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

Non-small Cell Lung Cancer Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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 confirmed progressive disease(iCPD) according to iRECIST criteria should discontinue treatment.

End of treatment / withdrawal treatment End of 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 adverse events (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. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

• NCT number: NCT03848611
• Study type: Interventional
• Source: AnewPharma
• Contact: Zhao Jun, M.D
• Phone: 010-88140650
• Email: ohjerry@163.com
• Status: Recruiting
• Phase: Phase 2
• Start date: April 2, 2019
• Completion date: September 2021