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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Small Cell Lung Cancer
• Intervention / Treatment: Drug: temozolomide; Drug: Fluzoparib; Biological: SHR-1316

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610015
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects who have recurrent small cell lung cancer confirmed by histology or cytology.
2. Failed one prior line of platinum-based chemotherapy.
3. 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) ;
4. Freshly acquired samples or archived specimens within 12 months before randomization must be provided.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
6. Participant must have a life expectancy ≥ 12 weeks.

Exclusion Criteria:

1. Active or untreated central nervous system (CNS) metastases.
2. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
3. History of autoimmune disease.
4. Positive test result for human immunodeficiency virus (HIV).
5. Active hepatitis B or hepatitis C.
6. Severe infections.
7. 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.
8. Significant cardiovascular disease.
9. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental A (part 1) : Fluzoparib + temozolomide	Drug: temozolomide; Given PO; Drug: Fluzoparib; Given PO
EXPERIMENTAL: Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316	Drug: temozolomide; Given PO; Drug: Fluzoparib; Given PO; Biological: SHR-1316; Given injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points.	up to approximately 2 Years
Duration of Response	Duration of Response, determined using RECIST v1.1 criteria.	Up to approximately 2 Years
Disease Control Rate	Disease Control Rate, determined using RECIST v1.1 criteria.	Up to approximately 2 Years
Time to Response	Time to Response, defined as the time from randomization to PR or CR.	Up to approximately 2 Years
Overall survival and overall survival at 6 months, 9months and 12 months	Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up.	Up to approximately 1 Year

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 11, 2020
• Primary Completion (ACTUAL): January 15, 2022
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (ACTUAL): May 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: SHR-3162-Ib-115

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No