Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Pharmaceutical Solutions

All Drugs and Chemicals

Vorolanib

Protein Kinase Inhibitors

Enzyme Inhibitors

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.

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.

CM082 plus JS001

Zhao Jun, M.D

Jun Zhao, PhD

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.

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.

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

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

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.

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.

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 from randomization to complete response (CR) or partial response (PR). Disease progression will be evaluated according to RECIST 1.1 and iRECIST

The internal between the date of randomization and the date of disease progression, unaccepted toxicity, or death.

The internal between the date of randomization and the date of death.

AnewPharma

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Patients who meet the enrollment criteria will receive CM082 tablets 200mg 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.

CM082：200mg 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.

Jun Guo, M.D

This study was a one-arm, single-center, phase II clinical study. Patients who meet the enrollment criteria will receive CM082 tablets 200mg 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.

Study of the Combination of CM082 With JS001 in Patients With Advanced Mucosal Melanoma.

Phase II Clinical Study of CM082 Combined With JS001 in the Treatment of Advanced Mucosal Melanoma.

The proportion of patients with complete remission (CR) and partial remission (PR) in all patients.Disease progression will be evaluated according to Response Evaluation Criteria in Solid Tumors V 1.1.

The proportion of patients with complete remission (CR),partial remission (PR) and stable diseasein(SD) all patients.Disease progression will be evaluated according to Response Evaluation Criteria in Solid Tumors V 1.1 and Immune-related Response Criteria.

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 Response Evaluation Criteria in Solid Tumors V 1.1 and Immune-related Response Criteria.

Time from randomization to complete response (CR) or partial response (PR).Disease progression will be evaluated according to Response Evaluation Criteria in Solid Tumors V 1.1 and Immune-related Response Criteria.

The internal between the date of randomization and the date of disease progression, unaccepted toxicity, or death

The internal between the date of randomization and the date of death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CM082 and JS001 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC).	NCT03848611	Non-small Cell ...	CM082 plus JS00...	18 Years - 75 Years	AnewPharma
CM082 and JS001 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC).	NCT03848611	Non-small Cell ...	CM082 plus JS00...	18 Years - 75 Years	AnewPharma
Study of the Combination of CM082 With JS001 in Patients With Advanced Mucosal Melanoma.	NCT03602547	Mucosal Melanom...	CM082 plus JS00...	18 Years - 75 Years	AnewPharma

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