Last updated: November 23, 2023
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Overall Status: Completed
Phase
3
Condition
N/ATreatment
Cisplatin
Placebo2
Pemetrexed
Clinical Study ID
NCT03802240
CIBI338A301
Ages 18-75 All Genders
Study Summary
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 JointCommittee on Cancer [AJCC] 8th edition) NSCLC that is unresectable and not fit forradical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC;
- Patients with EGFR mutation confirmed by tumor histology or cytology or hematologyprior 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. Ameasurable lesion located in the field of previous radiation therapy or after localtreatment may be selected as a target lesion if progression is confirmed; The EasternCancer Cooperative Group (ECOG) performance score of 0 or 1;
Exclusion
Exclusion criteria:
- Squamous cell > 10%. If small cell types are present, the subject is not eligible forinclusion.;
- Has previously received systemic anti-tumor treatment other than EGFR-TKI for oradvanced non-squamous NSCLC (including cytotoxic chemotherapy for radiotherapy, do notinclude other systemic treatment for other cured tumors);
- Has previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2drugs 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 otherform of immunosuppressive therapy within 7 days prior to the first dose of studydrugs.
- History of pneumonitis requiring steroid therapy or the presence of interstitial lungdisease within 1 year prior to the first dose of study drugs;
- Symptomatic central nervous system metastases (CNS) metastasis and/or cancerousmeningitis. Hemoptysis within 3 months,
- Full-dose oral or parenteral anticoagulant or thrombolytic agent for 10 consecutivedays within 2 weeks. prophylactic use of anticoagulants is allowed;
Study Design
Total Participants: 492
Treatment Group(s): 6
Primary Treatment: Cisplatin
Phase: 3
Study Start date:
July 11, 2019
Estimated Completion Date:
June 30, 2023
Connect with a study center
Shanghai Chest Hospital
Shanghai, Shanghai 200030
ChinaSite Not Available

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