Clinical trials

This single-arm phase II study aims to evaluate the efficacy and safety of lomustine combined with anlotinib in patients with extensive-stage small cell lung cancer resistant to second-line and above systemic treatment.

This is a single-arm, single-center, exploratory clinical study conducted at Shanghai Pulmonary Hospital, Tongji University. The study evaluates the effectiveness and safety of first-line treatment with benmelstobart (an immunotherapy), anlotinib (an anti-angiogenic drug), platinum-etoposide chemotherapy, and concurrent thoracic radiotherapy in participants with previously untreated, unresectable limited-stage small cell lung cancer (LS-SCLC). Eligible participants are aged 18 to 75 years, with histologically or cytologically confirmed limited-stage SCLC (VALG staging), no prior systemic treatment for lung cancer, measurable lesions by RECIST 1.1, ECOG performance status 0-1, and adequate organ function. Participants receive 4 cycles of induction therapy (21 days per cycle), including benmelstobart intravenously every 3 weeks, anlotinib orally for 2 weeks on / 1 week off, and chemotherapy with carboplatin or cisplatin plus etoposide. Thoracic radiotherapy (60-70 Gy in 30-35 fractions) is given concurrently with chemotherapy cycles 1-3. After induction, participants receive maintenance therapy with benmelstobart plus anlotinib for up to 2 years or until disease progression or unacceptable side effects. The primary objective is to assess the Objective Response Rate (ORR) as evaluated by investigators using RECIST 1.1. Secondary objectives include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety assessments of adverse events graded by CTCAE 5.0. A total of 27 participants will be enrolled. The study is expected to start in March 2026, complete enrollment by September 2027, and end in March 2029. All participants will be regularly followed for efficacy and safety.

This is a single-center, single-arm, exploratory clinical study conducted at Shanghai Pulmonary Hospital, Tongji University. It aims to evaluate the efficacy and safety of first-line treatment with benmelstobart plus anlotinib and chemotherapy (carboplatin/cisplatin plus etoposide), followed by sequential thoracic radiotherapy, in patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC). Eligible participants will be adults aged 18-75 years with histologically or cytologically confirmed ES-SCLC, measurable lesions per RECIST 1.1, ECOG performance status 0-1, and adequate organ function. Patients will receive 4 cycles of induction therapy (benmelstobart, anlotinib, platinum-etoposide chemotherapy). Those without disease progression will receive consolidative thoracic radiotherapy, followed by maintenance therapy with benmelstobart plus anlotinib until disease progression or unacceptable toxicity. The primary endpoint is objective response rate (ORR) assessed by investigators. Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety parameters including adverse events graded by CTCAE 5.0. A total of 33 subjects will be enrolled. This study uses a non-randomized, open-label design without a control group.