Fluzoparib Combined With Camrelizumab for Maintenance Treatment of Locally Advanced Non-small Cell Lung Cancer

NCT04828395 | Unknown Phase 2

• 1 other identifier: E20210094A
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Fluzoparib combined with Camrelizumab for maintenance treatment of locally advanced non-small cell lung cancer after concurrent radiotherapy and chemotherapy

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review

  PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.

  2 year

Secondary Outcomes (4)

• Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review

  2 year

• Disease control rate (DCR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review

  2 year

• Overall Survival (OS)

  2 year

• Safety of drug application

  2 year

Interventions

Camrelizumab BIOLOGICAL

200mg iv Q3W

Fluzoparib DRUG

150mg bid

Cisplatin，Pemetrexed DRUG

Cisplatin 75mg/m2 IV and Pemetrexed 500mg/m2 IV Q3W (Day 1 of each cycle of cycles 1-3) (non-squamous cell carcinoma only)

Cisplatin，Etoposide DRUG

Cisplatin 50mg/m2 IV (the 1st and 8th days of the 1st cycle and the 2nd cycle; the 8th and 15th days of the 3rd cycle); Etoposide 50mg/m2 IV (the 1st cycle And the 1st to the 5th day of the 2nd cycle; the 8th to the 12th day of the 3rd cycle).

Carboplatin, Albumin Paclitaxel DRUG

Carboplatin AUC=6, Albumin Paclitaxel 100mg/m2 IV; Days 1, 8 and 15 of cycles 1, 2, and 3.

Radiotherapy RADIATION

60 Gy (total 6 weeks)

Eligibility Criteria

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

You may qualify if:

• Subject type and disease characteristics
• Suffer from NSCLC diagnosed by pathology (histology or cytology).
• Have stage IIIA, IIIB, or IIIC NSCLC diagnosed according to the 8th edition of the American Joint Committee on Cancer.
• It is confirmed and recorded by the multidisciplinary oncology committee or the treating physician and the thoracic surgeon to have stage III NSCLC that cannot accept radical surgery.
• In whole-body fluorodeoxyglucose (FDG)-PET or FDG-PET/CT and diagnostic-quality CT or MRI scans of the chest, abdomen, pelvis, and brain, there is no evidence of metastatic disease as stage IV NSCLC.

You may not qualify if:

• Suffer from a measurable disease defined by RECIST 1.1, and at least one lesion is suitable as a target lesion (determined by the investigator/imaging review of the local research center).
• No previous treatment (chemotherapy, targeted therapy or radiotherapy) for stage III NSCLC.
• A tumor tissue sample (tissue biopsy \[thick needle biopsy, excision biopsy, or excision biopsy\]) is provided. The tissue block of FFPE is better than the slice. The newly obtained tumor sample is better than archived tissue and should be obtained before chest imaging at screening.
• Note: If an unstained section is submitted, the new section must be submitted to the testing laboratory within 14 days of preparation.
• The ECOG performance status assessed within 7 days before the first dose of the study intervention is 0 or 1 point.
• The life expectancy is at least 6 months.
• Sufficient PFT is defined as FEV1\> 50% of predicted normal expiratory volume and lung carbon monoxide diffusion volume (DLCO)\> 40% of predicted normal value. For subjects without DLCO measurement values, if the measured pulse oximetry (O2 saturation) in indoor air is ≥90%, it will be deemed to have sufficient oxygen transmission.
• Have adequate organ functions, as defined in Table 1; all laboratory tests during the screening period should be completed 10 days before the start of the research intervention.
• ANC ≥ 1.5×109/L;
• HB ≥ 90 g/L;
• PLT ≥ 100×109/L;
• The biochemical inspection must meet the following standards:
• TBIL ≤ 1.5ULN;
• ALT, AST≤ 2.5 ULN;
• Serum creatinine sCr≤1.5ULN, endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula);

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Liu ningbo

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

camrelizumab; fluzoparib; PE regimen; Carboplatin; Radiotherapy

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)

Coordination Complexes; Organic Chemicals; Therapeutics

Central Study Contacts

Liu ningbo, PhD

CONTACT

15602036608; liuningbo@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: April 2, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2025
• Last Updated: May 11, 2021

Record last verified: 2021-03

Locations

CN (1)