Phase II Study of the Combination of CM082 With JS001 in Patients With Advanced NSCLC.
|ClinicalTrials.gov Identifier: NCT03848611|
Recruitment Status : Not yet recruiting
First Posted : February 21, 2019
Last Update Posted : February 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Drug: CM082 plus JS001||Phase 2|
The study is divided into the following five stages——screening period, treatment period, end of treatment / withdrawal treatment,follow-up after treatment, survival follow-up.
Screening period Subjects should be informed and signed an informed consent form prior to screening assessment. Screening should be performed within 28 days prior to dosing. After the investigator confirms compliance with the inclusion criteria and does not meet the exclusion criteria, the subject may be enrolled in the study drug.
Treatment period At this stage the subject will be treated with CM082 and JS001 until disease progression, intolerable toxicity, the investigator or subject decides to quit,is lost to follow-up, begins using other anti-tumor treatments or dies.
During the trial, subjects received a safety assessment every 4 weeks; tumor assessments were performed 6 weeks after the first visit and every 8 weeks after the first tumor assessment, Tumor progression will be evaluated simultaneously according to RECIST criteria and iRECIST criteria. Subjects identified as iCPD (iRECIST criteria) should discontinue treatment.
End of treatment / withdrawal treatment EOT visit evaluation should be performed as soon as possible after the subject has discontinued the test drug. Anyone who discontinues treatment or withdraws from treatment for reasons other than progression of the disease should perform a safety assessment as soon as possible, while continuing to perform a tumor assessment at the same frequency as the treatment period until disease progression or initiation of other anti-tumor treatments. However, subjects who have terminated treatment due to disease progression need only undergo a safety assessment and no longer have a tumor assessment. If the subject terminates treatment due to toxicity or other reasons at the last visit and does not continue taking the test drug afterwards, the visit is considered to be the end of treatment/exit treatment visit.
Follow-up after treatment For subjects who completed the trial or withdrew their informed consent, all AEs and concomitant medications must be recorded up to 30 days after the last dose of the trial, and all new AEs were issued within 30 days of the last trial dose. For subjects who started using other anti-tumor therapies, AEs that were not severe and that the investigator considered unrelated to the test drug were no longer recorded.
Survival follow-up Subjects with disease progression or other anti-tumor treatments will no longer undergo safety and tumor assessment, but continue to collect data on overall survival and follow-up treatment at telephone follow-up every 12 weeks until the patient dies or loses visit.
Note: Patients who discontinue treatment due to disease progression (except for patients withdrawing informed consent, loss of follow-up, death) should continue to follow the tumor assessments according to the original frequency (no safety assessment) ). Once disease progression has occurred or other anti-tumor drugs have been used, a telephone survival follow-up is performed every 12 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of the Combination of CM082 With JS001 in Patients With Advanced NSCLC.|
|Estimated Study Start Date :||February 2019|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2021|
Experimental: CM082 plus JS001
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
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.
Other Name: Vorolanib plus Toripalimab Injection
- Objective Response Rate according to RECIST 1.1 [ Time Frame: 12 months ]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.
- Disease Control Rate according to RECIST 1.1 and iRECIST [ Time Frame: 12 months ]The proportion of patients with complete remission (CR),partial remission (PR) and stable diseasein(SD) all patients.Disease progression will be evaluated according to RECIST 1.1 and iRECIST.
- Duration of Response according to RECIST 1.1 and iRECIST [ Time Frame: 12 months ]The time interval between the first time of being evaluated as complete response (CR) or partial response (PR) and the first time of being evaluated as progressed disease(PD).Disease progression will be evaluated according to RECIST 1.1 and iRECIST.
- Time to Response to RECIST 1.1 and iRECIST [ Time Frame: 12 months ]ime from randomization to complete response (CR) or partial response (PR).Disease progression will be evaluated according to RECIST 1.1 and iRECIST
- Progression-free survival [ Time Frame: 12 months ]The internal between the date of randomization and the date of disease progression, unaccepted toxicity, or death.
- Overall survival [ Time Frame: 36 months ]The internal between the date of randomization and the date of death.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848611
|Contact: Zhao Jun, M.Dfirstname.lastname@example.org|
|Study Chair:||Zhao Jun, M.D||Beijing Cancer Hospital|