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

Phase 2

Recruiting

• Conditions: Minimal Residual Disease; Anti-angiogenesis; Non-small Cell Lung Cancer; Immunotherapy
• Interventions: Drug: sintilimab monotherapy; Drug: sintilimab combined with anlotinib

• Registration Number: NCT05460195
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-07
• Study First Submitted: 2022-07-03
• Study First Submitted QC: 2022-07-14
• Last Update Submitted: 2022-07-14
• Study First Posted: 2022-07-15
• Last Update Posted: 2022-07-15
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-agent therapy group	sintilimab monotherapy	Sintilimab monotherapy
Combination therapy group	sintilimab combined with anlotinib	Sintilimab combined with anlotinib

Primary Outcome Measures

Name	Time	Method
Major pathologic response (MPR)	2 months	Residual tumor cells of the surgical specimens were ≤10% based on pathological evaluation.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	32 months	Radiographic assessments were performed when enrolled and every 8 weeks until disease progression after chemotherapy according to RECIST version 1.1. After PD, collect the survival information every 16 weeks until death or withdrawal of study consent.
Event free survival (EFS)	16 months	Time from randomization to any of the following: disease progression; new primary NSCLC; death from any cause
Complete pathologic response (CPR)	2 months	Residual tumor cells of the surgical specimens were 0% based on pathological evaluation.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, China