Small Cell Lung CancerPhase 2NCT03904719
CM082 and JS001 in Patients With Advanced Small-cell Lung Cancer (SCLC)
A Phase 2 study testing CM082 plus JS001 in people with Small Cell Lung Cancer, run by AnewPharma at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- CM082 plus JS001
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 18 Sep 2019to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
National Cancer Center/Cancer Hospital
Beijing
Yuankai Shi, 010-67781331, syuankai@cicams.ac.cn
- Recruiting
The First Hospital of China Medical University
Shenyang
Yunpeng Liu, cmu_trial@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Small Cell Lung Cancer
- Being tested
- CM082 plus JS001
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM082 plus JS001Drug
Also called Vorolanib, Toripalimab
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CM082 plus JS001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 12 months
Overall survival
The internal between the date of randomization and the date of death
Measured: 36 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.
Measured: 6 months
Duration of Response
The time between patients's first time to complete or partial remission to disease progression.
Measured: 12 months
Time to response
The internal between the date of enrollment and the date of documented tumor response
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start18 Sep 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AnewPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuankai Shi, MD, Study chair, National Cancer Center/Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904719
- Sponsor's protocol ID
- CM082-CA-II-203
- Status last verified
- Jul 2020
- First submitted
- 4 Apr 2019
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of CM082 With JS001 in Patients With Advanced Small-cell Lung Cancer (SCLC) Who Progressed on First-line Treatment: a Phase II Study
- ClinicalTrials.gov ID
- NCT03904719
- Acronym / sponsor ID
- CM082-CA-II-203
- Conditions
- Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AnewPharmaIndustry (pharma, biotech, devices)
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CM082 plus JS001 | Experimental | Drug: CM082 plus JS001CM082 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CM082 plus JS001Also: Vorolanib, ToripalimabCM082: 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. | Drug | CM082 plus JS001 |
Primary outcome
Objective Response Rate
Time frame: 6 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.
5 secondary outcomes
Progression-free survival
Time frame: 12 months
Overall survival
Time frame: 36 months
Disease Control Rate
Time frame: 6 months
Duration of Response
Time frame: 12 months
Time to response
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuankai Shi, MD study chair
National Cancer Center/Cancer Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CM082 plus JS001 in people with Small Cell Lung Cancer, run by AnewPharma at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuankai Shi, MD (010-67781331, syuankai@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.