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
A definite diagnosis of non-small cell lung cancer has been obtained by biopsy from the primary lesion.
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.
It is judged that radical resection is possible by lobectomy (including bilobectomy for 2 lobes), which satisfies the following [1] and [2].
Consult with the radiotherapy doctor and it is judged that all of the following are met.
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
Has an infectious disease that requires systemic treatment (including active pulmonary tuberculosis).
When registering, a fever of 38.0°C or higher is generated.
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.).
Single group
Cisplatin
DrugCisplatin 60 mg/m2, IV, day 1
S1
Drug80 - 120 mg/day, PO, day 1-14
concurrent radiotherapy
Radiation66 Gy/33 Fr
Durvalumab
Drugpreoperative durvalumab therapy within 28 days after chemoradiotherapy. Two courses are given every two weeks.
Surgery
Procedure/SurgerySurgery will be performed between day 15 and day 42 of the second course of preoperative durvalumab therapy after confirming that all surgical operation criteria are met.
Durvalumab
Drug(For resectable SST) Postoperative durvalumab therapy will be started between day 28 and day 63 with the day of surgery as Day 1. Twenty-two courses are given as a 2-week course. Drug: Durvalumab 10 mg/kg/body, IV, day 1 (For unreectable SST) Additional durvalumab therapy between day 15 and day 28 of the second course of preoperative durvalumab therapy. Twenty-two courses are given as 2-week course. Drug: Durvalumab 10 mg/kg/body, IV, day 1
3-year overall survival rate (3y-OS)
3-year overall survival rate
3-year progression-free survival rate (3y-PFS)
3-year progression-free survival rate
5-year progression-free survival rate (5y-PFS)
5-year progression-free survival rate
5-year overall survival rate (5y-OS)
5-year overall survival rate
Mode of recurrence
Mode of recurrence in surgical cases
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National Cancer Center Hospital East
Lead sponsor
AstraZeneca
Collaborator
Japan Agency for Medical Research and Development
Collaborator
Japan Clinical Oncology Group
Collaborator
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