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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

NCT ID: NCT03802240

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

492 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-11

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Squamous Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Sintilimab

Intervention Type DRUG

200mg IV Q3W

IBI305

Intervention Type DRUG

15mg/kg IV Q3W

Pemetrexed

Intervention Type DRUG

500mg/m2 IV Q3W

Cisplatin

Intervention Type DRUG

75mg/m2 IV Q3W

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

Group Type EXPERIMENTAL

Sintilimab

Intervention Type DRUG

200mg IV Q3W

Pemetrexed

Intervention Type DRUG

500mg/m2 IV Q3W

Cisplatin

Intervention Type DRUG

75mg/m2 IV Q3W

Placebo2

Intervention Type DRUG

Placebo2 IV Q3W

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

Group Type ACTIVE_COMPARATOR

Pemetrexed

Intervention Type DRUG

500mg/m2 IV Q3W

Cisplatin

Intervention Type DRUG

75mg/m2 IV Q3W

Placebo1

Intervention Type DRUG

Placebo1 IV Q3W

Placebo2

Intervention Type DRUG

Placebo2 IV Q3W

Interventions

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Sintilimab

200mg IV Q3W

Intervention Type DRUG

IBI305

15mg/kg IV Q3W

Intervention Type DRUG

Pemetrexed

500mg/m2 IV Q3W

Intervention Type DRUG

Cisplatin

75mg/m2 IV Q3W

Intervention Type DRUG

Placebo1

Placebo1 IV Q3W

Intervention Type DRUG

Placebo2

Placebo2 IV Q3W

Intervention Type DRUG

Other Intervention Names

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IBI308

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Lu S, Wu L, Jian H, Cheng Y, Wang Q, Fang J, Wang Z, Hu Y, Han L, Sun M, Miao L, Ding C, Cui J, Wang K, Li B, Li X, Ye F, Liu A, Pan Y, Cang S, Zhou H, Sun X, Shen Y, Wang S, Zhang W, He Y. Sintilimab plus chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer with disease progression after EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): second interim analysis from a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2023 Jul;11(7):624-636. doi: 10.1016/S2213-2600(23)00135-2. Epub 2023 May 5.

Reference Type DERIVED
PMID: 37156249 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35908558 (View on PubMed)

Other Identifiers

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CIBI338A301

Identifier Type: -

Identifier Source: org_study_id