E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC) |
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E.1.1.1 | Medical condition in easily understood language |
lung cancer on late stages |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10079440 |
E.1.2 | Term | Non-squamous non-small cell lung cancer |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
• 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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 scan/ MRI (RECIST 1.1 criteria), confirmed by the local assessment
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E.4 | Principal 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).
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E.5 End points |
E.5.1 | Primary end point(s) |
overall survival (OS) - the time from the date of randomization until death due to any cause |
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E.5.1.1 | 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 |
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E.5.2 | 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)
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 23 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
China |
Georgia |
Russian Federation |
Czechia |
Hungary |
Slovakia |
Romania |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |