Camrelizumab Combined With Local Treatment in NSCLC Patients With BM

Camrelizumab Combined With Chemotherapy and Local Treatment in Non-small Cell Lung Cancer Patients With Brain Metastasis, a Single-arm, Multi-center, Open-labeled Phase II Clinical Trial

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

Study Overview

• Status: Recruiting
• Conditions: Brain Metastases; NSCLC Stage IV; Immunotherapy
• Intervention / Treatment: Drug: Immunotherapy; Radiation: WBRT; Drug: Chemotherapy

Detailed Description

To evaluate the efficacy and safety of Camrelizumab Combined with Chemotherapy and Local Treatment of brain metastases (WBRT, r-knife, SRS, etc.) in non-small cell lung cancer patients with brain metastases .

• Study Type: Interventional
• Enrollment (Anticipated): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: Yun Fan, Dr; Phone Number: +86 057188122092; Email: fanyun@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥18;
2. ECOG is 0-1;
3. Non-small cell lung cancer confirmed by histology; EGFR、ALK and ROS1 negative;
4. 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;
5. According to RECIST 1.1, there is at least one measurable extracranial and intracranial target lesion each;
6. Sign informed consent and agree to collect the clinical efficacy and information of the patient.

Exclusion Criteria:

1. Immunotherapeutic contraindications (including long-term use of hormones, history of radiation pneumonia, etc.)
2. Active autoimmune diseases (e.g. vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.)
3. Patients with active hepatitis B or C, HIV, active tuberculosis, etc.;
4. Active infections requiring antimicrobial therapy (e.g. antimicrobial, antiviral, antifungal);
5. History of known allogeneic organ transplantation and history of in vivo hematopoietic stem cell transplantation;
6. Patients with interstitial lung disease or previous history of interstitial pneumonia;
7. Having a history of substance abuse and unable to abstain from it or having mental disorders;
8. who have participated in other clinical trials of antitumor drugs within 4 weeks before entering the group;
9. Having used PD-1/PD-L1 and other immunotherapy drugs before entering the group;
10. 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;
11. (a) Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraception;
12. The researchers judged other situations that might affect the conduct of clinical studies and the determination of their findings.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single-arm	Drug: Immunotherapy; Immunotherapy for brain metastasis; Other Names: Camrelizumab; Radiation: WBRT; local therapy for brain metastasis; Other Names: SRS; Drug: Chemotherapy; Chemotherapy for brain metastasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 month progression-free survival rate	6 month progression-free survival rate	6 month

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: February 27, 2020
• First Posted (Actual): March 2, 2020

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: lung cancer; WBRT; Brain Metastases; SRS; Camrelizumab
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neoplastic Processes; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasm Metastasis; Brain Neoplasms
• Other Study ID Numbers: XYJ20200101-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No