Sintilimab Combined With Anlotinib for Perioperative Non-small Cell Lung Cancer Based on MRD Evaluation

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 2

Conditions: Immunotherapy; Non-small Cell Lung Cancer; Anti-angiogenesis; Minimal Residual Disease

Treatments: Drug: sintilimab monotherapy; Drug: sintilimab combined with anlotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT05460195

ChestKS22002

Details and patient eligibility

About

To study the efficacy of sintilimab combined with anlotinib for perioperative non-small cell lung cancer. To explore the clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease.

Full description

Patients with resectable non-small cell lung cancer (NSCLC) have a high postoperative recurrence rate. Perioperative treatment, which can improve the resection rate and clear the minimal residual disease, is the main mean of preventing recurrence, including preoperative neoadjuvant and postoperative adjuvant therapies. In recent years, immunotherapy can significantly improve the pathological remission rate and prolong the survival as a perioperative treatment. In addition to single-agent or combined chemotherapy, the exploration of immunotherapy with other therapeutic strategies is still lacking.

In 2018, we originally designed sintilimab combined with anlotinib in the first-line treatment of advanced NSCLC.

This clinical study plans to: ① apply the "de-chemotherapy" model to the perioperative phase of early NSCLC, ② explore sintilimab combined with anlotinib in preoperative neoadjuvant and postoperative adjuvant therapies, ③ explore clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease (MRD), in order to improve the efficacy of perioperative NSCLC and prolong survival.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cyologically confirmed stage II-IIIa NSCLC patients;
• NSCLC patients with negative driver gene: EGFR wild-type, no ALK fusion mutation, no ROS1 fusion mutation;
• ECOG PS: 0~1;
• Pulmonary function index meets the surgical criteria;
• No previous systemic anti-tumor treatment.

Exclusion criteria

• Patients with central cavitary squamous cell carcinoma or investigator-assessed bleeding symptoms or bleeding tendency were excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Combination therapy group

Experimental group

Description:

Sintilimab combined with anlotinib

Treatment:

Drug: sintilimab combined with anlotinib

Single-agent therapy group

Experimental group

Description:

Sintilimab monotherapy

Treatment:

Drug: sintilimab monotherapy