 Gy / 33 Fr)
2. Preoperative durvalumab treatment

<Operable>
1. Surgical treatment
2. Postoperative durvalumab treatment

<Inoperable>
1. Additional durvalumab treatment

Outcome(s)

• Primary Outcome: 3-year survival rate
• Secondary Outcome: 3-year progression-free survival, 5-year progression-free survival, 5-year survival, recurrence type, proportion of local recurrence, response rate to preoperative adjunctive therapy (response rate), proportion of performing surgical treatment, proportion of pathological complete resection, pathological complete response rate (complete response rate), major pathological response rate, operation time, blood loss, adverse event, serious adverse event

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

(1) Histologically or cytologically (including biopsy) confirmed non-small cell lung cancer.
(2) All the following are satisfied (UICC-TNM classification 8th edition).
(i) For primary site, chest CT meets any of the following.
a. Direct invasion to the apical chest wall
b. Direct invasion to subclavian artery or subclavian vein
(ii) For regional lymph nodes, satisfy either of the following by chest CT and FDG-PET / CT.
a. cN0
b. cN1 and lymph node metastasis to #13 and/or #14
c. cN3, same side supraclavicular lymph node metastasis and no lymph node metastasis to contralateral mediastinal, contralateral hilar, ipsilateral/contralateral scalene, #10 #11, #12, cN2 (ipsilateral mediastinal, subcarinal lymph nodes) (#13 or #14 lymph node metastasis is eligible)
In b. and c., hilum is not irradiated.
(iii) Distant metastasis (including intrapulmonary metastasis within the same lung lobe and ipsilateral lung lobe) is not found in imaging including FDG-PET/CT
(3) It is judged that radical resection is possible by lobectomy (including bi-lobectomy)
(4) Consult with the radiation oncologist and it is judged that all the following conditions are met.
(i) Radiation therapy is possible according to the protocol
(ii) The radiation field does not reach the hilar region
(5) Over 20 years old and under 75 years old.
(6) An Eastern Cooperative Oncology Group performance status (PS) of 0 or 1
(7) It does not matter whether or not there are measurable lesions.
(8) Whether benign or malignant, there is no history of surgery below.
(i) A history of surgery by thoracotomy, thoracoscopy involving the ipsilateral lung, esophagus or mediastinum.
(ii)A history of surgery by median sternotomy.
(ii) A history of lung resection other than wedge resection of the contralateral lung (whether thoracotomy or thoracoscopic surgery).
(9) No history of chemotherapy, including treatment for other cancer types.
(10) If patients have a history of radiation therapy including other cancer types, lung, hilar, mediastinum and supraclavicular region are not included in the radiation field.
(11) Chest CT does not show interstitial pneumonia or pulmonary fibrosis.
(12) No complication of autoimmune disease or a history of chronic or recurrent autoimmune disease.
(13) No surgical treatment with general anesthesia within 14 days (2 weeks) before enrollment.
(14) Have not received systemic administration of steroids, other immunosuppressants, or immunoglobulin within 28 days (4 weeks) before registration.
(15) Sufficient oral intake
(16) The latest 12-lead electrocardiogram within 28 days before enrolment shows no ischemic changes.
(17) Latest test value within 14 days before enrolment meets all the following.
(i) WBC >= 4,000/mm3
(ii) hemoglobin >= 11.0 g/dL
(iii) platelet count >= 100000/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 has been obtained from patients themselves regarding study participation.
(19) Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Exclude criteria

(1) Having active double cancer (synchronous double cancer / multiple cancer and metachronous double cancer / multiple cancer with disease-free period of 3 years or less.
(2) Have an infection including tuberculosis that requires systemic treatment.
(3) Body temperature >= 38.0 degrees Celsius at the time of registration.
(4) Women who are pregnant, have a possibility of becoming pregnant, fall within 28 days postpartum, or breastfeeding. Men who are planning for conception.
(5) Severe mental disease
(6) Receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressive drugs.
(7) Have an uncontrolled diabetes.
(8) Have an uncontrolled hypertension.
(9) Have a gastrointestinal disease accompanying uncontrollable diarrhea.
(10) Have an unstable angina pectoris (angina pectoris with onset or seizure progression within the last 3 weeks) or having a history of myocardial infarction within 6 months.
(11) Have an uncontrolled valvular disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, congestive heart failure or arrhythmia.
(12) Chest CT shows severe pulmonary emphysema.
(13) Positive HBs antigen, HBC angigen or HIV1/2 antigen.
(14) The continuous use of flucytosine (Ancotyl) is required.
(15) Participated in another clinical trial using the investigational drug for 6 months before enrollment.
(16) History of allogeneic organ transplantation.
(17) History of active primary immune deficiency.
(18) Live vaccine (BCG, polio, measles-rubella mixed, measles, rubella, epidemic parotitis, varicella, yellow fever, rotavirus etc.) within 30 days before registration.
(19) Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.

Related Information

• Primary Sponsor: TSUBOI Masahiro
• Secondary Sponsor: AstraZeneca K.K.
• Source(s) of Monetary Support: National Cancer Center Japan,Japan Agency for Medical Research and Development