Pamiparib for Consolidation Treatment of Unprogressed LS-SCLC After Concurrent Chemoradiotherapy (NCT05483543) | Clinical Trial Compass
UnknownPhase 2
Pamiparib for Consolidation Treatment of Unprogressed LS-SCLC After Concurrent Chemoradiotherapy
China44 participantsStarted 2022-06-20
Plain-language summary
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) .
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry, had good compliance and cooperated with the follow-up.
* Age at least 18 years
* Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, American Joint Committee on Cancer \[AJCC\] staging, 8th edition \[Ed.\]), within 60 days prior to registration
* Patients must have had measurable disease (per Response Evaluation Criteria in Solid Tumors \[RECIST\], version 1.1) prior to the required cycle of cCRT
* Patients must be free of disease progression and not be able to receive other antitumor therapy within 6 weeks of completion of cCRT
* Patients must submit archived or freshly biopsied tumor tissue (formalin-fixed, paraffin-embedded tissue block or approximately 15 unstained sections \[must have \>8 sections\]) along with the relevant pathology report.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 30 days prior to registration
* Patient life expectancy must be \>12 weeks
Exclusion Criteria:
* Mixed SCLC or NSCLC confirmed by histology
* Previous tumor resection for LS-SCLC
* Any patient treatable by surgery or stereotactic body radiation therapy/stereotactic ablative radiation therapy should be excluded
* Expected to receive any other form of anti-tumor therapy during the study period
* Previous treatment with PARP inhibitor drugsā¦
What they're measuring
1
1-year Progression Free Survival Rate
Timeframe: One year after the start of intervention