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

NCT ID: NCT05460195

Last Updated: 2022-07-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination therapy group

Sintilimab combined with anlotinib

Group Type: EXPERIMENTAL

sintilimab combined with anlotinib

Intervention Type: DRUG

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.

Single-agent therapy group

Sintilimab monotherapy

Group Type: EXPERIMENTAL

sintilimab monotherapy

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

immunotherapy combined with antiangiogenic therapy; immunotherapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tianqing Chu

Associate Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tianqing Chu Chu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Chest Hospital

Locations

Shanghai Chest Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Tianqing Chu

Role: CONTACT

tianqing_chu@126.com

13661775640

Facility Contacts

Changqing Pan

Role: primary

Other Identifiers

ChestKS22002

Identifier Type: -

Identifier Source: org_study_id