CM082 and JS001 in Patients With Advanced Small-cell Lung Cancer (SCLC)

NCT03904719 | Unknown Phase 2

• 1 other identifier: CM082-CA-II-203
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This study was a single-arm, multi-center, phase II study, which is aimed to evaluate the efficacy and safety of CM082 combined with JS001 as the second-line treatment of advanced small cell lung cancer. Eligible patients will receive CM082 tablets 150mg once daily orally in combination with JS001 (240mg, intravenously) every 21 days. Treatment continues until disease progresses , intolerable toxicity, or withdraw.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  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.

  6 months

Secondary Outcomes (5)

• Progression-free survival

  12 months

• Overall survival

  36 months

• Disease Control Rate

  6 months

• Duration of Response

  12 months

• Time to response

  12 months

Study Arms (1)

CM082 plus JS001

EXPERIMENTAL

CM082 tablets 150mg is orally given once daily in a 28-day cycle, combinational JS001 240mg was given intravenously on day 1 once every 21 days.

Drug: CM082 plus JS001

Interventions

CM082 plus JS001 DRUG

CM082: 150mg once a day orally (taken within half an hour after breakfast) JS001: An intravenous infusion of a solution having a concentration of 1-3mg/ml was prepared with 0.9% physiological saline, and administered once every three 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, Toripalimab

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 recurrent, inoperable, metastatic SCLC (stage III/IV period);
• Progressive disease after prior standard systemic treatment;
• Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1;
• Life expectancy of at least 12 weeks;
• At least one measurable lesion according to the RECIST 1.1;
• Adequate organ functions;
• Negative serum pregnancy test results within 7 days prior to the first dose of the study drug;
• Patients willing to obey the schedule for study and follow-up procedures;
• Patients who can understand the nature of the study and sign voluntarily the informed consent.

You may not qualify if:

• Patients who have previously received treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or VEGFR TKI therapy (sunitinib, sorafenib, pizopren, axitinib, bevacizumab, remomituzumab, nidanib, vandetanib, etc), or CTLA-4 inhibitor (Ipilimumab, etc).
• Patients who are presently receiving other systematic antitumor therapies.
• Patients who developed other malignancies (not including cured basal cell tumor of skin, endoscopically resected early gastrointestinal tract \[GI\] tumor, and cervical carcinoma in situ) except lung cancer in the past 2 years.
• Patients receiving a major surgery or immunotherapy in the past 4 weeks prior to the first dose; and patients receiving a radiotherapy within 2 weeks prior to the first dose.
• Patients with brain metastases or meningeal metastases.
• Have received hematopoietic stimulating factors within 1 week prior to the first dose of the study drug.
• Patients who previously received stem cell transplantation or organ transplantation.
• Patients with swallowing dysfunction, active gastrointestinal disease, or other disorders that may influence significantly absorption, distribution, metabolism, or excretion of CM082.
• Patients with active hepatitis B, hepatitis C virus antibody positive , HIV antibodies, or treponema pallidum antibody positive.
• Patients with a prior history of interstitial lung disease, history of drug-induced interstitial lung disease, history of radiation pneumonia requiring a steroid therapy, or any clinical indications for active interstitial lung disease.
• Patients who are known to be allergic to JS001 or CM082 or any excipients of the study drugs.
• Patients receiving in the past 14 days or requiring concurrently the following drugs during treatment: Drugs that may result in a risk for QTc prolongation and/or torsades de pointes; or CYP3A potent inhibitors or potent inducers.
• Patients with other severe, acute or chronic medical conditions (including incontrollable diabetes mellitus, or medical disease or mental disease, or laboratory test abnormality) that may increase study-related risk or may interfere with interpretation of the research results, in the viewpoints of the investigator.
• Patients with other conditions that not suitable to participate in this study, as considered by the investigator.

Sponsors & Collaborators

• AnewPharma: lead

Study Sites (2)

National Cancer Center/Cancer Hospital

Beijing, China

NOT YET RECRUITING

The First Hospital of China Medical University

Shenyang, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

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

• Yuankai Shi, MD

  National Cancer Center/Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Yuankai Shi, MD

CONTACT

010-67781331; syuankai@cicams.ac.cn

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: April 4, 2019
• First Posted: April 5, 2019
• Study Start: September 18, 2019
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: July 9, 2020

Record last verified: 2020-07

Locations

CN (2)