SBRT/LDRT in Combination With Camrelizumab and Apatinib in Metastatic Non-small Cell Lung Cancer Patient Previously Treated With PD-1/L1 Inhibitor and Chemotherapy

NCT04878107 | Unknown Phase 2

• 1 other identifier: 2021061
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

SABRE STUDY will explore effectiveness and safety of the combination therapy of camrelizumab，apatinib and SBRT/LDRT in patients with metastatic non-small Cell Lung Cancer (NSCLC) patient previously treated With PD-1/L1 Inhibitor and Chemotherapy.

Conditions

Non-Small Cell Lung Cancer

Keywords

stereotactic body radiotherapy; Low-Dose Radiation Therapy; Camrelizumab; Apatinib

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  Objective Response Rate at 6 months using RECIST1.1 criteria

  6 Weeks

Secondary Outcomes (4)

• Duration Response Rate

  6 Weeks

• Progression-free Survival

  6 Weeks

• Overall Survival

  6 Weeks

• incidence, type and severity of adverse events

  From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months)

Study Arms (2)

SBRT/LDRT + Camrelizumab +Apatinib

EXPERIMENTAL

SBRT（8Gy×3f） LDRT（2Gy×5f） Camrelizumab（200mg，q3w） Apatinib （250mg，qd）

Drug: Camrelizumab; Drug: Apatinib; Radiation: SBRT; Radiation: LDRT

SBRT + docetaxel

ACTIVE COMPARATOR

docetaxel 75mg/m2 SBRT（8Gy×3f）

Drug: Docetaxel injection; Radiation: SBRT

Interventions

Camrelizumab DRUG

Camrelizumab (AiRuiKa™), a programmed cell death 1 (PD-1) inhibitor being developed by Jiangsu Hengrui Medicine Co. Ltd

Also known as: SHR1210

SBRT/LDRT + Camrelizumab +Apatinib

Apatinib DRUG

Apatinib \[Aitan® (brand name in China)\], also known as rivoceranib, is a novel, small molecule, selective vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor

SBRT/LDRT + Camrelizumab +Apatinib

Docetaxel injection DRUG

Docetaxel is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug

SBRT + docetaxel

SBRT RADIATION

Stereotactic body radiation therapy (SBRT) is a cancer treatment that delivers extremely precise, very intense doses of radiation to cancer cells while minimizing damage to healthy tissue. SBRT involves the use of sophisticated image guidance that pinpoints the exact three-dimensional location of a tumor so that the radiation can be more precisely delivered to cancer cells.

SBRT + docetaxel; SBRT/LDRT + Camrelizumab +Apatinib

LDRT RADIATION

low dose radation therapy

SBRT/LDRT + Camrelizumab +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:

• Histological or cytological diagnosis of non-small cell lung cancer（NSCLC）
• Has previous treatment with PD-1/L1 monoclonal antibody in combination with a platinum-based chemotherapy with outcome of complete remission (CR), partial remission (PR), or stable disease (SD) for ≥ 6 months
• Has at least two disseminated lesions for LDRT and SBRT, respectively
• Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
• Has confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) or ROS Proto-Oncogene 1(ROS1)-directed therapy is not indicated
• Has adequate organ function
• For female subjects of childbearing potential, a serum pregnancy test should be performed within 7 days prior to the administration of the first study intervention (study drug, radiation therapy) and have a negative result. Subjects are required to agree to use highly effective contraception (i.e., a method with a failure rate of less than 1% per year) and continue until at least 180 days after discontinuation of trial treatment

You may not qualify if:

• Imaging (CT or MRI) shows evidence of tumour invasion of large blood vessels or poorly demarcated blood vessels or the presence of cavities and necrotic lesions in the lungs
• With active bleeding or perforation or a hereditary or acquired bleeding tendency present, with a daily haemoptysis of ≥2.5mL in the 3 months prior to screening.
• with hypertensive disorders that cannot be reduced to the normal range with antihypertensive medication (systolic blood pressure ≤ 140 mmHg / diastolic blood pressure ≤ 90 mmHg).
• Urine routine suggesting urine protein ≥ (++) and 24-hour urine protein amount ≥ 1.0g.
• presence of thrombotic disease requiring long-term anticoagulation with warfarin or heparin, or requiring long-term antiplatelet therapy (aspirin ≥ 300 mg/day or clopidogrel ≥ 75 mg/day).
• Previous systemic antitumour therapy other than PD-1(L1) monoclonal antibody in combination with platinum-based chemotherapy, or previous treatment with anti-angiogenic agents (including bevacizumab, apatinib, anlotinib, etc.).
• Immune-related adverse events in previous PD-1(L1) therapy leading to treatment discontinuation
• Symptomatic, untreated or actively progressing central nervous system (CNS) metastases are confirmed by CT or MRI assessment during screening and prior to radiographic evaluation.
• Subjects with grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (QTc interval \> 450 ms for males and QTc interval \> 470 ms for females). Subjects with grade III-IV cardiac insufficiency or with left ventricular ejection fraction (LVEF) less than 50% according to NYHA criteria
• Has known history of Human Immunodeficiency Virus (HIV)
• Untreated active hepatitis B
• Subjects have active hepatitis B

Sponsors & Collaborators

• Wuhan University: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

camrelizumab; apatinib; Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• CongHua Xie, MD

  Wuhan University

  PRINCIPAL INVESTIGATOR

• You Lu, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CongHua Xie, MD

CONTACT

02767812510; chxie_65@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Radiation and Medical Oncology

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 7, 2021
• Study Start: March 15, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)