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

January 31, 2020 updated by: Guangdong Association of Clinical Trials

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

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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yi-Long Wu
  • Phone Number: +86 13809775415
  • Email: syylwu@live.cn

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: arm 1

Patients with PD-L1 high expression (TPS≥50%) receive Sintilimab injection 200mg i.v. on day 1 every three weeks (Q3W). Courses repeat every 21days in the absence of disease progression or unacceptable toxicity.

Patients with PD-L1 low or negative expression (TPS<50%) receive Sintilimab injection 200mg i.v. in combination with platinum-based chemotherapy every three weeks (Q3W) for 4 cycles. After that, patients receive Sintilimab injection on day 1 Q3W during the maintenance phase (Cycle 5 onward). Courses repeat every 21days in the absence of disease progression or unacceptable toxicity.

Given i.v.
Other Names:
  • IBI308
ACTIVE_COMPARATOR: arm 2

Patients with PD-L1 high expression (TPS≥50%) receive Pembrolizumab injection 200mg i.v. on day 1once every three weeks (Q3W). Courses repeat every 21days in the absence of disease progression or unacceptable toxicity.

Patients with PD-L1 low or negative expression (TPS<50%) receive Pembrolizumab injection 200mg i.v. in combination with platinum-based chemotherapy every three weeks (Q3W) for 4 cycles. After that, patients receive Pembrolizumab injection on day 1 Q3W during the maintenance phase (Cycle 5 onward). Courses repeat every 21days in the absence of disease progression or unacceptable toxicity.

Given i.v.
Other Names:
  • Keytruda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: Up to 3 years
Defined as the percentage of patients whose tumors have a complete or partial response to treatment
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Yi-Long Wu, Guangdong Association of Clinical Trials, GACT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2020

Primary Completion (ANTICIPATED)

March 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

January 31, 2020

First Submitted That Met QC Criteria

January 31, 2020

First Posted (ACTUAL)

February 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

January 31, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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