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

NCT ID: NCT03830411

Last Updated: 2021-11-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-13
• Study Completion Date: 2022-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: Sintilimab

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.

Group Type: EXPERIMENTAL

Sintilimab

Intervention Type: DRUG

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

Arm B: Chemotherapy (Docetaxel or Pemetrexed)

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

Group Type: ACTIVE_COMPARATOR

Docetaxel

Intervention Type: DRUG

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

Pemetrexed

Intervention Type: DRUG

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

Interventions

Sintilimab

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

Intervention Type: DRUG

Docetaxel

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

Intervention Type: DRUG

Pemetrexed

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

Intervention Type: DRUG

Other Intervention Names

IBI308

Eligibility Criteria

Inclusion Criteria

1. Volunteer to participate in clinical research; fully understand and know the research and sign informed consent;

2. Age ≥ 18 years old and ≤ 75 years old, either sex;

3. Eastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;

4. 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;

5. Have at least one measurable lesion as defined by RECIST 1.1;

6. Has progression of disease after treatment with at least two cycles of a platinum-containing doublet chemotherapy according to RECIST V.1.1;

7. Patients without activating EGFR mutation;

8. 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;

9. Normal renal function: Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate );

10. 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];

11. Has a life expectancy of at ≥3 months.

Exclusion Criteria

1. ECOG PS >2;

2. Small cell lung cancer and squamous NSCLC;

3. EGFR mutation or mutation status unknown;

4. Known hypersensitivity or allergy to monoclonal antibody;

5. 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);

6. Active autoimmune disease, or a documented history of autoimmune disease;

7. Treatment with systemic corticosteroids (prednisone≥10mg per day or equivalent dose) or other systemic immunosuppressive medications within 2 weeks prior to the first dose;

8. Known history or active human immunodeficiency virus (HIV);

9. 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;

10. Interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment;

11. Active or poorly controlled severe infection;

12. 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;

13. Received thoracic radiation therapy of >30 Gy within 6 months prior to first dose of study drug;

14. Completed palliative radiotherapy within 7 days prior to first dose of study drug;

15. Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xin-Hua Xu

OTHER

Sponsor Role: lead

Responsible Party

Xin-Hua Xu

professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Yichang, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xinhua Xu, Master

Role: CONTACT

Phone: +8613986747496

Email: 2732774352@qq.com

Yan Wang, Master

Role: CONTACT

Phone: +8615997550081

Email: wangyan82033@163.com

Facility Contacts

Xinhua Xu

Role: primary

Other Identifiers

CTGU002

Identifier Type: -

Identifier Source: org_study_id