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This study is a prospective, single-arm, phase II clinical trial, with 1-year PFS as the endpoint, to evaluate the efficacy and associated toxicity of Pamiparib as single-agent consolidation treatment in patients with limited-stage small cell lung cancer(LS-SCLC) patients who have not progressed following platinum-based concurrent chemoradiotherapy(cCRT) .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pamiparib monoagent | Experimental | Drug: Pamiparib 40mg bid orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pamiparib | Drug | Patients will receive Pamiparib 40 mg bid every 3 weeks after cCRT up to 1 year or disease progression according to RECIST v1.1 occur. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-year Progression Free Survival Rate | One-year PFS rate was define as the percentage of patients who did not experience disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death due to any cause within 1 year from the date cCRT treatment ended. | One year after the start of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Progression-free survival according to RECIST v1.1 from date of cCRT treatment ended until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months. For patients whose disease did not progress, PFS was evaluated by censoring patients at their most recent imaging. | Two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengfei Zhu, MD | Contact | +86-18017312901 | fuscczzf@163.com | |
| Xi Yang, MD | Contact | 18918768091 |
| Name | Affiliation | Role |
|---|---|---|
| Zhengfei Zhu, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38610031 | Derived | Mao J, Ni J, Chu L, Chu X, Xu D, Yang X, Zhu Z. Pamiparib as consolidation treatment after concurrent chemoradiotherapy of limited-stage small cell lung cancer: a single-arm, open-label phase 2 trial. Radiat Oncol. 2024 Apr 12;19(1):47. doi: 10.1186/s13014-024-02437-2. |
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| ID | Term |
|---|---|
| C000707927 | pamiparib |
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| Overall Survival | Overall survival from date of cCRT treatment ended until the date of end of treatment visit or date of death from any cause, whichever came first, assessed up to 24 months. Participants still alive at the time of data analysis will be censored at the date of last follow-up. | Two years |
| AEs/SAEs | The level of AEs defined by NCI-CTCAE v5.0. Safety assessments will be assessed and documented after initiation of study drug, regardless of relationship to study drug. | Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first |
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|