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

Phase 2

Recruiting

• Conditions: Limited Stage Small Cell Lung Cancer
• Interventions: Drug: Pamiparib

• Registration Number: NCT05483543
• Lead Sponsor: Fudan University

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) .

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-20
• Status Verified: 2022-07
• Study First Submitted: 2022-07-29
• Study First Submitted QC: 2022-07-29
• Last Update Submitted: 2022-07-29
• Study First Posted: 2022-08-02
• Last Update Posted: 2022-08-02
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pamiparib monoagent	Pamiparib	Drug: Pamiparib 40mg bid orally

Primary Outcome Measures

Name	Time	Method
1-year Progression Free Survival Rate	One year after the start of intervention	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

Name	Time	Method
Progression Free Survival	Two years	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	Two years	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	Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first	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.

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China