Clinical trials

The goal of this clinical trial is to evaluate the effectiveness and safety of a locally deployed artificial intelligence (AI) decision-support model in the multidisciplinary team (MDT) process for patients with non-small cell lung cancer (NSCLC). The main questions it aims to answer : What is the level of agreement between treatment recommendations generated by the AI model and those made by a traditional MDT? How often do clinicians modify their final treatment decision after reviewing the AI model's recommendation? Researchers will compare treatment plans from the traditional MDT (Arm 1), the AI model (Arm 2), and the clinician's final decision after reviewing the AI output (Arm 3) to assess consistency, decision modification rates, and clinical efficiency. Participants will: Have their clinical, imaging, and molecular data submitted to both the traditional MDT and the AI model for independent treatment recommendations Receive a final treatment plan determined by clinicians after reviewing both recommendations, with follow-up for safety and survival outcomes

The SCIENCE trial is a multicenter, open-label, randomized, parallel, noninferiority investigator-initiated trial (IIT). This study aims to evaluate the prognostic differences between selective mediastinal lymph node sampling and systematic mediastinal lymph node dissection in patients with node-negative stage IIA to IIIB (N2) non-small-cell lung cancer (NSCLC) undergoing anatomical lobectomy following neoadjuvant chemoimmunotherapy.

This study is a prospective, randomized controlled multicenter clinical trial. The study population consisted of non-small cell lung cancer（NSCLC） patients in stage IIA-IIIB (IASLC 9th edition) who received immunotherapy combined with platinum based dual drug chemotherapy before neoadjuvant therapy and were evaluated by the committee to be feasible for sub lobectomy R0 resection. After entering the study, they were randomly divided into a sub lobectomy group (study group) and a lobectomy group (control group). Follow up will be conducted after surgery. The study includes screening/baseline period, perioperative period, and follow-up period. Screening/Baseline Period: The screening period is 28 days prior to receiving surgery. After the patient signs the informed consent form (ICF), the inclusion and exclusion criteria are reviewed during the screening/baseline period to include patients who meet the inclusion and exclusion criteria, with specific reference to the inclusion and exclusion criteria. During the screening period of this study, if laboratory and imaging tests that do not meet the inclusion criteria are found during the first screening, patients are allowed to undergo re examination and re screening. When re screening, informed consent must be signed and a new participant screening number must be obtained through re registration. Perioperative period: During the perioperative period, patients were randomized into a sub lobectomy group (study group) and a lobectomy group (control group). The research group used thin-layer CT imaging and 3D reconstruction to accurately plan the surgical resection range before surgery, and underwent subpulmonary lobectomy+hilar/mediastinal lymph node dissection; The control group patients underwent direct lobectomy and lymph node dissection of the pulmonary hilum/mediastinum. Follow up period: The follow-up period includes a safety follow-up period and a survival follow-up period. Safety follow-up will be conducted 30 days (+5 days) after surgery or before receiving the first postoperative adjuvant therapy medication. Survival follow-up will be conducted every 3 months (± 14 days) in the first year after surgery and every 6 months (± 14 days) in the second year after surgery. Participants' chest CT scan results, survival status, follow-up anti-tumor treatment, and drug-related SAEs (including lung function tests at 6 months, 12 months, and 3 years after surgery) will be collected until the 3-year follow-up time/(participant death, loss to follow-up, voluntary withdrawal from clinical study, or end of study) (whichever occurs first). The research plan can be found in the research flowchart. Main objective: Evaluate the prognostic differences between sub lobectomy and lobectomy in NSCLC patients after neoadjuvant immunotherapy and chemotherapy; Secondary objective: 1\. Evaluate the lung function preservation of NSCLC patients after neoadjuvant immunotherapy and chemotherapy with sub lobectomy compared to lobectomy; Evaluate the safety of sub lobectomy compared to lobectomy in NSCLC patients after neoadjuvant immunotherapy and chemotherapy, including postoperative complications, length of hospital stay, etc; Evaluate the postoperative quality of life of NSCLC patients after neoadjuvant immunotherapy and chemotherapy with sub lobectomy compared to lobectomy.

This is a multicenter, phase 2 non-randomized study to investigate the clinical feasibility and therapeutic efficacy of employing a MDT-based strategy in unresectable stage III ALK positive NSCLC following neoadjuvant alectinib in combination with platinum-based chemotherapy. Participants in this study must not have received any previous systemic anticancer therapy before enrollment. The study will consist of a 42-day screening period, a neoadjuvant treatment period, a local radical treatment period, a post-local treatment period, a safety follow-up visit occurring 28 days after the final dose of alectinib, and a survival follow-up period. In the neoadjuvant treatment period, participants will be provided with alectinib (600mg PO BID for 3 cycles) plus platinum-based chemotherapy for a maximum of 3 cycles (each cycle is 21 days). Following the completion of neoadjuvant therapy, all participants who are reassessed by MDT to be resectable after neoadjuvant treatment and have adequate lung functions would be provided with definite surgery. Otherwise, patients would be provided with radical radiotherapy through MDT discussion. For the surgery cohort, participants meet both the R0 resection, the pathological assessment criteria of pCR and have two consecutive landmark ctDNA tests that are negative will receive surveillance after surgery. Participants who do not meet all the above conditions will receive alectinib after surgery, adjuvant treatment should be initiated ideally 4-12 weeks after surgery, or according to local standard of care, treatment will continue until completion of treatment period (24 months), disease recurrence, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first. For the radical radiotherapy cohort, participants will receive alectinib after radiotherapy, adjuvant treatment should be initiated ideally 4-12 weeks after surgery, or according to local standard of care, the treatment will continue until completion of treatment period (24 months), disease progression, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.

This is a two-cohort, multicenter, Phase II study to evaluate the efficacy and safety of 3-4 cycles of toripalimab (JS001) plus chemotherapy followed by toripalimab maintenance treatment up to one year in participants with completely resected non-small cell lung cancer (NSCLC) stratified by prior neoadjuvant treatment status, as measured by disease-free survival (DFS) and overall survival (OS). Researchers will compare outcomes between two cohorts: 1. Cohort 1: Stage IB-IIIB participants following completely resection without neoadjuvant therapy; 2. Cohort 2: Stage IIB-III participants with non-MPR or MPR but lymph node positivity after neoadjuvant therapy.

This clinical trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Limertinib Followed by Sintilimab and Chemotherapy in resectable Stage II-IIIB EGFR-Mutant NSCLC. Untreated stage II-IIIB NSCLC (AJCC 8th edition) patients assessed as surgically resectable by investigators will be randomized 1:1 into the experimental or control group after signing informed consent and meeting eligibility criteria. All patients receive Limertinib for 6 weeks. Within 7 days thereafter, imaging assessment will be performed. If no progression is observed, experimental group patients discontinue therapy for 1 week, then receive Sintilimab + Carboplatin/Cisplatin + Pemetrexed every 3 weeks for 3 cycles; control group patients receive Limertinib for 9 weeks and Carboplatin/Cisplatin + Pemetrexed every 3 weeks for 3 cycles. Preoperative tumor assessment is required. Surgery will be performed 2-6 weeks (±7 days) after the first dose of the final cycle. Then patients will recieve 2-year adjuvant Osimertinib starting 1 month post-surgery. If imaging assessment after 6 weeks of limertinib treatment shows lesion enlargement but remains confined to stage II-IIIB, the investigator will decide whether the patient continues study treatment or not; if progression occurs to unresectable stage III or advanced disease, the patient must discontinue. The primary endpoint is pathological complete response (pCR) rate.