Back to resultsPamiparib for Consolidation Treatment of Unprogressed LS-SCLC After Concurrent Chemoradiotherapy
Primary Purpose
Limited Stage Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pamiparib
Sponsored by
About this trial
This is an interventional treatment trial for Limited Stage Small Cell Lung Cancer
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
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pamiparib monoagent
Arm Description
Drug: Pamiparib 40mg bid orally
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05483543
Brief Title
Pamiparib for Consolidation Treatment of Unprogressed LS-SCLC After Concurrent Chemoradiotherapy
Official Title
A Prospective, Phase II, Single-arm Study Evaluating the Efficacy and Safety of Pamiparib in Consolidation Therapy for Limited-stage Small Cell Lung Cancer That Has Not Progressed After Concurrent Chemoradiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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) .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Limited Stage Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pamiparib monoagent
Arm Type
Experimental
Arm Description
Drug: Pamiparib 40mg bid orally
Intervention Type
Drug
Intervention Name(s)
Pamiparib
Other Intervention Name(s)
BGB-290
Intervention 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.
Primary Outcome Measure Information:
Title
1-year Progression Free Survival Rate
Description
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.
Time Frame
One year after the start of intervention
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
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.
Time Frame
Two years
Title
Overall Survival
Description
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.
Time Frame
Two years
Title
AEs/SAEs
Description
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.
Time Frame
Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhengfei Zhu, MD
Phone
+86-18017312901
Email
fuscczzf@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xi Yang, MD
Phone
18918768091
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhengfei Zhu, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xi Yang, Phd
Phone
+86 17321296901
Email
ntgeroge@qq.com
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhengfei Zhu, MD
Phone
+86 18017312901
Email
fuscczzf@163.com
12. IPD Sharing Statement
Learn more about this trial
Pamiparib for Consolidation Treatment of Unprogressed LS-SCLC After Concurrent Chemoradiotherapy
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