Rh-endostatin Combined With Chemotherapy and Pembrolizumab for Advanced NSCLC

NCT04094909 | Unknown Phase 2

• 1 other identifier: CROC1902
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to investigate that efficacy and safety of rh-endostatin（Endostar）combined with platinum-based doublet chemotherapy and Pembrolizumab as first line therapy in patients with advanced or metastatic non-small-cell lung cancer.

Conditions

Staging IV NSCLC

Keywords

rh-endostatin; Pembrolizumab; NSCLC; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• PFS

  from the enrolment to PD or death

  6-10 months

Secondary Outcomes (1)

• OS

  14-18 months

Study Arms (1)

Rh-endostatin + chemotherapy+Pembrolizumab

EXPERIMENTAL

The subjects are 186, including Squamous and Non-Squamous NSCLC. Squamous NSCLC receives rh-endostatin at a dose of 15mg/m2 for 5 days and 200 mg of pembrolizumab at day 1 in each cycle, repeating every 3 weeks till to PD or unacceptable toxicities. all the patients with squamous NSCLC also receive carboplatin (5U/AUC) or cisplatin ( 75mg/m2) and \[nab\]-paclitaxel (100mg/m2) for the first 4 cycles. For non-squamous NSCLC, rh-endostatin at dose of 15mg/m2 for 5 days, 200 mg of pembrolizumab at day 1 and pemetrexed (500mg/m2,d1) are given in each cycle, repeating every 3 weeks till to PD or unacceptable toxicities. Non-squamous NSCLC also receive carboplatin (5U/AUC) or cisplatin ( 75mg/m2) and pemetrexed (500mg/m2,d1) for the first 4 cycles.

Drug: Rh-endostatin

Interventions

Rh-endostatin DRUG

Squamous NSCLC: Rh-endostatin+Pembrolizumab+carboplatin or cisplatin +\[nab\]-paclitaxel during the treatment. Rh-endostatin+Pembrolizumab during the maintenance period. Non-squamous NSCLC: Rh-endostatin+Pembrolizumab+carboplatin or cisplatin +pemetrexed during the treatment. Rh-endostatin+Pembrolizumab + pemetrexed during the maintenance period.

Also known as: Pembrolizumab, carboplatin, cisplatin, pemetrexed, [nab]-paclitaxel

Rh-endostatin + chemotherapy+Pembrolizumab

Eligibility Criteria

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

You may qualify if:

• Sign informed consent.
• Patients aged 18 to 75.
• According to the TNM staging of lung cancer in the 8th edition of the International Association for Lung Cancer Research and the Joint Committee on Cancer Classification of the United States, NSCLC with local advanced or metastatic stage (stage III B, III C or IV) confirmed by histology or cytology can not be treated surgically and can not be accepted by radical concurrent radiotherapy and chemotherapy.
• There must be at least one measurable lesion.
• ECOG PS was 0-1.
• NSCLC with driving gene was negative.
• Patients who had not received systemic radiotherapy or chemotherapy before or who had relapsed more than 6 months after the end of adjuvant chemotherapy were followed up.
• Patient's survival more than 3months.
• The liver and kidney function is normal.

You may not qualify if:

• The subjects had cancerous meningitis.
• Patients with active central nervous system (CNS) metastasis should be excluded. If the patients with CNS metastasis can be adequately treated and the neurological symptoms of the subjects can be restored to baseline level at least two weeks before enrollment (except for residual signs or symptoms related to CNS treatment), who can be participated in the study. In addition, patients who do not use corticosteroids, or receive prednisone (or equivalent) at a steady or decreasing dose of less than 10 mg/day.
• Patients with active, known or suspected autoimmune diseases were excluded. Patients with type I diabetes mellitus, hypothyroidism requiring hormone replacement therapy, skin disorders requiring no systemic treatment (e.g., vitiligo, psoriasis or alopecia), or who are not expected to reappear without external triggers may be included.
• Within 14 days before admission, subjects requiring systemic corticosteroids (dose equivalent to \> 10 mg prednisone/day) or other immunosuppressive drugs were included. Patients who used inhaled or topical corticosteroids, and those who received corticosteroid replacement therapy at doses equal to more than 10 mg of prednisone per day, could participate in the study if there were no active autoimmune diseases.
• Hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus antibody (HCV Ab) are positive, indicating acute or chronic infection.
• According to chest X-ray examination, sputum examination and clinical examination, active pulmonary tuberculosis (TB) infection was judged. Patients with a history of active pulmonary tuberculosis infection in the previous year should be excluded even if they have been treated; patients with a history of active pulmonary tuberculosis infection more than a year ago should also be excluded unless the course and type of antituberculosis treatment previously used are proved to be appropriate.
• Previous serious heart disease patients include congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction, severe valvular disease and intractable hypertension.
• Pregnant or lactating patients.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

Zhou Chengzhi

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Interventions

pembrolizumab; Carboplatin; Cisplatin; Pemetrexed; Taxes

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Economics; Health Care Economics and Organizations

Study Officials

• Likun Chen, professor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chengzhi Zhou, professor

CONTACT

13560351186; doctorzcz@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: Professor

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: February 6, 2020
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)