A Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer

NCT04400188 | Completed Phase 1

• 1 other identifier: SHR-3162-Ib-115
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is a multicentre phase Ⅰb/Ⅱ Study to evaluate the efficacy and safety of the combination of Fluzoparib (SHR-3162) and temozolomide with or without SHR-1316 in small cell lung cancer

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• Phase Ⅰb: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period.

  At the end of Cycle1 (each cycle is 21 days )

• Phase Ⅰb: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of Fluzoparib and temozolomide with or without SHR-1316.

  Up to approximately 2 Years

• Phase Ⅱ: Progression Free Survival (PFS) at four months.

  Up to approximately 2 Years

• Phase Ⅱ: Progression Free Survival (PFS) as Assessed by the Investigator according to RECIST v1.1.

  Progression Free Survival, defined as the time from randomization to first assessment of disease progression or death, whichever is earlier.

  Up to approximately 2 Years

Secondary Outcomes (5)

• Objective Response Rate

  up to approximately 2 Years

• Duration of Response

  Up to approximately 2 Years

• Disease Control Rate

  Up to approximately 2 Years

• Time to Response

  Up to approximately 2 Years

• Overall survival and overall survival at 6 months, 9months and 12 months

  Up to approximately 1 Year

Study Arms (2)

Experimental A (part 1) : Fluzoparib + temozolomide

EXPERIMENTAL

Drug: Fluzoparib; Drug: temozolomide

Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316

EXPERIMENTAL

Drug: Fluzoparib; Drug: temozolomide; Biological: SHR-1316

Interventions

Fluzoparib DRUG

Given PO

Experimental A (part 1) : Fluzoparib + temozolomide; Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316

temozolomide DRUG

Given PO

Experimental A (part 1) : Fluzoparib + temozolomide; Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316

SHR-1316 BIOLOGICAL

Given injection

Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have recurrent small cell lung cancer confirmed by histology or cytology.
• Failed one prior line of platinum-based chemotherapy.
• Subjects must have measurable disease, at least one lesion, by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria (within 28 days prior to administration of study treatment) ;
• Freshly acquired samples or archived specimens within 12 months before randomization must be provided.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Participant must have a life expectancy ≥ 12 weeks.

You may not qualify if:

• Active or untreated central nervous system (CNS) metastases.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
• History of autoimmune disease.
• Positive test result for human immunodeficiency virus (HIV).
• Active hepatitis B or hepatitis C.
• Severe infections.
• Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment.
• Significant cardiovascular disease.
• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610015, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

fluzoparib; Temozolomide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• You Lu, MD

  West China Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Fluzoparib (SHR-3162) combined with temozolomide or Fluzoparib (SHR-3162) and temozolomide with SHR-1316

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 22, 2020
• Study Start: June 11, 2020
• Primary Completion: January 15, 2022
• Study Completion: January 15, 2022
• Last Updated: June 29, 2025

Record last verified: 2025-06

Locations

CN (1)