A Study of Camrelizumab Plus Apatinib as Consolidation Therapy in Non-Small Cell Lung Cancer Patients Treated With Chemoradiotherapy

NCT04749394 | Unknown Phase 2

• 1 other identifier: NCC004692
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II, open-Label, multi-centre study to determine the efficacy and safety of Camrelizumab plus apatinib in participants with unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), who have not progressed following platinum-based concurrent chemoradiation therapy (cCRT) or sequential chemoradiation therapy (sCRT). This study will be conducted in China mainland.

Conditions

Locally Advanced Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Programmed cell death 1 (PD-1, PD1); Anti VEGF; Chemoradiotherapy

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).

  From the first date of treatment until the date of objective disease progression or death (up to maximum 24 months)

Secondary Outcomes (10)

• Overall Survival (OS)

  up to approximately 36 months

• PFS at 12 months (PFS12)

  up to maximum 12 months

• PFS at 18 months (PFS18)

  up to maximum 18 months

• OS at 12 months (OS12)

  up to maximum 12 months

• OS at 24 months (OS24)

  up to maximum 24 months

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Camrelizumab plus apatinib as consolidation therapy

Drug: Camrelizumab, PD-1 monoclonal antibody; Drug: Apatinib, VEGFR2 antibody

Interventions

Camrelizumab, PD-1 monoclonal antibody DRUG

Camrelizumab 200mg IV, Q3W, until clinical progression/deterioration or confirmed radiological progression, or up to 1 year.

Also known as: SHR-1210

Experimental Arm

Apatinib, VEGFR2 antibody DRUG

Apatinib 250mg PO, QD, until clinical progression/deterioration or confirmed radiological progression, or up to 1 year.

Also known as: Apatinib Mesylate

Experimental Arm

Eligibility Criteria

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

You may qualify if:

• Patients aged ≥18 years, male and female are not limited;
• Patients with ECOG score of 0-1;
• Life expectancy ≥12 weeks;
• Patients must have histologically or cytologicallyproved NSCLC, and present with locally advanced, unresectable Stage III disease(according to 8th AJCC/UICC Classification);
• Receipt of concurrent or sequential chemoradiation therapy which must have been completed within 42 days prior to first dose administration of the study; Consolidation chemotherapy is not permitted.
• No progression following definitive, platinum-based, concurrent or sequential chemoradiation therapy;
• Subject with prior anti-cancer treatment can only be enrolled when all toxicities of prior anti-cancer treatment has recovered to baseline or ≤ Grade 1, except for hearing loss, alopecia and fatigue. (according to National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] V5.0);
• No prior exposure to any anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-VEGF treatments, as well as therapeutic anticancer vaccines;
• Agreement to provide tumor histological specimens required for this study;
• Adequate organ and marrow function required;
• Fertile female were required to have a negative serum or urine pregnancy test within 72 days before the start dose of study medication; If female of childbearing potential, is willing to use adequate contraception for the course of the study through 90 days after the last dose of study medication; if male with a female partner(s) of child-bearing potential, he must agree to use adequate contraception starting with the first dose of study medication through 90 days after the last dose of study medication or have been surgically sterilized;
• Provision of signed ICF.

You may not qualify if:

• Mixed small cell lung cancer histology;
• Disease progression after concurrent/sequential chemoradiotherapy;
• Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of treatment;
• Receipt of live attenuated vaccine within 28 days prior to the first dose of treatment;
• Previous enrolment of another study and receiving any study drug within 28 days prior to the first dose of treatment;
• Patients with ≥Grade 2 pneumonitis from the prior anti-cancerchemoradiation therapy;
• Imaging (CT or MRI) shows the tumor invading large vessels or blurring the boundary with vessels;
• History of organ transplant or allogeneic hematopoietic stem cell transplantation;
• Patients with any active autoimmune disease or history of autoimmune disease;
• Patients with innate or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection;
• Uuntreated active hepatitis B or, hepatitis C or active tuberculosis or currently receiving anti-tuberculosis treatment co-infection with hepatitis B and hepatitis C;
• Subjects receiving systemic treatment with corticosteroids (\>10mg/day of prednisone or its equivalent) or other immunosuppressants within 14 days prior to the first administration;
• History of another primary malignancy within 5 years prior to enrollment, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study;
• Pulmonary function test: FEV1\< 1.2L or DLCO \< 50% of predicted value;
• Patients with cardiac insufficiencyheart diseases including: 1) NYHA III-IV; 2）Acute coronary syndrome; 3) Supraventricular or ventricular arrhythmias requiring clinical intervention; 4) Pericardial and myocardial diseases; 5) Echocardiography indicates that the left ventricular ejection fraction (LVEF) is \< 50%;

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Zhouguang Hui

CONTACT

18611876792; drhuizg@163.com

Yirui Zhai

CONTACT

18610168510; januarywind@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: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Director of VIP Department

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 11, 2021
• Study Start: March 17, 2021
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 16, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)