Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC) MedDRA version: 20.0 Level: LLT Classification code 10079440 Term: Non-squamous non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: BCD-100
Product Code: BCD-100
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PROLGOLIMAB
CAS Number: 2093956-19-3
Current Sponsor code: N/A
Other descrip
Sponsors
JSC BIOCAD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 3. Previously untreated subjects with histologically-confirmed stage IV (M1a/M1b/M1c- AJCC 8th edition) non-squamous NSCLC; 5. The time from the completion of previous adjuvant/neoadjuvant treatment to metastatic disease development is no less than 12 months 6. Has a life expectancy of at least 12 weeks; 7. Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; 9. Agreement to newly obtained core or excisional biopsy of a tumor lesion not previously irradiated for determination of PD-L1 status prior to randomization (if obtaining of new sample is contraindicated or puts subject at unacceptable risks, then fresh archival tumor tissue sample must be available) 10. Measurable disease according to CT/MRI scan (RECIST 1.1 criteria), confirmed by the local assessment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 190 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 918
Exclusion criteria
Exclusion criteria: 1. Has predominantly squamous cell histology NSCLC; Mixed tumours will be categorized by the predominant cell type; if small cell elements are present, the subject is ineligible. 2. Presence of EGFR mutation or ALK rearrangement; 3. Has received prior systemic cytotoxic chemotherapy/chemoradiotherapy for metastatic disease; 4. Has received antineoplastic therapy with targeted or immunotherapeutic drugs (including but not limited to EGFR inhibitors [e.g., erlotinib, gefitinib, cetuximab], ALK inhibitors, PD-1/PD-L1/PD-L2/CTLA4, VEGF/VEGFR inhibitors) or it is expected to require any other form of antineoplastic therapy while on study; 11. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; 12. Active or known or suspected autoimmune disease (subjects with Type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, or skin disorders (vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and compare efficacy of BCD-100 in combination with pemetrexed+cisplatin/carboplatin and Placebo in combination with pemetrexed+cisplatin/carboplatin as first-line treatment in subjects with metastatic NSCLC using OS;Secondary Objective: • To evaluate and compare efficacy of BCD-100 in combination with pemetrexed+cisplatin/carboplatin and Placebo in combination with pemetrexed+cisplatin/carboplatin as first-line treatment in subjects with metastatic NSCLC using ORR and PFS per RECIST 1.1 as assesses by BICR; • To evaluate efficacy of BCD-100 in combination with pemetrexed+cisplatin/carboplatin versus Placebo in combination with pemetrexed+cisplatin/carboplatin according to PD-L1 expression status using OS, PFS, ORR, DCR • To evaluate and compare the safety of BCD-100 in combination with pemetrexed+cisplatin/carboplatin and Placebo in combination with pemetrexed+cisplatin/carboplatin as first-line treatment in subjects with metastatic NSCLC ;Primary end point(s): overall survival (OS) - the time from the date of randomization until death due to any cause;Timepoint(s) of evaluation of this end point: OS will be assessed according to the data obtained at regular visits and during the follow-up by phone up to 3 years from the start of the therapy or until the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • progression-free survival (PFS) per RECIST 1.1 criteria assessed by BICR - the time from the date of randomization until progression of disease according to RECIST 1.1 criteria or death, • overall response rate (ORR) per RECIST 1.1 criteria assessed by BICR, • disease control rate (DCR) per RECIST 1.1 criteria assessed by BICR, • time to response (TTR), • duration of response (DOR) ;Timepoint(s) of evaluation of this end point: PFS, ORR, DCR, TTR, DOR will be assessed based on results of CT/MRI according to RECIST 1.1 criteria by blinded independent central review (BICR). Additional assessment of PFS and ORR will be performed according to iRECIST criteria. Contrast-enhanced CT/MRI will be performed on weeks 7, 13, 19, 25, 31, 40, 49, 61, 73, 97, 121, 145, additional CT/MRI scans can be performed within unscheduled visits. | — |
Countries
China, Czechia, Hungary, Romania, Russian Federation, Slovakia
Contacts
Public ContactClinical Trials Department
JSC BIOCAD
Outcome results
None listed