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

NCT05483543 | Unknown Phase 2

• 1 other identifier: LSSCLCPARPI-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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) .

Conditions

Limited Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  One year after the start of intervention

Secondary Outcomes (3)

• Progression Free Survival

  Two years

• Overall Survival

  Two years

• 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

Study Arms (1)

Pamiparib monoagent

EXPERIMENTAL

Drug: Pamiparib 40mg bid orally

Drug: Pamiparib

Interventions

Pamiparib DRUG

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.

Also known as: BGB-290

Pamiparib monoagent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• Mao J, Ni J, Chu L, Chu X, Xu D, Yang X, Zhu Z. Pamiparib as consolidation treatment after concurrent chemoradiotherapy of limited-stage small cell lung cancer: a single-arm, open-label phase 2 trial. Radiat Oncol. 2024 Apr 12;19(1):47. doi: 10.1186/s13014-024-02437-2.

  PMID: 38610031 DERIVED

MeSH Terms

Interventions

pamiparib

Study Officials

• Zhengfei Zhu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhengfei Zhu, MD

CONTACT

+86-18017312901; fuscczzf@163.com

Xi Yang, MD

CONTACT

18918768091

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fudan University

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 2, 2022
• Study Start: June 20, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 2, 2022

Record last verified: 2022-07

Locations

CN (2)