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

Combination of CM082 With JS001 in Patients With Advanced Small-cell Lung Cancer (SCLC) Who Progressed on First-line Treatment: a Phase II Study

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.

Study Overview

• Status: Unknown
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: CM082 plus JS001

Detailed Description

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.

The primary endpoint is tumor response per investigator assessment according to response evaluation criteria in solid tumors (recist) version 1.1, secondary endpoints include disease control rate, progression-free survival, overall survival, safety and tolerability. iRECIST is also implemented for tumor response assessment.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Not yet recruiting
    • National Cancer Center/Cancer Hospital
    • Contact: Yuankai Shi; Phone Number: 010-67781331; Email: syuankai@cicams.ac.cn
  • Shenyang, China
    • Recruiting
    • The First Hospital of China Medical University
    • Contact: Yunpeng Liu; Email: cmu_trial@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CM082 plus JS001; 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; 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.; Other Names: Toripalimab; Vorolanib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	The internal between the date of randomization and the date of death	36 months
Progression-free survival	The internal between the date of enrollment and the date of disease progression, unaccepted toxicity, or death according to RECIST 1.1 and iRECIST.	12 months
Disease Control Rate	The proportion of patients with complete remission (CR), partial remission (PR) and stable disease (SD) in all patients. Disease progression will be evaluated according to RECIST 1.1 and iRECIST.	6 months
Duration of Response	The time between patients's first time to complete or partial remission to disease progression.	12 months
Time to response	The internal between the date of enrollment and the date of documented tumor response	12 months

Collaborators and Investigators

• Sponsor: AnewPharma
• Investigators: Study Chair: Yuankai Shi, MD, National Cancer Center/Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2019
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Vorolanib
• Other Study ID Numbers: CM082-CA-II-203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No