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

NCT04252365 | Unknown Phase 2

• 1 other identifier: CTONG1901
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Nsclc

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Defined as the percentage of patients whose tumors have a complete or partial response to treatment

  Up to 3 years

Study Arms (2)

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.

Drug: 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.

Drug: Pembrolizumab

Interventions

Sintilimab DRUG

Given i.v.

Also known as: IBI308

arm 1

Pembrolizumab DRUG

Given i.v.

Also known as: Keytruda

arm 2

Eligibility Criteria

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

You may qualify if:

• Age≥18 years. Signed Informed Consent Form.
• 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).
• Fresh tumor tissue or paraffin tissue within 6 months is adequate for PD-L1 expression (TPS) testing in the central laboratory.
• Tumor tissue without EGFR mutation or ALK rearrangement must be confirmed.
• 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.
• 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.

You may not qualify if:

• 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.
• Currently or prior clinically active interstitial lung disease. Currently active pneumonia. Current radiation pneumonitis for which corticosteroid treatment is required.
• Known HIV antibody positive, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
• Fever and the body temperature is above 38°C or clinically significant infection within 1 week prior to the enrollment.
• 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 \[CTCAE Grade 2 hypertension or above after drug treatment\]).
• Patients with active bleeding or new thrombotic diseases who are orally taking with anticoagulant drugs or have bleeding tendency.

Sponsors & Collaborators

• Guangdong Association of Clinical Trials: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sintilimab; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yi-Long Wu

  Guangdong Association of Clinical Trials, GACT

  STUDY CHAIR

Central Study Contacts

Yi-Long Wu

CONTACT

13809775415; syylwu@live.cn

Qing Zhou

CONTACT

13544561166; gzzhouqing@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: March 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 5, 2020

Record last verified: 2020-01