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Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802240
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary:
The anti-tumor activity of anti-PD-1 therapy and VEGF inhibitor in TKI-resistant EGFR-mutated Chinese non-squamous NSCLC patients will be investigated in this clinical trial.

Condition or disease Intervention/treatment Phase
Non-Squamous Non-Small Cell Lung Cancer Drug: Sintilimab Drug: IBI305 Drug: Pemetrexed Drug: Cisplatin Drug: Placebo1 Drug: Placebo2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sintilimab +IBI305+Pemetrexed+Cisplatin Drug: Sintilimab
200mg IV Q3W
Other Name: IBI308

Drug: IBI305
15mg/kg IV Q3W

Drug: Pemetrexed
500mg/m2 IV Q3W

Drug: Cisplatin
75mg/m2 IV Q3W

Experimental: Sintilimab +Placebo2+Pemetrexed+Cisplatin Drug: Sintilimab
200mg IV Q3W
Other Name: IBI308

Drug: Pemetrexed
500mg/m2 IV Q3W

Drug: Cisplatin
75mg/m2 IV Q3W

Drug: Placebo2
Placebo2 IV Q3W

Active Comparator: Placebo1+Placebo2+Pemetrexed+Cisplatin Drug: Pemetrexed
500mg/m2 IV Q3W

Drug: Cisplatin
75mg/m2 IV Q3W

Drug: Placebo1
Placebo1 IV Q3W

Drug: Placebo2
Placebo2 IV Q3W




Primary Outcome Measures :
  1. PFS (Progression Free Survival) [ Time Frame: Time from the first dose of study drug to the first disease progression (imaging) through study completion, an average of 24 months. ]

Secondary Outcome Measures :
  1. OS (Overall Survival) [ Time Frame: Time from randomization to the death of the subject due to any cause assessed up to 36 months. ]
  2. ORR (overall response rate) [ Time Frame: The proportion of subjects who have a complete response (CR) or a partial response (PR) assessed up to 24 months. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  1. Signed written informed consent before any trial-related processes;
  2. Age ≥ 18 years and <75 years male or females;
  3. 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;
  4. Patients with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatmen
  5. EGFR-TKI resistance, confirmed by RECIST 1.1
  6. 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;
  7. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;

Exclusion criteria:

  1. Squamous cell > 10%. If small cell types are present, the subject is not eligible for inclusion.;
  2. 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);
  3. 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);
  4. Has received EGFR-TKI treatment within 2 weeks;
  5. 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.
  6. History of pneumonitis requiring steroid therapy or the presence of interstitial lung disease within 1 year prior to the first dose of study drugs;
  7. Active central nervous system (CNS) metastasis and/or cancerous meningitis.
  8. Hemoptysis within 3 months,
  9. Full-dose oral or parenteral anticoagulant or thrombolytic agent for 10 consecutive days within 2 weeks. prophylactic use of anticoagulants is allowed;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802240


Contacts
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Contact: tengfei zou +86 0512-69566088 tengfei.zou@innoventbio.com

Locations
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China
Shanghai Chest Hospital Recruiting
Shanghai, China
Contact: Shun Lu, M.D.,Ph.D    021-32260856    shun_lu@hotmail.com   
Sponsors and Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
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Responsible Party: Innovent Biologics (Suzhou) Co. Ltd.
ClinicalTrials.gov Identifier: NCT03802240    
Other Study ID Numbers: CIBI338A301
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors