NCT04291092

Brief Summary

To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment in non-small cell lung cancer with brain metastases.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 10, 2021

Status Verified

August 1, 2021

Enrollment Period

2.5 years

First QC Date

January 8, 2020

Last Update Submit

September 3, 2021

Conditions

NSCLC Stage IVBrain MetastasesImmunotherapy

Keywords

lung cancerBrain MetastasesCamrelizumabWBRTSRS

Outcome Measures

Primary Outcomes (1)

  • 6 month progression-free survival rate

    6 month progression-free survival rate

    6 month

Study Arms (1)

single-arm

EXPERIMENTAL

single-arm

Drug: ImmunotherapyRadiation: WBRTDrug: Chemotherapy

Interventions

ImmunotherapyDRUG

Immunotherapy for brain metastasis

Also known as: Camrelizumab
single-arm
WBRTRADIATION

local therapy for brain metastasis

Also known as: SRS
single-arm
ChemotherapyDRUG

Chemotherapy for brain metastasis

single-arm

Eligibility Criteria

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

You may qualify if:

  • Age ≥18;
  • ECOG is 0-1;
  • Non-small cell lung cancer confirmed by histology; EGFR、ALK and ROS1 negative;
  • The presence of brain metastases as determined by imaging, with unlimited numbers, the intracranial lesions had a maximum diameter of ≥ 0.5cm，allowing the presence of clinical symptoms of brain metastases;
  • According to RECIST 1.1, there is at least one measurable extracranial and intracranial target lesion each;
  • Sign informed consent and agree to collect the clinical efficacy and information of the patient.

You may not qualify if:

  • Immunotherapeutic contraindications (including long-term use of hormones, history of radiation pneumonia, etc.)
  • Active autoimmune diseases (e.g. vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.)
  • Patients with active hepatitis B or C, HIV, active tuberculosis, etc.;
  • Active infections requiring antimicrobial therapy (e.g. antimicrobial, antiviral, antifungal);
  • History of known allogeneic organ transplantation and history of in vivo hematopoietic stem cell transplantation;
  • Patients with interstitial lung disease or previous history of interstitial pneumonia;
  • Having a history of substance abuse and unable to abstain from it or having mental disorders;
  • who have participated in other clinical trials of antitumor drugs within 4 weeks before entering the group;
  • Having used PD-1/PD-L1 and other immunotherapy drugs before entering the group;
  • previous or concurrent with other untreated malignancies, except for cured basal cell carcinoma of the skin, carcinoma of the cervix in situ and superficial bladder cancer;
  • (a) Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraception;
  • The researchers judged other situations that might affect the conduct of clinical studies and the determination of their findings.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Related Publications (1)

  • Xu Y, Chen K, Xu Y, Li H, Huang Z, Lu H, Huang D, Yu S, Han N, Gong L, Qin J, Chen J, Xie F, Hong W, Lin X, Cheng F, Luo X, Fan Y. Brain radiotherapy combined with camrelizumab and platinum-doublet chemotherapy for previously untreated advanced non-small-cell lung cancer with brain metastases (C-Brain): a multicentre, single-arm, phase 2 trial. Lancet Oncol. 2025 Jan;26(1):74-84. doi: 10.1016/S1470-2045(24)00643-0.

    PMID: 39756446DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungBrain NeoplasmsLung Neoplasms

Interventions

ImmunotherapycamrelizumabDrug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 8, 2020

First Posted

March 2, 2020

Study Start

January 1, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2023

Last Updated

September 10, 2021

Record last verified: 2021-08

Locations

CN(1)