A Phase II Study of Anti-PD-1 Antibody, Sintilimab, as Second-line Therapy for Biomarker-selected Advanced or Metastatic NSCLC

NCT04612673 | Unknown Phase 2

• 1 other identifier: CIBI308Y035
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to to explore the efficacy and safety of PD-1 immune check point inhibitor, sintilimab, in biomarker-selected subjects with advanced or metastatic Non-small Cell Lung Cancer who have failed from standard front-line treatment.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progress free survival (PFS)

  PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.

  untill Progressive Disease(PD) or death(up to 24 months)

Secondary Outcomes (3)

• Overall Survival (OS)

  From randomization until death (up to 24 months)

• Objective Response Rate (ORR)

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

• Disease Control Rate (DCR)

  each 42 days up to intolerance the toxicity or PD (up to 24 months)

Study Arms (1)

Treatment

EXPERIMENTAL

Participants received Sintilimab, 200mg, iv, d1, Q3W,and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent

Drug: Sintilimab

Interventions

Sintilimab DRUG

immune checkpoint inhibitor, 200mg, iv, d1,Q3W

Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 and ≤ 70 years of age , regardless of gender；
• Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC (according to the eighth edition of AJCC staging, IIIB, IIIC, IV), with at least one measurable lesion (RECIST 1.1)
• treatment failure after first-line standard treatment (definition of treatment failure: intolerable side effects, disease progression during or after treatment);
• No known EGFR sensitive mutations and ALK gene rearrangements.
• Tumor tissue samples that meet the testing requirements for biomarker testing can be provided. Testing will be carried out in the central laboratory.
• NSCLC that is anti-programmed cell death ligand 1 (PD-L1) positive(TPS PD-L1 expression is ≥1% ), and CD8 expression is ≥20% (pre-treatment samples are sufficient).
• ECOG PS: 0-1
• Sufficient organ and bone marrow function as defined below:
• Routine blood examination:
• HB≥90g/L;
• ANC ≥1.5×109/L;
• PLT ≥90×109/L;
• Biochemical inspection shall:
• Total bilirubin ≤ 1.5 ULN;
• ALT and AST≤2.5ULN;

You may not qualify if:

• Allergic to any ingredients of Sintilimab preparations; or have had severe allergic reactions to other monoclonal antibodies in the past.
• Received more than one regimen for the treatment of locally advanced or metastatic NSCLC in the past (except for adjuvant/neoadjuvant chemotherapy that has exceeded the 24-week).
• Received any anti-PD-1/PD-L1 antibody, anti-CTLA4 antibody, or other immunotherapy in the past.
• Diagnosed other malignant tumors within 5 years before the first administration, excluding radically cured skin basal cell carcinoma, skin squamous cell carcinoma and/or radically excised carcinoma in situ.
• Be treated with anti-tumor vaccines or other immunostimulatory anti-tumor drugs (interferon, interleukin, thymosin, immune cell therapy, etc.) within 1 month before enrolled.
• Central nervous system metastasis with symptoms..
• Acute or chronic active hepatitis B (defined as positive for hepatitis B virus surface antigen HBsAg during the screening period) or hepatitis C infection.
• History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function and other lung diseases.
• Active tuberculosis (TB), who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before the first administration.
• People infected with human immunodeficiency virus (HIV) (HIV antibody positive), people with known syphilis infection.
• Patients who are considered to be at greater medical risk due to severe, uncontrollable diseases, non-metastatic systemic diseases, or active, uncontrollable infections.
• An active autoimmune disease that requires systemic treatment (such as the use
• disease-relieving drugs, corticosteroids, or immunosuppressive agents) occurred within 2 years before the first administration.
• Have used immunosuppressive drugs within 4 weeks before the first administration, excluding nasal spray, inhaled or other local glucocorticoids or physiological doses of systemic glucocorticoids (ie not more than 10 mg/day prednisone Loose or equivalent doses of other glucocorticoids), allowing temporary use of glucocorticoids for the treatment of asthma, chronic obstructive pulmonary disease and other diseases such as dyspnea symptoms.
• Exclude subjects who are expected to require any other form of anti-tumor therapy (including maintenance therapy with other NSCLC drugs, radiotherapy, and/or surgical resection) in the study.

Sponsors & Collaborators

• China Medical University, China: lead
• Shengjing Hospital: collaborator
• The First People's Hospital of Jingzhou: collaborator
• The People's Hospital of Liaoning Province: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• Anshan Tumor Hospital: collaborator
• Benxi Cental Hospital: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator

Study Sites (1)

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sintilimab

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

• Yunpeng Liu, PhD

  China Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuo Wang, PhD

CONTACT

0086-024-83281806; suresure_wang@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Medical Oncology

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 3, 2020
• Study Start: November 20, 2020
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: November 3, 2020

Record last verified: 2020-10

Locations

CN (1)