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

NCT05162196 | Unknown Phase 2

• 1 other identifier: CREATE
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Recurrent Small Cell Lung Cancer

Keywords

Radiotherapy; Toripalimab; Niraparib

Outcome Measures

Primary Outcomes (1)

• ORR (Objective response rate)

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

  Approximately 2 years

Secondary Outcomes (8)

• DOR (Duration of Response)

  Approximately 2 years

• DCR (Disease of Response)

  Approximately 2 years

• PFS (Progression Free Survival)

  Approximately 2 years

• PFS (Progression Free Survival) Rate

  Approximately 1year

• Overall suvival (OS)

  Approximately 2 years

Study Arms (1)

SBRT combined with Niraparib and Toripalimab

EXPERIMENTAL

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

Radiation: SBRT; Drug: Toripalimab; Drug: Niraparib

Interventions

SBRT RADIATION

24Gy/3F

SBRT combined with Niraparib and Toripalimab

Toripalimab DRUG

Toripalimab 240mg, ivgtt, d1, q3w.

SBRT combined with Niraparib and Toripalimab

Niraparib DRUG

200mg qd

SBRT combined with Niraparib and Toripalimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.1.
• 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 0-2.
• 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.
• Toxic side effect to any previous chemotherapy has returned to ≤ CTCAE Grade 1 or baseline, or except sensory neuropathy or hair loss with stable symptoms ≤ CTCAE Grade 2.

You may not qualify if:

• 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.
• 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.
• Active virus infections such as human immunodeficiency virus (HIV) (positive HIV antibody), hepatitis B virus (HBV; positive HBsAg-positive status and HBV-DNA ≥10\^3 copy number/mL or ≥500 IU/mL), and hepatitis C virus (HCV; positive anti-HCV antibody and/or positive HCV RNA in combination with clinical judgment).
• Uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or mental disease impairing the participant's ability to give informed consent.
• Known diagnosis of immunodeficiency (except for splenectomy) or other conditions that might predispose participants to a high risk of toxicity, as judged by the investigator.
• Need to use any type of corticosteroids for systemic treatment within 14 days of study medication (\>10mg/day prednisone) or other immunosuppressive drugs; in the absence of active autoimmune diseases, inhaled or topical steroids and Adrenal replacement dose (≤10mg/day prednisone); Allow patients to use topical, intraocular, intra-articular, intranasal and inhaled corticosteroids (small systemic absorption); allow physiological alternative doses of systemic corticosteroids (≤10mg/day prednisone); for prevention (such as contrast agents) Allergy) or short-term corticosteroid therapy for non-autoimmune diseases (such as delayed hypersensitivity caused by contact allergens) is allowed.
• History of bleeding tendency and thrombosis:
• Any bleeding events with CTCAE level 2 occurred within 3 months before screening, or with CTCAE level 3 and above within 6 months before screening

Sponsors & Collaborators

• Wuhan University: lead

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

toripalimab; niraparib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Conghua Xie, MD,PhD

CONTACT

0086-27-67812607; chxie_65@hotmail.com

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: Ph.D

Study Record Dates

• First Submitted: December 4, 2021
• First Posted: December 17, 2021
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share