Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure
- Conditions
- Non-Squamous Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT03802240
- Lead Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 492
- 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:
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Squamous cell > 10%. If small cell types are present, the subject is not eligible for inclusion.;
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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);
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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);
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Has received EGFR-TKI treatment within 2 weeks;
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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.
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History of pneumonitis requiring steroid therapy or the presence of interstitial lung disease within 1 year prior to the first dose of study drugs;
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Symptomatic central nervous system metastases (CNS) metastasis and/or cancerous meningitis.
Hemoptysis within 3 months,
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Full-dose oral or parenteral anticoagulant or thrombolytic agent for 10 consecutive days within 2 weeks. prophylactic use of anticoagulants is allowed;
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sintilimab +IBI305+Pemetrexed+Cisplatin 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 Sintilimab +Placebo2+Pemetrexed+Cisplatin Sintilimab 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 Placebo1+Placebo2+Pemetrexed+Cisplatin Cisplatin Drug: Pemetrexed 500mg/m2 IV Q3W Drug: Cisplatin 75mg/m2 IV Q3W Drug: Placebo1 Placebo1 IV Q3W Drug: Placebo2 Placebo2 IV Q3W Sintilimab +IBI305+Pemetrexed+Cisplatin IBI305 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 Sintilimab +Placebo2+Pemetrexed+Cisplatin Placebo2 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 Placebo1+Placebo2+Pemetrexed+Cisplatin Placebo1 Drug: Pemetrexed 500mg/m2 IV Q3W Drug: Cisplatin 75mg/m2 IV Q3W Drug: Placebo1 Placebo1 IV Q3W Drug: Placebo2 Placebo2 IV Q3W Placebo1+Placebo2+Pemetrexed+Cisplatin Placebo2 Drug: Pemetrexed 500mg/m2 IV Q3W Drug: Cisplatin 75mg/m2 IV Q3W Drug: Placebo1 Placebo1 IV Q3W Drug: Placebo2 Placebo2 IV Q3W Sintilimab +IBI305+Pemetrexed+Cisplatin Sintilimab 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 Sintilimab +IBI305+Pemetrexed+Cisplatin Pemetrexed 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 Sintilimab +Placebo2+Pemetrexed+Cisplatin Pemetrexed 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 Placebo1+Placebo2+Pemetrexed+Cisplatin Pemetrexed Drug: Pemetrexed 500mg/m2 IV Q3W Drug: Cisplatin 75mg/m2 IV Q3W Drug: Placebo1 Placebo1 IV Q3W Drug: Placebo2 Placebo2 IV Q3W Sintilimab +Placebo2+Pemetrexed+Cisplatin 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
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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. OS (Overall Survival) Time from randomization to the death of the subject due to any cause assessed up to 36 months. ORR (overall response rate) The proportion of subjects who have a complete response (CR) or a partial response (PR) assessed up to 24 months. 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. 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. 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.
Trial Locations
- Locations (1)
Shanghai Chest Hospital
🇨🇳Shanghai, Shanghai, China