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Status unknownNCT05483543Updated Aug 2, 2022

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

A Phase 2 interventional study of Pamiparib in Limited Stage Small Cell Lung Cancer, sponsored by Fudan University. Status unknown at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
44
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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) .

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Conditions studied

  • Limited Stage Small Cell Lung Cancer
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In context

Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

Browse Fudan University studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Pamiparib monoagent

    Drug: Pamiparib 40mg bid orally

    Drug: Pamiparib

Interventions

  • DrugPamiparib

    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

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What researchers measure

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.

    Time frame: One year after the start of intervention

Secondary outcomes

  1. 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.

    Time frame: Two years

  2. 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.

    Time frame: Two years

  3. 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.

    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

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Study locations

2 of 2 sites recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality 200032, China
    Recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality 200032, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 38610031 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2022 (actual). Primary completion is estimated for Dec 2024, 30 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 29, 2022
First posted
Aug 2, 2022
StartActual
Jun 20, 2022
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2024
Last update
Aug 2, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05483543
Lead sponsor
Fudan University
Responsible party
Zhengfei Zhu (Fudan University, Fudan University) — Principal investigator
First posted
Aug 2, 2022
Start date
Jun 20, 2022
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Aug 2, 2022

Study contacts

Zhengfei Zhu, MD
Contact
fuscczzf@163.com
+86-18017312901
Xi Yang, MD
Contact
18918768091
Zhengfei Zhu, MD
principal investigator · Fudan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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