A Study of Sintilimab or Placebo in Combination With Chemotherapy as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer With Wild-type EGFR After Failure With Platinum-Containing Chemotherapy.

NCT03863483 | Unknown Phase 2

• 1 other identifier: CTGU003
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab or placebo in combination with chemotherapy as second-line treatment for patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Treatment may continue as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

Conditions

Nonsquamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Compare Overall Survival (OS) between sintilimab +chemotherapy and placebo + chemotherapy.

  To compare the efficacy of the combination of sintilimab and chemotherapy versus placebo and chemotherapy in terms of overall survival (OS) in patients with stage IV nonsquamous non-small cell lung cancer with wild-type EGFR after failure with platinum-containing chemotherapy. Overall Survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. Data for participants who were not reported as dead at the time of analysis was censored at the date when they were last known to be alive.

  approximately 24 months

Secondary Outcomes (4)

• Compare objective response rate between sintilimab +chemotherapy and placebo + chemotherapy.

  approximately 24 months

• Compare Progression Free Survival (PFS) between sintilimab +chemotherapy and placebo + chemotherapy using RECIST 1.1.

  approximately 24 months

• Compare duration of response between sintilimab +chemotherapy and placebo + chemotherapy.

  approximately 24 months

• Number of Participants who Experience Treatment Related Adverse Events (AEs).

  approximately 24 months

Study Arms (2)

Sintilimab plus chemotherapy

EXPERIMENTAL

Sintilimab (200 mg) plus chemotherapy (physicians' choice between docetaxel and pemetrexed) every 3 weeks.

Drug: Sintilimab; Drug: Docetaxel; Drug: Pemetrexed

Placebo plus chemotherapy

ACTIVE COMPARATOR

Placebo plus chemotherapy (physicians' choice between docetaxel and pemetrexed) every 3 weeks.

Drug: Docetaxel; Drug: Pemetrexed; Drug: Placebo

Interventions

Sintilimab DRUG

Sintilimab will be administered intravenously at a fixed dose of 200 milligrams (mg) on Day 1 of each 21-day cycle.

Sintilimab plus chemotherapy

Docetaxel DRUG

Docetaxel 75 milligrams per square meter (mg/m\^2) will be administered intravenously on Day 1 of each 21-day cycle.

Placebo plus chemotherapy; Sintilimab plus chemotherapy

Pemetrexed DRUG

Pemetrexed 500 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.

Placebo plus chemotherapy; Sintilimab plus chemotherapy

Placebo DRUG

0.9% sodium chloride injection as placebo will be administered intravenously at a fixed dose of 100 milliliters (mL) on Day 1 of each 21-day cycle.

Placebo plus chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteer to participate in clinical research; fully understand and know the research and sign informed consent;
• Age ≥ 18 years old and ≤ 75 years old, either sex;
• Eastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;
• Has a histologically or cytologically confirmed diagnosis of stage IV (according to the 8th edition of the International Association for the Study of Lung Cancer) nonsquamous NSCLC;
• Have at least one measurable lesion as defined by RECIST 1.1;
• Has progression of disease after treatment with at least two cycles of a platinum-containing doublet chemotherapy according to RECIST V.1.1;
• Patients without activating EGFR mutation;
• Normal hepatic function: total bilirubin≤1.5×normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ≤2.5×ULN or ≤5×ULN if liver metastasis is present;
• Normal renal function: Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate );
• Normal hematological function: absolute neutrophil count ≥1.5×109/L, platelet count ≥70×109/L, hemoglobin≥80g/L \[no blood transfusion or erythropoietin (EPO) within 7 days\] Dependency\];
• Has a life expectancy of at ≥3 months.

You may not qualify if:

• ECOG PS \>2;
• Small cell lung cancer and squamous NSCLC;
• EGFR mutation or mutation status unknown;
• Known hypersensitivity or allergy to monoclonal antibody;
• Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways);
• Active autoimmune disease, or a documented history of autoimmune disease;
• Treatment with systemic corticosteroids (prednisone≥10mg per day or equivalent dose) or other systemic immunosuppressive medications within 2 weeks prior to the first dose;
• Known history or active human immunodeficiency virus (HIV);
• Known acute or chronic active hepatitis B (HBV DNA positive) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection;
• Interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment;
• Active or poorly controlled severe infection;
• Have serious cardiovascular disease: Symptomatic congestive heart failure (New York Heart Association grade III-IV), unstable angina pectoris, unstable arrhythmia, myocardial infarction or cerebrovascular accident within 3 months before randomization;
• Received thoracic radiation therapy of \>30 Gy within 6 months prior to first dose of study drug;
• Completed palliative radiotherapy within 7 days prior to first dose of study drug;
• Pregnant or lactating women.

Sponsors & Collaborators

• Xin-Hua Xu: lead

Study Sites (1)

Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University

Yichang, Hubei, 443003, China

RECRUITING

MeSH Terms

Interventions

sintilimab; Docetaxel; Pemetrexed

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Central Study Contacts

Xinhua Xu, Master

CONTACT

+8613986747496; 2732774352@qq.com

Yan Wang, Master

CONTACT

+8615997550081; wangyan82033@163.com

Study Design

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

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 5, 2019
• Study Start: March 26, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: November 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)