Radiotherapy Combined With Niraparib and Toripalimab in Patients With Recurrent Small Cell Lung Cancer (CREATE): A Open-label, Single-arm, Phase II Study

Wuhan University0 sites57 target enrollmentJune 2022

ConditionsRecurrent Small Cell Lung Cancer

InterventionsSBRT Toripalimab Niraparib

DrugsToripalimab Niraparib

Overview

Phase: Phase 2
Intervention: SBRT
Conditions: Recurrent Small Cell Lung Cancer
Sponsor: Wuhan University
Enrollment: 57
Primary Endpoint: ORR (Objective response rate)
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

June 2022

End Date

December 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Wuhan University

Responsible Party

Principal Investigator

Conghua Xie,MD,PhD

Ph.D

Wuhan University

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed small cell lung cancer.
•Age ≥ 18 years.
•Previously received 1-2 lines of treatment (including 1 systemic platinum-containing treatment), and responded to the first platinum-containing treatment (response is defined as CR, PR or SD).
•At least 1 measurable target lesion based on RECIST 1.
•Allow previous anti-PD-L1 antibody treatment, enrolled patients ≤ 30% of the total enrolled number.
•Life expectancy ≥ 12 weeks.
•Eastern Cooperative Oncology Group (ECOG) Performance Status score 0-
•Adequate hematologic function, hepatic function and renal function
•Female who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must be willing to use an adequate method of contraception.
•Male subjects of childbearing potential must agree to use an adequate method of contraception (failure rate \< 1% per year) - Contraception, starting with the first dose of study therapy through 6 months after the last dose of study therapy.

Exclusion Criteria

•People who are known to be allergic to Niraparib or to active or inactive ingredients of drugs with similar chemical structure to Niraparib.
•People who are known to be allergic to Toripalimab or to active or inactive ingredients of drugs with similar chemical structure to Toripalimab.
•Symptomatic and uncontrolled cerebral or leptomeningeal metastasis. No imaging scan is required to confirm no brain metastases; subjects with spinal cord compression may be considered for inclusion if they have received targeted treatment and evidence of clinical stability of the disease for at least 28 days (patients with controlled CNS metastases must have received treatment such as radiotherapy or chemotherapy at least one month before entering the study; subjects should not develop new symptoms related to central nervous system lesions or symptoms indicating disease progression, and subjects either take stable doses of hormones or do not need to take hormones).
•Chemotherapy or major surgery was performed within 3 weeks prior to the study or any surgical effect that has not been recovered after surgery.
•Radiotherapy for target lesions within 4 weeks of initiating study drugs, or palliative radiotherapy for \>20% bone marrow within 1 week prior to enrollment.
•Patients with high risk of massive hemoptysis (such as uncured bronchiectasis, pulmonary tuberculosis).
•Malignancies other than small cell lung cancer within 5 years prior to enrollment (except for radically treated cervical cancer in situ, basal cell carcinoma and superficial bladder tumor).
•Patients with previously or currently diagnosed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
•Severe or uncontrolled conditions or diseases, including but not limited to:
•Uncontrollable nausea and vomiting, inability to swallow study drugs, or any gastrointestinal disease that could affect drug absorption or metabolism.

Arms & Interventions

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

Intervention: SBRT

SBRT combined with Niraparib and Toripalimab

Intervention: Toripalimab

SBRT combined with Niraparib and Toripalimab

Intervention: Niraparib

Outcomes

Primary Outcomes

ORR (Objective response rate)

Time Frame: Approximately 2 years

Objective response rate (ORR) evaluated by investigators and BIRC based on RECIST1.1

Secondary Outcomes

Intrathoracic and extrathoracic recurrence rate(Approximately 2 years)
DCR (Disease of Response)(Approximately 2 years)
The incidence of adverse events (AEs) as a measure of safety(Approximately 2 years)
PFS (Progression Free Survival)(Approximately 2 years)
DOR (Duration of Response)(Approximately 2 years)
PFS (Progression Free Survival) Rate(Approximately 1year)
Overall suvival (OS)(Approximately 2 years)
OS (Overall Survival) rate(Approximately 1 years)