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

NCT05460195 | Unknown Phase 2

• 1 other identifier: ChestKS22002
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Major pathologic response (MPR)

  Residual tumor cells of the surgical specimens were ≤10% based on pathological evaluation.

  2 months

Secondary Outcomes (3)

• Complete pathologic response (CPR)

  2 months

• Event free survival (EFS)

  16 months

• Overall survival (OS)

  32 months

Study Arms (2)

Combination therapy group

EXPERIMENTAL

Sintilimab combined with anlotinib

Drug: sintilimab combined with anlotinib

Single-agent therapy group

EXPERIMENTAL

Sintilimab monotherapy

Drug: sintilimab monotherapy

Interventions

sintilimab combined with anlotinib 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.

Also known as: immunotherapy combined with antiangiogenic therapy

Combination therapy group

sintilimab monotherapy 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.

Also known as: immunotherapy

Single-agent therapy group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm, Residual

Interventions

anlotinib; Immunotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Tianqing Chu Chu

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tianqing Chu

CONTACT

13661775640; tianqing_chu@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: July 3, 2022
• First Posted: July 15, 2022
• Study Start: January 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: July 15, 2022

Record last verified: 2022-07

Locations

CN (1)