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Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS) | Clinical Trials | Clareo Health

UNKNOWNPHASE2/PHASE3

Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)

International Multi-center Open-label Randomized Clinical Trial of Efficacy, Safety and Pharmacokinetics of BCD-100 (JSC "BIOCAD", Russia) Monotherapy Compared to Docetaxel as Second-line Therapy of Patients With Advanced Inoperable or Metastatic Non-small Cell Lung Cancer

NCT03288870•Biocad

View on ClinicalTrials.gov

Summary

International multi-center open-label randomized clinical trial of efficacy, safety and pharmacokinetics of BCD-100 (JSC BIOCAD, Russia) monotherapy compared to docetaxel as second-line therapy of patients with advanced inoperable or metastatic non-small cell lung cancer

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Verified diagnosis of non-small cell lung cancer
•Verified progression of the disease after or during first-line chemotherapy based on platinum drugs
•Absence of mutation of EGFR and ALK genes
•ECOG score 0-1
•At least one lesion, that is measurable according to RECIST 1.1 criteria
•Absence of severe organ pathology
•Anticipated live duration more that 12 weeks after screening
•Brain metastases with clinical symptoms requiring glucocorticoids and/or anticonvulsant drugs

Exclusion Criteria

•EGFR and/or ALK mutations
•Patients with severe of live-threatening acute complications of the disease
•Intersticial lung diseases or pneumonitis
•Concomitant diseases that affect safety evaluation
•Autoimmune diseases
•Endocrine diseases that could not be compensated by hormonal therapy
•Patient needs glucocorticoids
•Significant liver or renal diseases
•Lactate dehydrogenase exceeds upper limit of normal more that 2-fold
•More that 1 chemotherapy lines for advanced/metastatic non-small cell lung cancer treatment
+6 more criteria

Locations (8)

Gomel Regional Clinical Oncology Dispensary

Homyel, Belarus

Arkhangelsk District Clinical Oncology Dispensary

Arkhangelsk, Russia

Clinical Oncology Dispensary N1

Krasnodar, Russia

N.N. Burdenko General Military Clinical Hospital

Moscow, Russia

Pyatigorsk Oncology Center

Pyatigorsk, Russia

Saint Petersburg City Clinical Oncology Center

Saint Petersburg, Russia

N.N.Petrov Oncology Research Center

Saint Petersburg, Russia

Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan

Ufa, Russia

Key Dates

Start Date

September 19, 2017

Primary Completion Date

August 10, 2020

Completion Date

August 10, 2021

Last Updated

October 29, 2020

Enrollment

218

ESTIMATED participants

Conditions

Non Small Cell Lung Cancer Stage IIIBNon-Small Cell Carcinoma of Lung, TNM Stage 4

Interventions

BCD-100

DRUG

Docetaxel

DRUG

A Study of Sargramostim Plus Pembrolizumab with or Without Pemetrexed in Patients with Advance Non-small Cell Lung Cancer After Completion of Chemoimmunotherapy

NCT04856176

Advanced Lung Non-Small Cell CarcinomaNon-Small Cell Carcinoma of Lung, TNM Stage 4

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 29, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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