In recent years, immune checkpoint inhibitors targeting cytotoxic T-lymphocyte antigen-4, programmed death-1, and programmed death-ligand 1 have achieved milestones in the treatment of NSCLC, from back-line to first-line, and beyond. Is changing the standard of care for NSCLC. Currently, several phases Ⅲ clinical studies of neoadjuvant immunity combined with standard chemotherapy are underway, suggested that neoadjuvant ICI therapy is a promising way for locally advanced lung cancer. As an intermediate state in the process of tumor metastasis, Oligometastatic NSCLC patients have a better prognosis and more likely to benefit from local treatment than patients with extensive distant metastasis. However, there have been few reports of salvage surgery after ICI treatment in Oligometastatic NSCLC, and only one case has been reported to date. There is therefore a need to further gather evidence on salvage surgery after ICI.
This is a single-center, single-arm, prospective phase II study to evaluate the efficacy and safety of toripalimab in combination with platinum-based and surgery in patients with mutation-negative stage IV Oligometastatic NSCLC.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Toripalimab will be administered at a fixed dose of 80 mg (2ml)/vial, IV, D1, with a full dose of 240 mg at one time, every 3 weeks for 3-4 cycles. Squamous cell carcinoma will be combined with cisplatin/carboplatin and Nab-paclitaxel: carboplatin, AUC=5, D1, IV, q3w, or cisplatin, 75 mg/m2, IV, q3w, and Nab-paclitaxel, 130 mg/m2, D1, IV, q3w, for 3-4 cycles. Non-squamous cell carcinoma will be combined with cisplatin/carboplatin and Pemetrexed, cisplatin/carboplatin is the same as above, Pemetrexed will be given at 500 mg/m2, D1, IV, q3w, for 3-4 cycles.
After the last treatment (Day 21 of Cycle 4), surgery was performed within 4-6 weeks.
Postoperatively, a comprehensive evaluation will be conducted by the investigator, and the intention will receive maintenance therapy within 6-12 weeks of the MDT assessment. Toripalimab: a fixed dose of 80 mg (2ml)/vial, IV, D1, a full dose of 240 mg at one time, every 3 weeks administered until PD or intolerable toxicity, for a maximum duration of 1 year.
The Fourth Military Medical University Tangdu Hospital
Xi'an, Shaanxi, China
RECRUITINGProgress Free Survival(PFS)
Progress Free Survival is defined as included the development of new metastases, or local progression of metastases or primary lesions that underwent surgical resection/radiotherapy and will be assessed according to RESIST 1.1 criteria.
Time frame: the time from the date of the operation until the first recurrence or the last follow-up(Up to approximately 26 months).
Pathological complete response(pCR)
Pathological complete response is defined as 0% survival of tumor cells in surgically resected primary and metastatic tumor samples (excluding brain and bone metastases) after neoadjuvant therapy, as assessed by tumor regression grade.
Time frame: after 3-4 cycles of neoadjuvant therapy (At the day of surgery)
Main pathology rate(MPR)
Main pathology rate is defined as survival of tumor cells ≤ 10% in surgically resected primary and metastatic tumor samples (excluding brain and bone metastases) after neoadjuvant therapy, assessed by tumor regression grade.
Time frame: after 3-4 cycles of neoadjuvant therapy (At the day of surgery)
Objective Response Rate (ORR)
Objective Response Rate is defined as complete response (CR) + partial response (PR), from the beginning of regimental therapy to the end of neoadjuvant therapy, the efficacy of baseline target lesions (primary + metastatic) was assessed by RECIST1.1 criteria.
Time frame: after 3-4 cycles of neoadjuvant therapy(Up to approximately 26 months).
Assess adverse events
Assess all adverse events according to the NCI Common Terminology Criteria for (NCI-CTCAE) v 4.0.3.
Time frame: the time from the neoadjuvant until the last follow-up(Up to approximately 26 months).
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