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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05460195
• Other study ID #: ChestKS22002
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2022
• Source: Shanghai Chest Hospital
• Contact: Tianqing Chu
• Phone: 13661775640
• Email: tianqing_chu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Immunotherapy
• Lung Neoplasms
• Minimal Residual Disease
• Neoplasm, Residual
• Non-small Cell Lung Cancer

Intervention

Drug:
• sintilimab combined with anlotinib
Sintilimab (200mg/time, every 3 weeks) combined with anlotinib (12mg, once daily on day 1 to 14 per cycle) for 2 cycles (42 days). Radical surgery is performed within 4 - 6 weeks treatment. Sintilimab combined with anlotinib therapy repeats every 3 weeks until one year after surgery.
• sintilimab monotherapy
Sintilimab (200mg/time, every 3 weeks) combined with anlotinib (12mg, once daily on day 1 to 14 per cycle) for 2 cycles (42 days). Radical surgery is performed within 4 - 6 weeks treatment. Sintilimab monotherapy repeats every 3 weeks until one year after surgery.

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major pathologic response (MPR)	Residual tumor cells of the surgical specimens were =10% based on pathological evaluation.	2 months
Secondary	Complete pathologic response (CPR)	Residual tumor cells of the surgical specimens were 0% based on pathological evaluation.	2 months
Secondary	Event free survival (EFS)	Time from randomization to any of the following: disease progression; new primary NSCLC; death from any cause	16 months
Secondary	Overall survival (OS)	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.	32 months