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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

Primary Purpose

Non-Squamous Non-Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Sintilimab
IBI305
Pemetrexed
Cisplatin
Placebo1
Placebo2
Sponsored by
Innovent Biologics (Suzhou) Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Squamous Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 treatment
  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; 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 for or advanced non-squamous NSCLC (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. Symptomatic central nervous system metastases (CNS) metastasis and/or cancerous meningitis.

    Hemoptysis within 3 months,

  8. Full-dose oral or parenteral anticoagulant or thrombolytic agent for 10 consecutive days within 2 weeks. prophylactic use of anticoagulants is allowed;

Sites / Locations

  • Shanghai Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Sintilimab +IBI305+Pemetrexed+Cisplatin

Sintilimab +Placebo2+Pemetrexed+Cisplatin

Placebo1+Placebo2+Pemetrexed+Cisplatin

Arm Description

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

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

Drug: Pemetrexed 500mg/m2 IV Q3W Drug: Cisplatin 75mg/m2 IV Q3W Drug: Placebo1 Placebo1 IV Q3W Drug: Placebo2 Placebo2 IV Q3W

Outcomes

Primary Outcome Measures

PFS (Progression Free Survival)

Secondary Outcome Measures

OS (Overall Survival)
ORR (overall response rate)
PFS (Progression Free Survival)
DCR(Disease control rate )
TTR(Time to objective response )
DOR(Duration of response)

Full Information

First Posted
January 7, 2019
Last Updated
September 22, 2022
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03802240
Brief Title
Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2019 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Innovent Biologics (Suzhou) Co. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Squamous Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sintilimab +IBI305+Pemetrexed+Cisplatin
Arm Type
Experimental
Arm Description
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
Arm Title
Sintilimab +Placebo2+Pemetrexed+Cisplatin
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo1+Placebo2+Pemetrexed+Cisplatin
Arm Type
Active Comparator
Arm Description
Drug: Pemetrexed 500mg/m2 IV Q3W Drug: Cisplatin 75mg/m2 IV Q3W Drug: Placebo1 Placebo1 IV Q3W Drug: Placebo2 Placebo2 IV Q3W
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Other Intervention Name(s)
IBI308
Intervention Description
200mg IV Q3W
Intervention Type
Drug
Intervention Name(s)
IBI305
Intervention Description
15mg/kg IV Q3W
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
500mg/m2 IV Q3W
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
75mg/m2 IV Q3W
Intervention Type
Drug
Intervention Name(s)
Placebo1
Intervention Description
Placebo1 IV Q3W
Intervention Type
Drug
Intervention Name(s)
Placebo2
Intervention Description
Placebo2 IV Q3W
Primary Outcome Measure Information:
Title
PFS (Progression Free Survival)
Time Frame
Time from randomization to first documented disease progression (radiographic) assessed by Independent Imaging Assessment Committee (IRRC) or death due to any cause. up to 24month
Secondary Outcome Measure Information:
Title
OS (Overall Survival)
Time Frame
Time from randomization to the death of the subject due to any cause assessed up to 36 months.
Title
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.
Title
PFS (Progression Free Survival)
Time Frame
Time from randomization to first documented disease progression (radiographic) assessed by investigator or death due to any cause up to 24 month.
Title
DCR(Disease control rate )
Time Frame
The proportion of subjects in the analysis population who had a complete response (CR) or partial response (PR) or stable disease (SD) up to 24 month.
Title
TTR(Time to objective response )
Time Frame
For subjects with CR or PR, defined as the time from randomization to the first documented CR or PR up to 24 month.
Title
DOR(Duration of response)
Time Frame
For subjects with CR or PR, defined as the time from the first documented CR or PR to disease progression or death up to 24 month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 treatment 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; Exclusion criteria: 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 for or advanced non-squamous NSCLC (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; Symptomatic central nervous system metastases (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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
tengfei zou
Phone
+86 0512-69566088
Email
tengfei.zou@innoventbio.com
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shun Lu, M.D.,Ph.D
Phone
021-32260856
Email
shun_lu@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
35908558
Citation
Lu S, Wu L, Jian H, Chen Y, Wang Q, Fang J, Wang Z, Hu Y, Sun M, Han L, Miao L, Ding C, Cui J, Li B, Pan Y, Li X, Ye F, Liu A, Wang K, Cang S, Zhou H, Sun X, Ferry D, Lin Y, Wang S, Zhang W, Zhang C. Sintilimab plus bevacizumab biosimilar IBI305 and chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): first interim results from a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2022 Sep;23(9):1167-1179. doi: 10.1016/S1470-2045(22)00382-5. Epub 2022 Jul 28. Erratum In: Lancet Oncol. 2022 Sep;23(9):e404.
Results Reference
derived

Learn more about this trial

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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