NCT03288870

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
218

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2017

Typical duration for phase_2

Geographic Reach
2 countries

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

September 19, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2021

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

2.9 years

First QC Date

August 23, 2017

Last Update Submit

October 28, 2020

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Percent of patients who are alive after 1 year of therapy

    1 year

Secondary Outcomes (2)

  • Overall response rate

    1 year

  • Progression-free survival

    1 year

Study Arms (2)

BCD-100 monotherapy

EXPERIMENTAL

Patients will receive solution of BCD-100 in a dose 3 mg/kg every 3 weeks as intravenous infusion until progression of the disease or signs of intolerable toxicity

Drug: BCD-100

Docetaxel monotherapy

ACTIVE COMPARATOR

Patients will receive solution of docetaxel in a dose 75 mg per square meter every 3 weeks as intravenous infusion until progression of the disease or signs of intolerable toxicity, maximum 6 cycles

Drug: Docetaxel

Interventions

BCD-100DRUG

monoclonal antibody to PD-1 receptor

BCD-100 monotherapy
DocetaxelDRUG

Chemotherapy drug (taxane)

Docetaxel monotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Gomel Regional Clinical Oncology Dispensary

Homyel, Belarus

Location

Arkhangelsk District Clinical Oncology Dispensary

Arkhangelsk, 163045, Russia

Location

Clinical Oncology Dispensary N1

Krasnodar, 350040, Russia

Location

N.N. Burdenko General Military Clinical Hospital

Moscow, 105229, Russia

Location

Pyatigorsk Oncology Center

Pyatigorsk, 357502, Russia

Location

Saint Petersburg City Clinical Oncology Center

Saint Petersburg, 197022, Russia

Location

N.N.Petrov Oncology Research Center

Saint Petersburg, 197758, Russia

Location

Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan

Ufa, 450054, Russia

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Roman A Ivanov, PhD

    Vice President R&D, JSC BIOCAD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2017

First Posted

September 20, 2017

Study Start

September 19, 2017

Primary Completion

August 10, 2020

Study Completion

August 10, 2021

Last Updated

October 29, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

RU(7)BE(1)