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

A Single-Arm Phase II Trial of Camrelizumab Plus Apatinib for Advanced Non-Squamous NSCLC Previously Treated With First-Line Immunotherapy

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Non Squamous NSCLC
• Intervention / Treatment: Drug: Apatinib; Drug: Camrelizumab

Detailed Description

This trial will evaluate the safety and efficacy of Camrelizumab plus Apatinib in participants with advanced non-squamous NSCLC previously treated with first-line immunotherapy. The primary objective of this pilot study is to determine the Camrelizumab plus Apatinib improves progression-free survival (PFS) . All the efficacy and safety are assessed by investigator : 1) response rate (ORR), 2) duration of response(DoR), 3) overall survival(OS), 4) disease control rate (DCR); the safety and quality of life assessment Explore objective is potential biomarker associated with efficacy.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Junling Li, PhD; Phone Number: 86-010-87788713; Email: drlijunling@vip.163.com
• Study Contact Backup: Name: Puyuan Xing; Phone Number: 86-010-87788713; Email: xingpuyuan@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • China
      • Contact: Junling Li, PhD; Phone Number: +861087788713; Email: drlijunling@vip.163.com
      • Contact: Puyuan Xing, PhD; Phone Number: +861087788713; Email: xingpuyuan@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Provision of signed (infomed consent form, ICF).
2. The best response of first-line immunotherapy was SD or above, and PFS was at least 3 months.
3. Male and female aged ≥18 years and ≤75 years.
4. 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.
5. 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.
6. Measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria.
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
8. Subjects are eligible if CNS metastases are asymptomatic or treated.
9. Life expectancy ≥12 weeks.
10. 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.
11. Adequate organ and marrow function.

Exclusion Criteria:

1. 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.
2. 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.
3. Subjects with histologically or cytologically-documented squamous cell NSCLC.
4. Prior treatments with anti-angiogenic agents.
5. Subjects with activated EGFR gene mutation or ALK fusion mutation.
6. 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.
7. 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).
8. History of active or recent history of known or suspected autoimmune disease.
9. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, radiation pneumonitis requiring steroid therapy, or evidence of active pneumonitis with clinical symptoms.
10. History of active tuberculosis regardless of prior treatment.
11. 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.
12. Known mental illness, alcohol abuse, inability to quit smoking, drug or drug abuse, etc.
13. Active hepatitis B or hepatitis C; History of known HIV-positive history or known AIDS.
14. Treatment with any investigational agent within 28 days of signing ICF.
15. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Camrelizumab plus Apatinib; Camrelizumab, 200mg, q3w, iv and Apatinib, 250mg, qd, po	Drug: Apatinib; A tyrosine kinase inhibitor selectively targeting VEGFR-2; Other Names: Apatinibmesylate; Drug: Camrelizumab; A human anti-PD-1 monoclonal antibody; Other Names: SHR-1210

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by investigator.	up to 1 year
Duration of Response	Duration of Response, determined using RECIST v1.1 criteria	up to 1 year
Disease Control Rate (DCR)	Disease Control Rate, determined using RECIST v1.1 criteria	up to 1 year
Overall Survival (OS)	Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up	up to 2 years
Adverse Events (AEs) and Serious Adverse Events(SAEs)	The number of participants experiencing an AE and SAE will be assessed.Adverse	up to 1 year
QLQ-LC13	Quality of Life questionnaire lung cancer module 13	up to 1 years
EORTCQLQ-C30	European Organization for Reasearch and Treatment of Cancer C30	up to 1 years

Collaborators and Investigators

• Sponsor: Junling Li

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 28, 2021
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): June 1, 2022

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (ACTUAL): December 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: programmed cell death 1 (PD-1, PD1); programmed cell death-ligand 1 (PD-L1, PDL1); anti-angiogenesis; First-Line Immunotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: NCC2607

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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