The Efficacy and Safety of Radiotherapy Plus Niraparib and Toripalimab in Patients With Recurrent Small Cell Lung Cancer

Sponsor
Wuhan University
Study ID
NCT05162196
Phase
PHASE2
Status
Unknown

Conditions

  • Recurrent Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SBRT — RADIATION
    24Gy/3F
  • Toripalimab — DRUG
    Toripalimab 240mg, ivgtt, d1, q3w.
  • Niraparib — DRUG
    200mg qd

Study Details

This is a prospective, multicenter, open-label study to observe the efficacy and safety of combination with radiotherapy, niraparib and toripalimab in patients With recurrent small cell lung cancer(SCLC).

Key Dates

Start date
Jun 30, 2022
Status verified
Apr 2022
Primary completion
Jun 30, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
57 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SBRT combined with Niraparib and Toripalimab
    Induction therapy (cyc1: D1-D28): Niraparib 200mg QD + SBRT 8Gy✖️3 QD, D4-D6 + Toripalimab 240mg iv drip D7 Maintenance (cyc2+): Niraparib 200mg QD, D1-D21 + Toripalimab 240mg iv drip D1, until disease progression or intolerable toxicity

Primary Outcome Measure

ORR (Objective response rate) [ Time Frame: Approximately 2 years ]

Central Contacts

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