CM082 and JS001 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC).

NCT03848611 | Unknown Phase 2

• 1 other identifier: CM082-CA-IV-401
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a one-arm, single-center, phase II clinical study. Patients who meet the enrollment criteria will receive CM082 tablets 150mg once daily (qd) orally (taken within half an hour after daily breakfast) in combination with JS001 (3mg/kg, once every 2 weeks, q2w), every 28 days a treatment cycle until the disease progresses, the toxicity is intolerable, the investigator or subject decides to withdraw, loses to follow up, starts using other anti-tumor treatments or dies.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate according to RECIST 1.1

  The proportion of patients with complete remission (CR) and partial remission (PR) in all patients.Disease progression will be evaluated according to RECIST 1.1.

  12 months

Secondary Outcomes (5)

• Disease Control Rate according to RECIST 1.1 and iRECIST

  12 months

• Duration of Response according to RECIST 1.1 and iRECIST

  12 months

• Time to Response to RECIST 1.1 and iRECIST

  12 months

• Progression-free survival

  12 months

• Overall survival

  36 months

Study Arms (1)

CM082 plus JS001

EXPERIMENTAL

Patients who meet the enrollment criteria will receive CM082 tablets 150mg once daily (qd) orally (taken within half an hour after daily breakfast) in combination with JS001 (3mg/kg, once every 2 weeks, q2w), every 28 days A treatment cycle until the disease progresses, the toxicity is intolerable, the investigator or subject decides to withdraw, loses to follow up, starts using other anti-tumor treatments or dies.

Drug: CM082 plus JS001

Interventions

CM082 plus JS001 DRUG

CM082：150mg once a day (qd) orally (taken within half an hour after breakfast). JS001 :An intravenous infusion of a solution having a concentration of 1-10 mg/ml was prepared with 0.9% physiological saline, and administered once every two weeks. Using an inline filter (0.2 or 0.22 μm), the drug was diluted with physiological saline and intravenously administered within 60 minutes.

Also known as: Vorolanib plus Toripalimab Injection

CM082 plus JS001

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed diagnosis of recurrence after surgery, inoperable resection or metastasis advanced NSCLC (III/IV period), with no specific driver gene mutations (EGFR or ALK).
• Has not received any systemic anti-tumor medication or adjust the chemotherapy regimen because of intolerance( but the treatment should be completed for at least 4 weeks prior to the first dose of study drug, and all related toxicity events have returned to normal or no more than Grade I of CTCAE 4.03, except for hair loss).
• Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1.
• Life expectancy of at least 12 weeks.
• All patients are suggested tumor tissue specimens (preferably fresh tissue specimens) for PD-L1 expression analysis prior to enrollment. If the subject did not undergo a pathological examination before participating in the trial, the collected tumor tissue specimens will also be used for pathological examination to confirm the diagnosis of NSCLC.
• There is at least one measurable lesion according to the RECIST 1.1 standard and the lesion has not received radiotherapy.
• Patients may have a history of brain/meningeal metastases, but must undergo topical treatment (surgery/radiotherapy) and be clinically stable for at least 3 months prior to the start of the study .If corticosteroids have been used before, they should be discontinued for at least 2 weeks before the first dose of study drug.
• The level of organ function must meet the following requirements (7 days before the first dose of study drug):
• Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L, platelet (PLT) ≥ 100 × 109 / L, hemoglobin (HB) ≥ 9g / dL (no blood transfusion or receiving blood components within 14 days before detection);
• Liver: serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal（ULN）, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5\*ULN (if liver metastasis, AST, ALT allowed) ≤ 5 \*ULN);
• Serum creatinine ≤ 1.5\*ULN and endogenous creatinine clearance ≥ 50milliliter(ml) / min (Cockcroft-Gault formula);
• Well-controlled hypertensive patients can be enrolled;
• International normalized ratio (INR), activated partial thromboplastin time (aPTT) ≤ 1.5 \*ULN for patients who have not received anticoagulant therapy; patients who receive anticoagulant therapy should be treated within the requirements of label
• Urine protein ≤ 1+, if urine protein \> 1+, 24 hours urine protein measurement is required, the total amount of which needs ≤ 1 gram;
• Free Triiodothyronine(FT3), Free Thyroxine(FT4), Thyroid-Stimulating Hormone(TSH) normal or abnormal has no clinical significance;

You may not qualify if:

• Patients who have previously received anti-PD-1, anti-PD-L1, anti-PD-L2 therapy, or VEGFR Tyrosine Kinase Inhibitors(TKI) therapy.
• Patients currently receiving anti-tumor treatment.
• Patients who received large surgery within 4 weeks before the first dose of the test drug or has not recovered from the side effects of this operation, received live vaccination or immunotherapy within 4 weeks before the first dose of the test drug, and radiotherapy was performed within 2 weeks.
• Subjects with a history of malignancy (unless NSCLC) were excluded unless complete remission was achieved at least 2 years prior to enrollment and no further treatment was required during the study period (the following conditions are not limited: non-melanoma skin cancer) , bladder carcinoma in situ, gastric carcinoma in situ, colonic carcinoma in situ, endometrial carcinoma in situ, cervical carcinoma in situ/dysplasia, melanoma carcinoma in situ or breast carcinoma in situ)
• Hematopoietic stimulating factors were received within 1 week prior to the first dose of the study drug, such as granulocyte colony-stimulating factor (G-CSF) and erythropoietin.
• HIV antibody or Treponema pallidum antibody test results are positive.
• If HBsAg or HBcAb is positive, hepatitis B virus(HBV) DNA should be tested. Patients should be excluded if the measurement is above the upper limit of the normal range. If HCV antibody is positive, hepatitis C virus(HCV) DNA should be tested. Patients should be excluded if the measurement is above the upper limit of the normal range.
• Those known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and their components; those known to be allergic to CM082 and any of its excipients.
• A large amount of pleural or ascites with clinical symptoms and requiring symptomatic treatment.
• Active lung disease (eg, interstitial pneumonia, pneumonia, obstructive pulmonary disease, asthma) or a history of active tuberculosis.
• Have any clinical problems out of control, including but not limited to:
• Persistent or active (severe) infection;
• Hypertension that is not effectively controlled (blood pressure lasts greater than 150/90mmHg);
• Diabetes that is not effectively controlled;
• Heart disease, defined as grade III/IV congestive heart failure or heart block defined by the New York Heart Association

Sponsors & Collaborators

• AnewPharma: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

vorolanib; toripalimab

Condition Hierarchy (Ancestors)

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

Study Officials

• Zhao Jun, M.D

  Peking University Cancer Hospital & Institute

  STUDY CHAIR

Central Study Contacts

Zhao Jun, M.D

CONTACT

010-88140650; ohjerry@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 21, 2019
• Study Start: April 2, 2019
• Primary Completion: February 1, 2021
• Study Completion: September 1, 2021
• Last Updated: July 9, 2020

Record last verified: 2020-07

Locations

CN (1)