Clinical Trial: NCT04252365 - My Cancer Genome

NCT04252365

Description:

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.

Related Conditions:

Non-Small Cell Lung Carcinoma

Recruiting Status:

Not yet recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT04252365

Trial Eligibility

Document

Title

Brief Title: Sintilimab Versus Pembrolizumab for Advanced-stage Non-Small-Cell Lung Cancer
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 IDs

ORG STUDY ID: CTONG1901
NCT ID: NCT04252365

Conditions

Nsclc

Interventions

Drug	Synonyms	Arms
Sintilimab	IBI308	arm 1
Pembrolizumab	Keytruda	arm 2

Purpose

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.

Trial Arms

Name	Type	Description	Interventions
arm 1	Experimental	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.	Sintilimab
arm 2	Active Comparator	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.	Pembrolizumab

Eligibility Criteria

        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.

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

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

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Not yet recruiting
Lead Sponsor:	Guangdong Association of Clinical Trials

Trial Keywords

PD-1 inhibitors, immunotherapy, NSCLC, PD-L!

Last Updated

February 5, 2020

Clinical Trials /

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