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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05460195
Other study ID # ChestKS22002
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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