A Study to Evaluate SHR-1210 in Patients With Advanced or Metastatic NSCLC

NCT03085069 | Unknown Phase 2

• 1 other identifier: SHR-1210-II-201-NSCLC
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, single-arm, multi-center, phase 2 Study to evaluate SHR-1210(anti-PD-1 antibody) in in adult Chinese patients with advanced or metastatic non-small cell lung cancer who failed or progressed to prior first-line systemic treatment. Enrolled subjects will be assigned to 4 cohorts on the basis of PD-L1 expression in tumor cells(\<1%, ≥1%-25%, ≥25%-50%, ≥50%) all will be treated with the standard SHR-1210 dose (200mg) , Q2W, until documented progressive disease (PD) occurs. Subjects will return to the clinic once every two weeks. Radiographic disease assessments will be performed every 6 weeks. The primary study hypothesis is that treatment with SHR-1210 improves Objective Response Rate when compare with standard second-line therapy, no matter how much PD-L1 expression in tumor.

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms Nec; Lung Disease; Respiratory Tract Disease; Neoplasm, Bronchial; Carcinoma, Bronchogenic

Keywords

PD-1; PD-L1; SHR-1210

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Objective response is defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment.

  Determined using RECIST v1.1 criteria, up to approximately 1 year

Secondary Outcomes (4)

• Duration of Response Rate

  Determined using RECIST v1.1 criteria, up to approximately 1 year

• Overall Survival Rate at 12-month

  up to approximately 1 year

• Progression-Free Survival

  Determined using RECIST v1.1 criteria, up to approximately 1 year

• Number of participants with treatment-related adverse events (AEs)

  up to approximately 1 year

Study Arms (4)

PD-L1 expression in tumor ≥ 50%

EXPERIMENTAL

Subjects receive SHR-1210 intravenous at the dose 200mg on Day 1 every 2 weeks

Biological: SHR-1210

PD-L1 expression in tumor ≥25-50%

EXPERIMENTAL

Subjects receive SHR-1210 intravenous at the dose 200mg on Day 1 every 2 weeks

Biological: SHR-1210

PD-L1 expression in tumor ≥ 1-25%

EXPERIMENTAL

Subjects receive SHR-1210 intravenous at the dose 200mg on Day 1 every 2 weeks

Biological: SHR-1210

PD-L1 expression in tumor < 1%

EXPERIMENTAL

Subjects receive SHR-1210 intravenous at the dose 200mg on Day 1 every 2 weeks

Biological: SHR-1210

Interventions

SHR-1210 BIOLOGICAL

SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody

PD-L1 expression in tumor < 1%; PD-L1 expression in tumor ≥ 1-25%; PD-L1 expression in tumor ≥ 50%; PD-L1 expression in tumor ≥25-50%

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with histologically- or cytologically- documented NSCLC who present with Stage IIIB-IV disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology), or disease recurrence or progression following multi-modal therapy (radiation therapy, surgical resection or radical chemo-radiotherapy in locally advanced disease).
• Fresh cutting specimens or hollow needle aspiration specimens must be provided. A formalin fixed, paraffin-embedded (FFPE) tumor tissue block or unstained slides of tumor sample (must be recent) must be available for biomarker evaluation. In the case of unstained slides, a minimum of 8 slides are necessary to conduct the planned biomarker analyses. Specimens must be received by the central lab prior to randomization. Biopsy should be excisional, incisional or core needle.
• Subjects must have experienced disease recurrence or progression during or after one prior platinum-containing doublet chemotherapy regimen for advanced or metastatic disease:
• Subjects who received maintenance therapy (non-progressors with platinum-based doublet chemotherapy) and progressed are eligible.
• Subjects who received adjuvant or neoadjuvant platinum-doublet chemotherapy (after surgery and/or radiation therapy) and developed recurrent or metastatic disease within 6 months of completing therapy are eligible.
• Subjects with recurrent disease \> 6 months after adjuvant or neoadjuvant platinum based chemotherapy, who also subsequently progressed during or after a platinum-doublet regimen given to treat the recurrence, are eligible.
• Subjects with sensitizing EGFR mutation positive or ALK rearrangement positive, must have experienced disease recurrence or progression during or after one prior tyrosine kinase inhibitor regimen, who also have PD-L1 expression in tumor ≥ 50%, are eligible.
• Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria; Radiographic Tumor Assessment performed within 28 days of randomization.
• Eastern Cooperative Oncology Arm (ECOG) performance status of ≤ 1.
• All baseline laboratory requirements will be assessed and should be obtained within -14 days of randomization. Screening laboratory values must meet the following criteria.
• Absolute neutrophil count ≥ 1.5 × 109/L (1500/mm3)
• Platelets ≥ 80× 109/L (100,000/mm3)
• Hemoglobin ≥ 9.0 g/dL (90 g/L)
• Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN); for subjects with liver metastases, ALT and AST ≤ 5 × ULN

You may not qualify if:

• Target Disease Exceptions
• Subjects with active CNS metastases are excluded. Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).
• Subjects with carcinomatous meningitis.
• Medical History and Concurrent Diseases
• Subjects with active, known or suspected autoimmune disease. Subjects in conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• Prior therapy with immunostimulatory medications or tumor vaccines within 6 months.
• Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody (including any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
• Treatment with any investigational agent within 5 half-life of the agent, before the first administration of study treatment.
• Subjects with a history of interstitial lung disease.
• Subjects received lung radiation therapy within 6 months.
• Other active malignancy requiring concurrent intervention.
• Subjects with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, endometrial, cervical/dysplasia) are excluded unless a complete remission was achieved at least 5 years prior to study entry.
• Subjects have had prior chemotherapy within 3 weeks prior to study, or have had prior targeted small molecule therapy within 1 weeks prior to study, or have had prior radiation therapy or surgical operation within 4 weeks prior to study, or have had prior anti-tumor biotherapy within 3 weeks prior to study. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must have resolved to grade 1 (NCI CTCAE version 4) or baseline before administration of study drug.
• Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of study treatment

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Guangdong Lung Cancer Institute (GLCI),Guangdong General Hospital (GGH)

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• Yang JJ, Huang C, Fan Y, Pan H, Feng J, Jiang L, Li XY, Liu XQ, Xiong JP, Zhao YQ, Cheng Y, Ma R, Wang J, Wang Y, Liu YH, Lin DM, Wang T, Shi W, Zou J, Wu YL. Camrelizumab in different PD-L1 expression cohorts of pre-treated advanced or metastatic non-small cell lung cancer: a phase II study. Cancer Immunol Immunother. 2022 Jun;71(6):1393-1402. doi: 10.1007/s00262-021-03091-3. Epub 2021 Oct 20.

  PMID: 34668977 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Lung Diseases; Respiratory Tract Diseases; Bronchial Neoplasms; Carcinoma, Bronchogenic

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Bronchial Diseases

Study Officials

• Wei Shi, MD

  Jiangsu Hengrui Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 21, 2017
• Study Start: May 3, 2017
• Primary Completion: August 20, 2020
• Study Completion: August 20, 2023
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

CN (1)