Pamiparib for Consolidation Treatment of Unprogressed LS-SCLC After Concurrent Chemoradiotherapy

Trial Title: Pamiparib for Consolidation Treatment of Unprogressed LS-SCLC After Concurrent Chemoradiotherapy

NCT ID: NCT05483543

Condition: Limited Stage Small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Pamiparib

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Pamiparib
Description: 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.
Arm group label: Pamiparib monoagent

Other name: BGB-290

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) .

Criteria for eligibility:
Criteria:
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 drugs - Any active malignancy within 2 years prior to enrollment, excluding the specific cancers being studied in this study and locally recurrent cancers that have been cured (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, cervical cancer carcinoma in situ or carcinoma in situ of the breast) - Women who are pregnant, breastfeeding, or planning to become pregnant during the study - Concurrent participation in another therapeutic clinical trial

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Zip: 200032
Country: China

Status: Recruiting

Contact:
Last name: Xi Yang, Phd

Phone: +86 17321296901
Email: ntgeroge@qq.com

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Zip: 200032
Country: China

Status: Recruiting

Contact:
Last name: Zhengfei Zhu, MD

Phone: +86 18017312901
Email: fuscczzf@163.com

Start date: June 20, 2022

Completion date: December 31, 2024

Lead sponsor:
Agency: Fudan University
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05483543