Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Randomized, Double-blind, Multi-center, Phase III Clinical Study Assessing the Efficacy and Safety of Sintilimab ± IBI305 Combined With Pemetrexed and Cisplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Failed Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment (ORIENT-31)
Actual Study Start Date :
July 12, 2019
Estimated Primary Completion Date :
May 31, 2021
Estimated Study Completion Date :
May 31, 2021
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Main Inclusion Criteria:
Signed written informed consent before any trial-related processes;
Age ≥ 18 years and <75 years male or females;
Has a histologically or cytologically confirmed stage IIIB/IIIC (American Joint Committee on Cancer [AJCC] 8th edition) NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC;
Patients with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatmen
EGFR-TKI resistance, confirmed by RECIST 1.1
The investigator confirms at least one measurable lesion according to RECIST 1.1. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if progression is confirmed;
The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
Squamous cell > 10%. If small cell types are present, the subject is not eligible for inclusion.;
Has previously received systemic anti-tumor treatment other than EGFR-TKI (including cytotoxic chemotherapy for radiotherapy, do not include other systemic treatment for other cured tumors);
Has previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or any other stimulatory or inhibitory agents of T cell receptors (eg CTLA-4, OX-40, CD137);
Has received EGFR-TKI treatment within 2 weeks;
Diagnosed of immunodeficiency or has received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drugs.
History of pneumonitis requiring steroid therapy or the presence of interstitial lung disease within 1 year prior to the first dose of study drugs;
Active central nervous system (CNS) metastasis and/or cancerous meningitis.
Hemoptysis within 3 months,
Full-dose oral or parenteral anticoagulant or thrombolytic agent for 10 consecutive days within 2 weeks. prophylactic use of anticoagulants is allowed;