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Pamiparib for Consolidation Treatment of Unprogressed LS-SCLC After Concurrent Chemoradiotherapy | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

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

NCT05483543•Fudan University

View on ClinicalTrials.gov

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) .

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

June 20, 2022

Primary Completion Date

December 31, 2024

Completion Date

December 31, 2024

Last Updated

August 2, 2022

Enrollment

ESTIMATED participants

Conditions

Limited Stage Small Cell Lung Cancer

Interventions

Pamiparib

DRUG

Contacts

Zhengfei Zhu, MD

CONTACT

+86-18017312901 fuscczzf@163.com

Xi Yang, MD

CONTACT

18918768091

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

NCT06117774

Limited Stage Small Cell Lung CancerSmall Cell Lung Cancer

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RECRUITINGPHASE2

Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients

NCT05443646

Limited Stage Small Cell Lung Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 2, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients

PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)

Sugemalimab as Consolidation Therapy in Patients With LS-SCLC Following cCRT or sCRT

Efficacy and Safety of Prophylactic Cranial Irradiation Versus MRI Surveillance in Patients With Limited-stage Small Cell Lung Cancer Who Achieved Remission After First-line Chemoradiotherapy

Effect of Trilaciclib in the Prevention of Myelosupression in Subjects With Limited-stage Small Cell Lung Cancer