Clinical trial NCT03288870: Efficacy, Safety and Pharmacokinetics of BCD-100 (Anti-PD-1) Monotherapy as Second Line Treatment in Patients With Non-Small Cell Lung Cancer (DOMINUS)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Non Small Cell Lung Cancer Stage IIIB
Non-Small Cell Carcinoma of Lung, TNM Stage 4
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2017-09-20
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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
* Anti-tumor treatment ending less then 28 days before screening
* Prior therapy with anti-CTLA4 and/or anti-PD-1/PD-L1/PD-L2 drugs
* Prior therapy with docetaxel
* Concomitant oncological diseases except treated cervical carcinoma in situ or radically resected squamous-cell carcinoma
* Allergy to drugs based on monoclonal antibodies or docetaxel or polysorbate 80, severe reactions to paclitaxel
* Pregnancy and lactation

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
Secondary outcomes:
measure: Overall response rate
timeFrame: 1 year
measure: Progression-free survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Gomel
country: Belarus
facility: Gomel Regional Clinical Oncology Dispensary
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk District Clinical Oncology Dispensary
city: Krasnodar
country: Russian Federation
facility: Clinical Oncology Dispensary N1
city: Moscow
country: Russian Federation
facility: N.N. Burdenko General Military Clinical Hospital
city: Pyatigorsk
country: Russian Federation
facility: Pyatigorsk Oncology Center
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg City Clinical Oncology Center
city: St.Petersburg
country: Russian Federation
facility: N.N.Petrov Oncology Research Center
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan
Study officials:
affiliation: Vice President R&D, JSC BIOCAD
name: Roman A Ivanov, PhD
role: STUDY_DIRECTOR
References: