Sintilimab Versus Pembrolizumab for Advanced-stage Non-Small-Cell Lung Cancer

Nsclc Clinical Trial

Official title:

A Randomized Controlled, Phase II Trial Comparing Sintilimab and Pembrolizumab at First-line Setting in Patients With Advanced Non-small Cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04252365
• Other study ID #: CTONG1901
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: January 2020
• Source: Guangdong Association of Clinical Trials
• Contact: Yi-Long Wu
• Phone: 13809775415
• Email: syylwu[@]live.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a single-center, randomized controlled, phase II clinical trial, aiming at giving a comparison of Sintilimab and Pembrolizumab in stage IIIB-IV NSCLC patients at first-line treatment setting.

Description:

This trial has been set up with two arms. Screened patients would be included into one of the arms based on tumor PD-L1 expression. The purpose of this study is to compare the efficacy of the approved checkpoint inhibitor pembrolizumab and home-made drug Sintilimab in patients with advanced NSCLC whose tumor have high PD-L1 expression and low or negative expression.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age=18 years. Signed Informed Consent Form.

2. Stage IV NSCLC confirmed by histology/ cytology or Stage IIIB-IIIC NSCLC that could not be treated with radical radiation therapy (8th edition of IASLC Lung Cancer Staging System).

3. Fresh tumor tissue or paraffin tissue within 6 months is adequate for PD-L1 expression (TPS) testing in the central laboratory.

4. Tumor tissue without EGFR mutation or ALK rearrangement must be confirmed.

5. Per RECIST 1.1 the efficacy evaluation criteria for solid tumors, at least one radiologically measurable lesion which was not treated with radiotherapy or had obvious disease progression after radiotherapy.

6. Patients who received no systemic chemotherapy or any other systemic treatment for advanced NSCLC. For patients who received preoperative neoadjuvant chemotherapy or postoperative adjuvant chemotherapy or radical chemoradiotherapy, if the disease progresses occurred one six months after the last treatment, they can be enrolled. Patients who received targeted therapy or immunotherapy can not be enrolled.

Exclusion Criteria:

1. Active hepatitis B. Active hepatitis B is defined as HBsAg positive and the detected HBV-DNA copy number is larger than the upper limit of normal value in the laboratory of the study site.

2. Currently or prior clinically active interstitial lung disease. Currently active pneumonia. Current radiation pneumonitis for which corticosteroid treatment is required.

3. Known HIV antibody positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.

4. Fever and the body temperature is above 38°C or clinically significant infection within 1 week prior to the enrollment.

5. Active tuberculosis. Evidence of severe or uncontrollable systemic diseases (such as severe mental, neurological diseases, seizure, or dementia, unstable or non-compensatory respiratory, cardiovascular, hepatic or renal diseases, and uncontrolled hypertension [CTCAE Grade 2 hypertension or above after drug treatment]).

6. Patients with active bleeding or new thrombotic diseases who are orally taking with anticoagulant drugs or have bleeding tendency.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Nsclc

Intervention

Drug:
• Sintilimab
Given i.v.
• Pembrolizumab
Given i.v.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Association of Clinical Trials

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	Defined as the percentage of patients whose tumors have a complete or partial response to treatment	Up to 3 years