Neoadjuvant With Tα1 Plus Immuno-chemotherapy for Resectable NSCLC
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorXuanwu Hospital, Beijing
About this trial
This study aims to explore the efficacy and safety of thymosin α-1 (Tα1) plus chemotherapy and PD-1 inhibitors as neoadjuvant therapy for operable non-small cell lung cancer
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Males and females aged ≥ 18 years and ≤ 70 years
With operable NSCLC confirmed by imaging studies and histopathology. (Stage II-IIIB[N2], according to the 8th Edition of the American Joint Committee on Cancer (AJCC-TNM) Staging Manual). Operable NSCLC, as defined by the Multidisciplinary Consensus Statement on the Clinical Management of Patients with Stage III Non-Small Cell Lung Cancer (2019 edition), includes resectable and potentially resectable cases. Resectable stage III NSCLC mainly includes stage IIIA N0-1, N2 with a single mediastinal lymph node metastasis and a short diameter < 2 cm and some T4N1 (with solitary carcinomatous nodules in different lobes of the same lung). Potentially resectable stage III NSCLC includes some IIIA and IIIB tumors, usually including a single N2 mediastinal lymph node with a short diameter < 3 cm, a potentially resectable superior sulcus tumor, and a potentially resectable T3 or T4 central tumor.
Presence of at least one measurable lesion on imaging as per the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Negative for EGFR and ALK driver mutations
Disqualifiers
History of other malignancies within 5 years prior to the initial dose, excluding radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ following radical resection.
Positive for EGFR and ALK driver mutations or unknown
Ongoing participation in another interventional clinical trial, or receipt of other investigational agents or devices within 4 weeks prior to the first dose.
Prior multidisciplinary treatment for lung cancer, including but not limited to surgery, radiotherapy, chemotherapy, and/or immunotherapy (e.g., PD-1 or PD-L1 inhibitors and CTLA-4 inhibitors).
Trial design
Design model
Parallel
Treatments tested in this trial
Thymosin Alpha 1
Drug4.8 mg subcutaneous injection twice weekly over 12 weeks
Tislelizumab
Drug200mg, IV, d1 of each 21-d cycle, four cycles
Platinum-doublet chemotherapy
DrugChemotherapy regimen: (1) for squamous cell carcinoma: cisplatin/carboplatin + paclitaxel; and (2) for non-squamous cell carcinoma: cisplatin/carboplatin + pemetrexed.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Control groupActive comparator 2 interventions
Group B: Experimental groupExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Pathologic complete response rate
The rate of no viable tumor cells in the resected specimen including lymph node region evaluated by H\&E staining
Time frame
at the time of surgeySecondary outcomes
1
major pathological response rate
The rate of ≤ 10% viable tumor cells in the resected specimen evaluated by H\&E staining
Time frame
at the time of surgey2
Rate of R0 resection
The rate of participants undergoing R0 resection
Time frame
at the time of surgey3
Incidence of irAE
The occurrence rate of immune-related adverse events
Time frame
From the first dose of PD-1 inhibitors to the three months after surgerySponsors and contacts
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Source ClinicalTrials.gov
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