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CompletedNCT03802240Updated Nov 27, 2023

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

A Phase 3 interventional study of Sintilimab and IBI305 in Non-Squamous Non-Small Cell Lung Cancer, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-11-27.

Sponsored by Innovent Biologics (Suzhou) Co. Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
492
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Squamous Non-Small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 492 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 192 studies on the registry; 44 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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 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;
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
492 participants (actual)

Study arms

  • 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 · Drug: IBI305 · Drug: Pemetrexed · Drug: Cisplatin

  • 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 · Drug: Pemetrexed · Drug: Cisplatin · Drug: Placebo2

  • 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 · Drug: Cisplatin · Drug: Placebo1 · Drug: Placebo2

Interventions

  • DrugSintilimab

    200mg IV Q3W

    Also known as: IBI308

  • DrugIBI305

    15mg/kg IV Q3W

  • DrugPemetrexed

    500mg/m2 IV Q3W

  • DrugCisplatin

    75mg/m2 IV Q3W

  • DrugPlacebo1

    Placebo1 IV Q3W

  • DrugPlacebo2

    Placebo2 IV Q3W

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

07

Study locations

1 site
  • Shanghai Chest Hospital
    Shanghai, Shanghai 200030, China
08

References and documents

Publications

  • 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. doi: 10.1016/S1470-2045(22)00514-9. PubMed 35908558 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03802240
Lead sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Sponsor
First posted
Jan 14, 2019
Start date
Jul 11, 2019
Primary completion
Jul 31, 2021
Completion
Jun 30, 2023
Last update
Nov 27, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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