Toripalimab Combined With Bevacizumab, Nab-paclitaxel and Carboplatin for Untreated Metastatic Pulmonary Sarcomatoid Carcinoma

NCT04725448 | Unknown Phase 2

• 1 other identifier: JS001-ISS-CO200
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the efficacy and safety of first-line Toripalimab combined with bevacizumab, nab-paclitaxel and carboplatin in the treatment of patients with advanced pulmonary sarcomatoid carcinoma.

Conditions

Pulmonary Sarcomatoid Carcinoma; Non-small Cell Lung Cancer; Lung Diseases; Thoracic Neoplasms

Keywords

PSC; NSCLC; Toripalimab; immunity therapy; Anti-angiogenesis; Platinum-containing dual-agent chemotherapy

Outcome Measures

Primary Outcomes (1)

• Progress Free Survival(PFS)

  It is defined as the time interval from randomization of patients to disease progression or death, whichever comes first. There was no progress or the time of disease progression was not recorded when the trial was withdrawn, and the date of the last examination was used as the end date.

  up to 2 years

Secondary Outcomes (5)

• Overall response rate(ORR)

  up to 2 years

• Disease Control Rate(DCR)

  up to 2 years

• Overall Survival(OS)

  up to 2 years

• Incidence of AEs

  up to 2 years

• the quality of life (QoL)

  up to 2 years

Study Arms (1)

Toripalimab Combined With Bevacizumab, Nab-paclitaxel and Carboplatin

EXPERIMENTAL

Drugs: Toripalimab, 240mg (6ml)/bottle, ivgtt, d1, q3w, administration until PD or death, the longest use time is two years. Drugs: Bevacizumab, 7.5mg/kg, ivgtt, d1, q3w,the longest use time is two years. Drugs: Nab-paclitaxel, 260mg/m2,ivgtt,d1 or 130mg/m2,ivgtt,d1,8, q3w, up to six cycles. Drugs: Carboplatin, AUC=4～5, ivgtt, d1, q3w, up to six cycles.

Drug: Toripalimab; Drug: Bevacizumab; Drug: Nab-paclitaxel; Drug: Carboplatin

Interventions

Toripalimab DRUG

240mg, ivgtt, d1, every 3 weeks until disease progress or intolerable toxicity, up to 2 years of administration

Also known as: JS001, Toripalimab Injection, TuoYI, Teruipuli Dankang

Toripalimab Combined With Bevacizumab, Nab-paclitaxel and Carboplatin

Bevacizumab DRUG

7.5mg/kg, ivgtt, d1, every 3 weeks, up to 2 years of administration

Also known as: Bevacizumab Injection, Avastin, Bei Fa Zhu Dankang Zhusheye

Toripalimab Combined With Bevacizumab, Nab-paclitaxel and Carboplatin

Nab-paclitaxel DRUG

260mg/m2,d1 or 130mg/m2,d1,8, ivgtt, every 3 weeks, up to 6 cycles

Also known as: ABRAXANE, paclitaxel protein-bound particles for injectable suspension

Toripalimab Combined With Bevacizumab, Nab-paclitaxel and Carboplatin

Carboplatin DRUG

AUC=4～5, d1, ivgtt, every 3 weeks, up to 6 cycles

Also known as: Carboplatin injection

Toripalimab Combined With Bevacizumab, Nab-paclitaxel and Carboplatin

Eligibility Criteria

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

You may qualify if:

• to 75 years old, no gender limit;
• ECOG PS: 0～2 points;
• Untreated patients with stage IV pulmonary sarcomatoid carcinoma are staged according to the AJCC eighth edition non-small cell lung cancer staging standard;
• Pulmonary sarcomatoid carcinoma confirmed by histopathology has at least one measurable lesion according to RECIST standard 1.1, and the lesion has not received radiotherapy;
• The functions of important organs meet the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before the start of the research treatment) : Absolute Neutrophil Count (ANC) ≥1.5×10 E+9/L, Hemoglobin (HB) ≥9g/dL, Platelets (PLT)≥90×10 E+9/L, Serum Albumin (ALB)≥2.8g/dL, Total Bilirubin (TBIL) ≤1.5 ULN, ALT、AST≤2.5 UILN(If abnormal liver function is caused by liver metastasis, ≤5 ULN), Serum creatinine sCr≤1.5 ULN, endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula) ,Normal thyroid function;
• Expected survival time ≥ 3 months;
• Female subjects with fertility should undergo a urine or serum pregnancy test within 72 hours before receiving the first study drug administration, and prove to be negative, and are willing to use effective during the test period to 3 months after the last administration Methods of contraception. For male subjects whose partners are women of childbearing age, effective methods of contraception should be used during the trial and within 3 months after the last administration;
• The patients joined the study voluntarily and signed an informed consent form (ICF). They had good compliance and cooperated with follow-up.

You may not qualify if:

• There is known evidence that patients have mutations in any of the genes above EGFR, ROS-1, ALK, and c-MET;
• Suffer from any active autoimmune diseases, such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy is normal);
• Known to be allergic to other monoclonal macromolecular protein preparations, or to any of the components of Toripalimab;
• Have received other PD-1 monoclonal antibody therapy or other immunotherapy against PD-1/PD-L1;
• Active infection or fever of unknown origin occurred during the screening period and before the first administration\>38.5℃ (according to the judgment of the investigator, the subject can be included in the group for fever caused by the tumor);
• Suffering from uncontrolled clinical symptoms or diseases of the heart, such as: (1) Heart failure above NYHA II; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmia requiring clinical intervention.
• Suffering from high blood pressure and cannot be well controlled by antihypertensive drugs (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
• Abnormal coagulation function (INR\>2.0, PT\>16s), have bleeding tendency or are receiving thrombolytic therapy, and allow preventive use of low-dose aspirin and low-molecular-weight heparin;
• Obvious coughing up blood or hemoptysis of 10ml or more per day in the 2 months before enrollment;
• Have significant clinically significant bleeding symptoms or have a clear bleeding tendency within 3 months before enrollment;
• Suffer from congenital or acquired immune function defects (such as HIV infection);
• Received anti-tumor monoclonal antibody (mAb) within 4 weeks before the first use of the study drug, or the adverse event caused by the previously received drug has not recovered (ie ≤ grade 1 or reached the baseline level). Note: Except for subjects with ≤ Grade 2 neuropathy or ≤ Grade 2 hair loss, if the subject has undergone major surgery, the toxic reaction and/or complications caused by the surgical intervention must be fully recovered before starting treatment;
• Live vaccines have been vaccinated within 4 weeks before the first use of the study drug. Inactivated virus vaccines for seasonal influenza and injection are allowed, but live attenuated influenza vaccines for nasal use are not allowed;
• According to the judgment of the investigator, the subject has other factors that may cause him to be forced to terminate the study halfway, such as suffering from other serious diseases (including mental illness) requiring combined treatment, severely abnormal laboratory test values, family or social factors, It may affect the safety of subjects or the collection of experimental data;

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Sichuan Cancer Hospital

Chengdu, Sichuan/China, 610041, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Diseases; Thoracic Neoplasms

Interventions

toripalimab; Bevacizumab; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Coordination Complexes

Study Officials

• Juan Li, MD

  Sichuan Cancer Hospital and Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Li, MD

CONTACT

+8613880276636; dr.lijuan@gmail.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: MD

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 26, 2021
• Study Start: April 6, 2021
• Primary Completion: March 1, 2022
• Study Completion: November 30, 2023
• Last Updated: April 6, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)