Clinical trials

The primary objective is to evaluate the correlation between ⁶⁸Ga-MY6349 PET/CT-derived metrics reflecting tumoral TROP2 expression activity (including SUVmax, SUVmean, MTV, TLG, etc.) and progression-free survival (PFS) assessed per RECIST v1.1. This study plans to enroll 100 EGFR-mutant patients with advanced non-small cell lung cancer (NSCLC) who have developed resistance following first-line therapy with third-generation EGFR-TKIs. Screening assessments will be completed within 28 days after patients sign the informed consent form. Eligible subjects will undergo a baseline ⁶⁸Ga-MY6349 PET/CT scan prior to study drug administration, with imaging coverage from mid-thighs to the vertex of the skull. All subjects will receive a ¹⁸F-FDG PET/CT scan within 14 days after the ⁶⁸Ga-MY6349 PET/CT. For patients who have undergone ¹⁸F-FDG PET/CT within 14 days before the ⁶⁸Ga-MY6349 scan, the existing imaging data can be used for diagnostic performance evaluation, and repeat ¹⁸F-FDG PET/CT is not required. Subsequently, subjects will receive monotherapy with sacituzumab govitecan at a dose of 5 mg/kg via intravenous infusion (IV) on Day 1 of each cycle, administered every 2 weeks (Q2W). Treatment will continue until investigator-confirmed radiological disease progression, intolerable adverse toxicity, voluntary treatment discontinuation by the subject, or any other protocol-specified treatment discontinuation criterion, whichever occurs first. At 3 months after initiation of sacituzumab govitecan treatment, subjects will repeat the ⁶⁸Ga-MY6349 PET/CT scan (coverage: mid-thighs to vertex), followed by a ¹⁸F-FDG PET/CT examination within 14 days thereafter. Eligible subjects will receive regular tumor assessments in accordance with RECIST v1.1. Within 48 weeks after the first dose, imaging-based tumor assessments will be performed every 6 weeks (±7 days). At Week 12 (±1 week), paired ⁶⁸Ga-MY6349 and ¹⁸F-FDG PET/CT scans will be conducted without routine diagnostic CT. After Week 48, tumor assessments will be scheduled every 12 weeks (±7 days) until radiological disease progression, initiation of subsequent anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or study termination by the sponsor, whichever comes first. Imaging assessments will follow the predetermined schedule regardless of dose delays or dose modifications. After the first documented complete response (CR) or partial response (PR), response confirmation imaging must be conducted no less than 4 weeks (28 days) later. For subjects discontinuing treatment for reasons other than radiological progression, death or loss to follow-up, if more than 4 weeks have passed since the last imaging evaluation, repeat imaging will be performed at the End-of-Treatment (EOT) visit. Subsequent imaging assessments will be conducted per schedule to the greatest extent feasible until radiological disease progression, initiation of new anti-tumor therapy, consent withdrawal, loss to follow-up, death, or sponsor-initiated study termination, whichever occurs earliest. All ⁶⁸Ga-MY6349 PET/CT images will be blindly and independently reviewed by two experienced nuclear medicine physicians who are not involved in this clinical trial (without access to any clinical data) to identify positive NSCLC lesions, as well as lesion location and count. In case of disagreement between the two independent readers regarding the presence of positive lesions, a blinded arbitration review by a senior nuclear medicine expert will be activated, and the arbitrator's reading results will serve as the final conclusion. All ¹⁸F-FDG PET/CT images will undergo single blinded independent review by one nuclear medicine physician. Upon completion of treatment, all subjects will complete safety follow-up regardless of whether they receive subsequent anti-tumor therapy. Telephone-based survival follow-up visits will be conducted every 3 months (±14 days) after the last dose of study treatment to collect survival status and information on subsequent anti-tumor treatments, until subject withdrawal, loss to follow-up, death, or study closure, whichever occurs first.

Study Objectives The primary objective of Phase II is to evaluate the percentage of lesion resolution on high-resolution computed tomography (HRCT) as assessed by independent blinded reviewers. Secondary objectives include evaluating effects on pulmonary function, exercise capacity, dyspnea, quality of life, and oxygenation, as well as comprehensively assessing safety and tolerability. Phase I focuses on determining safety, dose-limiting toxicities (DLT), and recommended Phase II dose. Study Population The target population is patients with non-acute CIP aged 18-75 years with histologically confirmed malignancy. Key inclusion criteria include: At least one cycle of immune checkpoint inhibitor (ICI) therapy and development of Grade 3-4 CIP per NCCN Guidelines V1.2025 Standard glucocorticoid treatment for ≥4 weeks, with current dose \<20 mg/day prednisone equivalent or discontinued Persistent residual CIP lesions on HRCT without significant improvement in the past 4 weeks ECOG PS 0-1 and stable primary tumor for ≥6 months Effective contraception during the study and for 360 days after last dosing Key exclusion criteria include: Concomitant use of pirfenidone, nintedanib, or other antifibrotic agents Inability to perform pulmonary function tests or tolerate nebulization Unresolved interstitial lung disease from radiotherapy or targeted therapy Severe cardiac, hepatic, renal, or hematological dysfunction Organ transplantation, severe immunodeficiency, active epilepsy, or severe allergic status Other investigational drug use within 28 days Study Design and Sample Size Phase I: 9-18 subjects, open-label, dose-escalation design to evaluate DLT and safety Phase II: 40 subjects, randomized, double-blind, placebo-controlled design Study Endpoints Phase I Primary Endpoints Incidence of DLT Incidence of adverse events (AE) and serious adverse events (SAE) Phase II Primary Endpoint Percentage of HRCT lesion resolution at Weeks 4, 12, and 24, assessed by independent blinded reviewers Secondary Endpoints Pulmonary function: FVC%, TLC, RV, FRC, DLCO Functional and symptomatic measures: 6MWD, mMRC dyspnea score, SGRQ, LCQ Oxygenation: PaO₂, A-aDO₂, oxygenation index Exploratory Endpoints Dynamic changes in serum biomarkers: KL-6, cytokines (IL-1β, IL-6, IL-10), immune cell subsets (Tregs, Th1/Th17) Safety Assessments Monitoring of AEs/SAEs graded by CTCAE v5.0 and causality assessment Physical examination, vital signs, SpO₂, 12-lead ECG Laboratory tests: CBC, biochemistry, coagulation, urinalysis, CRP, ESR Study Termination Rules Overall Study Termination Successful completion after all 40 subjects finish 24-week follow-up and database lock Occurrence of unexpected serious or unacceptable safety risks Demonstration of overwhelming efficacy or futility Sponsor termination due to slow enrollment, funding, or major protocol deviations Regulatory or ethics committee requirements Individual Subject Discontinuation Development of DLT or severe hypersensitivity Rapid CIP progression (e.g., \>50% radiological worsening) Tumor progression or clinical deterioration Withdrawal of informed consent Poor compliance unresponsive to intervention Loss to follow-up or death Investigator judgment of inappropriateness for continued participation Study Timeline Preparation and initiation: January 2026 - May 2026 Phase I/II enrollment: June 2026 - May 2027 Treatment and follow-up (overlapping with enrollment): through June 2028 Database lock and statistical analysis: July 2028 - August 2028 Study closeout: August 2028 - December 2028

Checkpoint inhibitor-related pneumonitis (CIP) is a common fatal immune-related adverse events of PD-1/PD-L1 inhibitors. Early diagnosis of CIP is crucial for timely intervention and improved prognosis; however, the absence of precise and effective diagnostic techniques often leads to underdiagnosis and misdiagnosis. The investigators conducted a prospective clinical study to evaluate the effectiveness of ¹H-nuclear magnetic resonance (NMR)-based lipoprotein and metabolite analysis in diagnosing checkpoint inhibitor-related pneumonitis (CIP), aiming to improve its early diagnosis rate.

The goal of this clinical trial is to learn if hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb works to treat extensive-stage small-cell lung cancer in adults. It will also assess the safety of this treatment approach. The main questions it aims to answer are: Does hematopoietic stem cell transplantation-supported dose-dense chemotherepy with adebrelimb improve the median progression free survival and 12-months overall survival rates? What medical problems do participants experience whild undergoing this treatment? Participants will: Complete two 21-days cycles of standard-dose etoposide and carboplatin, followed by G-CSF for stem cell mobilization. Receive dose-dense chemotherapy followed by autologous stem cell reinfusion for two 21-day cycles. If eligible, participants will receive etoposide and carboplatin plus adebrelimab for four cycles. Finally, participants may enter a maintenance phase with adebrelimab. Throughout the trial, participants will: Visit the clinic every 21 days for check-ups and tests. Imaging examination every 6 weeks. Followed up by telephone every 2 months

The goal of this clinical trial is to explore the safety and efficacy of cryoablation combined with carlizumab and apatinib in multiple primary lung cancer without known driver genes.Main included population criteria:Clinical and pathological diagnosis of multiple primary lung cancer;Three pulmonary nodules were diagnosed initially or before surgery, without lymph node metastasis;Male or female is 18 years old, and 75 years old;Up to one surgical resection treatment with 2 remaining pulmonary nodules, and postoperative pathology confirmed MIA or AIS and so on.The main questions it aims to answer is safety of cryoablation combined with carilizumab and apatinib in multiple primary lung cancer.Participants will take carplus with apatinib started 2-3 weeks after cryoablation. Carelizumab 200mg, q3w, apatinib 250mg, qd. Every 3 weeks is for one treatment cycle. Until PD, intolerable toxicity, death, patient withdrawal or investigator discretion requires termination.

The aim of this study was to evaluate the efficacy and safety of intratumoral injection of toluenesulfonamide(PTS) in combination with or without first-line chemoimmunization based on standard treatment for stage IV driver gene-negative non-small cell lung cancer.

Lung cancer is a malignant tumor with high incidence and mortality in China and the world, among which small cell lung cancer (SCLC) accounts for 13% to 17% of lung cancer, and about 250,000 patients are diagnosed with SCLC every year in the world, and nearly 200,000 people die from it. Due to the high degree of malignancy of SCLC, it is easy to develop distant metastasis in the early stage, and most of the patients are diagnosed in the late stage with poor prognosis. Although SCLC is sensitive to chemotherapy and radiotherapy and has a high remission rate after initial treatment, it is prone to secondary drug resistance and relapse. SCLC is a low-differentiated, high-grade neuroendocrine tumor that can be classified into limited-stage and extensive stage (ES-SCLC). Etoposide combined with cisplatin (EP regimen) or carboplatin (EC regimen), irinotecan combined with cisplatin (IP regimen) or carboplatin (IC regimen) are the basis of standard first-line therapy for ES-SCLC. Immunocombined chemotherapy has also become the first-line standard treatment for ES-SCLC, among which serplulimab + etoposide + carboplatin is recommended by CSCO guidelines for first-line treatment. Liposomal irinotecan is irinotecan encapsulated by liposomes, which has advantages in safety. The study is expected to achieve good efficacy, improve the quality of life and prolong the survival of patients by combining the immune drug serplulimab on the basis of IC regimen. After replacing ordinary irinotecan with liposomal irinotecan, this study aims to compare the efficacy and safety of liposomal irinotecan + carboplatin + serplulimab with the first-line standard regimen (etoposide + carboplatin + serplulimab) in patients with extensive stage small-cell lung cancer, providing a better basis for clinical use.