Camrelizumab Plus Apatinib for Advanced Non-Squamous NSCLC Previously Treated With First-Line Immunotherapy

NCT04670913 | Unknown Phase 2

• 1 other identifier: NCC2607
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy and safety of Camrelizumab plus Apatinib in the treatment of advanced non-squamous NSCLC previously treated with first-line immunotherapy

Conditions

Advanced Non Squamous NSCLC

Keywords

programmed cell death 1 (PD-1, PD1); programmed cell death-ligand 1 (PD-L1, PDL1); anti-angiogenesis; First-Line Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  PFS is determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

  up to 1 year

Secondary Outcomes (7)

• Objective response rate (ORR)

  up to 1 year

• Duration of Response

  up to 1 year

• Disease Control Rate (DCR)

  up to 1 year

• Overall Survival (OS)

  up to 2 years

• Adverse Events (AEs) and Serious Adverse Events(SAEs)

  up to 1 year

Study Arms (1)

Camrelizumab plus Apatinib

EXPERIMENTAL

Camrelizumab, 200mg, q3w, iv and Apatinib, 250mg, qd, po

Drug: Camrelizumab; Drug: Apatinib

Interventions

Camrelizumab DRUG

A human anti-PD-1 monoclonal antibody

Also known as: SHR-1210

Camrelizumab plus Apatinib

Apatinib DRUG

A tyrosine kinase inhibitor selectively targeting VEGFR-2

Also known as: Apatinibmesylate

Camrelizumab plus Apatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed (infomed consent form, ICF).
• The best response of first-line immunotherapy was SD or above, and PFS was at least 3 months.
• Male and female aged ≥18 years and ≤75 years.
• Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy.
• Patients who are unwilling to receive chemotherapy after disease recurrence or progression during/after first-line treatment including PD-(L)1 combined with chemotherapy, and PD-(L)1 monotherapy for advanced or metastatic disease.
• Measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• Subjects are eligible if CNS metastases are asymptomatic or treated.
• Life expectancy ≥12 weeks.
• Fertile female must agree to use adequate contraception within 24 weeks from the beginning of the first dose of study medication to the last dose.
• Adequate organ and marrow function.

You may not qualify if:

• Prior treatment with anti-tumor virus, or prior T cell co-stimulation factors,including anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody or other T cell-targeted drugs.
• Subjects who had discontinued prior treatment due to immune-related adverse events (irAEs) or who are not suitable for PD-(L)1 treatment assessed by the investigator.
• Subjects with histologically or cytologically-documented squamous cell NSCLC.
• Prior treatments with anti-angiogenic agents.
• Subjects with activated EGFR gene mutation or ALK fusion mutation.
• Untreated or active central nervous system metastases (such as brain or meningeal metastases). Subjects are eligible if CNS metastases are asymptomatic or treated and subjects are off corticosteroids for at least 2 weeks prior to first dose of study therapy.
• Radiotherapy for the chest and whole brain should be completed within 4 weeks before the first dose of study drug (palliative radiotherapy for bone lesions should be completed before the first dose of study drugs).
• History of active or recent history of known or suspected autoimmune disease.
• History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, radiation pneumonitis requiring steroid therapy, or evidence of active pneumonitis with clinical symptoms.
• History of active tuberculosis regardless of prior treatment.
• Malignancies other than NSCLC within 5 years prior to first administration of drugs, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome, such as cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection.
• Known mental illness, alcohol abuse, inability to quit smoking, drug or drug abuse, etc.
• Active hepatitis B or hepatitis C; History of known HIV-positive history or known AIDS.
• Treatment with any investigational agent within 28 days of signing ICF.
• According to the judgment of the investigator, subjects have other factors that may cause the study to be terminated halfway, such as non-compliance with the protocol, other serious diseases (including mental illness) requiring combined treatment, severe laboratory abnormalities, and Factors such as family or society will affect the safety of subjects or the collection of data and samples.

Sponsors & Collaborators

• Junling Li: lead

Study Sites (1)

China

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (1)

• Xing P, Wang M, Zhao J, Zhong W, Chi Y, Xu Z, Li J. Study protocol: A single-arm, multicenter, phase II trial of camrelizumab plus apatinib for advanced nonsquamous NSCLC previously treated with first-line immunotherapy. Thorac Cancer. 2021 Oct;12(20):2825-2828. doi: 10.1111/1759-7714.14113. Epub 2021 Aug 18.

  PMID: 34409776 DERIVED

MeSH Terms

Conditions

Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

camrelizumab; apatinib

Central Study Contacts

Junling Li, PhD

CONTACT

86-010-87788713; drlijunling@vip.163.com

Puyuan Xing

CONTACT

86-010-87788713; xingpuyuan@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Junling Li, Chief Physician, Medical Doctor, PhD Tutor, Internal Medicine-Oncology, Chinese Academy of Medical Sciences Cancer Hospital

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 17, 2020
• Study Start: June 28, 2021
• Primary Completion: December 1, 2021
• Study Completion: June 1, 2022
• Last Updated: June 29, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)