A Study of Sintilimab Compared With Docetaxel or Pemetrexed as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer After Failure With Platinum-Containing Chemotherapy

NCT03830411 | Unknown Phase 2 DMC

• 1 other identifier: CTGU002
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab compared with docetaxel or pemetrexed 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

Keywords

Sintilimab; docetaxel; pemetrexed; nonsquamous non-small-cell lung cancer; wild-type EGFR; second-line treatment

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  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 21 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Approximately 21 months

• Progression-free survival (PFS)

  Approximately 21 months

• Duration of response (DOR)

  Approximately 21 months

• Emergence of adverse events(AEs)

  Approximately 21 months

Study Arms (2)

Arm A: Sintilimab

EXPERIMENTAL

Participants will receive Sintilimab as long as they continue to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.

Drug: Sintilimab

Arm B: Chemotherapy (Docetaxel or Pemetrexed)

ACTIVE COMPARATOR

Participants randomized to the chemotherapy arm will receive docetaxel or pemetrexed until disease progression per standard RECIST v1.1 or unacceptable toxicity.

Drug: Docetaxel; Drug: Pemetrexed

Interventions

Sintilimab DRUG

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

Also known as: IBI308

Arm A: Sintilimab

Docetaxel DRUG

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

Arm B: Chemotherapy (Docetaxel or Pemetrexed)

Pemetrexed DRUG

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

Arm B: Chemotherapy (Docetaxel or Pemetrexed)

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: February 2, 2019
• First Posted: February 5, 2019
• Study Start: March 13, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: November 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)