Trials / Unknown
UnknownNCT03904719
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- AnewPharma · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-09-18
- Primary completion
- 2021-06-30
- Completion
- 2021-12-31
- First posted
- 2019-04-05
- Last updated
- 2020-07-09
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03904719. Inclusion in this directory is not an endorsement.