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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

Sponsor
Innovent Biologics (Suzhou) Co. Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03802240
Collaborator
(none)
600
Enrollment
1
Location
3
Arms
57.7
Anticipated Duration (Months)
10.4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Jul 11, 2019
Actual Primary Completion Date :
Jul 31, 2021
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

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

Drug: Sintilimab
200mg IV Q3W
Other Names:
  • 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

    Drug: Sintilimab
    200mg IV Q3W
    Other Names:
  • 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

    Drug: Pemetrexed
    500mg/m2 IV Q3W

    Drug: Cisplatin
    75mg/m2 IV Q3W

    Drug: Placebo1
    Placebo1 IV Q3W

    Drug: Placebo2
    Placebo2 IV Q3W

    Outcome Measures

    Primary Outcome Measures

    1. PFS (Progression Free Survival) [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 Measures

    1. OS (Overall Survival) [Time from randomization to the death of the subject due to any cause assessed up to 36 months.]

    2. ORR (overall response rate) [The proportion of subjects who have a complete response (CR) or a partial response (PR) assessed up to 24 months.]

    3. PFS (Progression Free Survival) [Time from randomization to first documented disease progression (radiographic) assessed by investigator or death due to any cause up to 24 month.]

    4. DCR(Disease control rate ) [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.]

    5. TTR（Time to objective response ) [For subjects with CR or PR, defined as the time from randomization to the first documented CR or PR up to 24 month.]

    6. DOR(Duration of response) [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.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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,

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Chest Hospital Shanghai Shanghai China 200030

    Sponsors and Collaborators

    • Innovent Biologics (Suzhou) Co. Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Innovent Biologics (Suzhou) Co. Ltd.
    ClinicalTrials.gov Identifier:
    NCT03802240
    Other Study ID Numbers:
    • CIBI338A301
    First Posted:
    Jan 14, 2019
    Last Update Posted:
    Feb 2, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Pemetrexed

    Study Results

    No Results Posted as of Feb 2, 2022