Department of Medical Oncology, Zhejiang Cancer Hospital

Zhejiang Cancer Hospital1 site in 1 country21 target enrollmentAugust 1, 2019

ConditionsLung Cancer

Interventionssintilimab and anlotinib

Drugssintilimab and anlotinib

Overview

Phase: Phase 2
Intervention: sintilimab and anlotinib
Conditions: Lung Cancer
Sponsor: Zhejiang Cancer Hospital
Enrollment: 21
Locations: 1
Primary Endpoint: objective response rate (ORR)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study was a single-arm, open-label, phase II study of PD-1 monoclonal antibody combined with anlotinib in the treatment of advanced non-small cell lung cancer (NSCLC) with EGFR uncommon mutations. Twenty-one patients of NSCLC harboring rare EGFR mutations after previous treatments, including a platinum-based regimen and a targeted treatment (regardless of EGFR Ex20ins), were enrolled. Patients received sintilimab (anti-PD-1) combined with anlotinib (multi-target anti-angiogenesis). The primary endpoint was the objective response rate (ORR) based on RECIST 1.1. Secondary goals included progression-free survival (PFS), overall survival (OS), disease control rate (DCR) based on RECIST 1.1; safety Sex and tolerance. Exploratory objectives include the use of tumor tissue and plasma specimens to detect biomarkers predicting the efficacy of sidilimumab: including but not limited to tumor mutation burden (TMB), PD-L1 expression, etc.; exploring potential predictions in peripheral blood. Biomarkers for anti-group efficacy, including but not limited to TCR.

Detailed Description

This clinical trial (NCT04790409) entitled " Sintilimab Combined with Anlotinib in Advanced NSCLC with EGFR Uncommon Mutations" has been approved by the Ethics Committee of Zhejiang Cancer Hospital in June 12, 2019 (IRB-2019-81). Meanwhile, we registered our project information on the ClinicalTrials.gov PRS in June, 2019 and obtained the status of "approved". In this study, the first patient received treatment on August 26, 2019. However, due to inexperience and misunderstanding, we wrongly missed the next stage of "released" in PRS. Until we realize our mistakes, the initial release time can only be on 02/18/2021. Therefore, we amend the initial release time here.

Registry

clinicaltrials.gov

Start Date

August 1, 2019

End Date

September 13, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zhejiang Cancer Hospital

Responsible Party

Principal Investigator

Fan Yun, MD

Zhejiang Cancer Hospital

Eligibility Criteria

Inclusion Criteria

•Sign written informed consent before any trial-related processes are implemented;
•Age ≥ 18 years old and ≤ 75 years old;
•Life expectancy exceeds 3 months;
•The investigator confirmed at least one measurable lesion according to the RECIST 1.1 standard. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if it is confirmed to have progressed;
•Patients with treated metastatic or recurrent (stage IV) NSCLC confirmed by histology or cytology according to the International Association for the Study of Lung Cancer and the American Association for the Classification of Cancer Classification, 8th edition;
•The Eastern Cancer Cooperative Group (ECOG) has a fitness status score of 0 or 1;
•Patients with genetic testing (allowing PCR and NGS detection methods) confirmed uncommon mutations (EGFR G719X, L861Q, S768I, and 20ins et al.), patients can accept two or more types of EGFR rare co-mutation. Populations with the primary EGFR T790M mutation can also be included in the study.
•Patients who have experienced disease progression after at least two treatment regimens for advanced/metastatic disease must include a platinum-containing systemic chemotherapy and an EGFR-TKI treatment. Patients with EGFR 20ins who have experienced disease progression only after platinum-containing systemic chemotherapy.
•Hematological function is sufficient, defined as absolute neutrophil count ≥1.5×109 /L, platelet count ≥100 ×109 /L, hemoglobin ≥90g/L (no history of blood transfusion within 7 days);
•Hepatic function is adequate, defined as all patients with total bilirubin levels ≤ 1.5 times normal upper limit (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times ULN, or for patients with liver metastases , AST and ALT levels ≤ 5 times ULN;

Exclusion Criteria

•Histology is NSCLC, if there are small cell carcinoma, neuroendocrine carcinoma, sarcoma components, it can not be included;
•Patients with known EGFR-sensitive mutations (19-Del and L858R);
•Cavity lung squamous cell carcinoma, or non-small cell lung cancer patients with hemoptysis (\>50 mL/day);
•Patients whose tumor has invaded an important blood vessel or who is judged by the investigator to have major bleeding during the follow-up study;
•Patients with any signs or history of bleeding physique;
•Currently participating in interventional clinical research treatment, or receiving other research drugs or research equipment within 4 weeks prior to the first dose;
•Previously received the following treatments: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or against another stimulus or synergistic inhibition of T cell receptors (eg CTLA-4, OX-40, CD137) drug;
•Received a proprietary Chinese medicine or immunomodulatory drug (thymosin, interferon, interleukin, etc.) with anti-cancer indications within 2 weeks before the first dose, or received major surgery within 3 weeks before the first dose;
•Received a physical organ or blood system transplant;
•There is clinically uncontrollable pleural effusion/peritoneal effusion (patients who do not need drainage or stop drainage and have no significant increase in 3 days of effusion can be enrolled);