Status:
COMPLETED
Sintilimab ± IBI305 Plus Chemotherapy (Pemetrexed + Cisplatin) for EGFRm + Locally Advanced or Metastasis Non-Squamous NSCLC Patients After EGFR-TKI Treatment Failure
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Non-Squamous Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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;
Exclusion
Key Trial Info
Start Date :
July 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
492 Patients enrolled
Trial Details
Trial ID
NCT03802240
Start Date
July 11 2019
End Date
June 30 2023
Last Update
November 27 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030