PD1 and PARP for Maintenance Therapy in NSLLC

NCT05392686 | Unknown Phase 2

• 1 other identifier: E20220325
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

PARP inhibitor and PD1 in lung squamous cell carcinoma The current study will compare PD1 plus maintenance PARP for the treatment of squamous NSCLC. The study's 2 primary hypotheses are: respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR). Overall survival (OS).

Conditions

Lung Cancer

Keywords

pd1; PARP

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  Progression-free Survival is the time from the date of randomization until either documented disease progression or death due to any cause, whichever occurs first.

  Up to approximately 2 years

Study Arms (1)

Experimental: PD1 + PARP

EXPERIMENTAL

For the Induction Phase, participants receive 4 cycles: PD1 200 mg, intravenous (IV) on Day 1 of each 21-day cycle PLUS carboplatin PLUS a taxane (either paclitaxel or nab-paclitaxel) for 4 cycles (21-day cycles). If the participant has a complete or partial response or stable disease to induction therapy, the participant to maintenance therapy. For the Maintenance Phase, participants receive PD1 IV on Day 1 of each 21-day for up to 31 cycles PLUS maintenance oral PARP 100 mg twice daily. Until centrally verified progressive disease, physician decision or intolerable toxicity.

Drug: PD-1 inhibitor; Drug: PARP inhibitor

Interventions

PD-1 inhibitor DRUG

Tirelizumab

Experimental: PD1 + PARP

PARP inhibitor DRUG

Fluzopari capsule

Experimental: PD1 + PARP

Eligibility Criteria

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

You may qualify if:

• NSCLC confirmed by pathology (histology or cytology)
• \. First line treatment of patients with immune combined with chemotherapy into immune maintenance treatment;
• \. 18-75 years old, both male and female;
• \. There are stage IIIA, IIIB or IIIc NSCLC diagnosed according to the 8th edition of the American Joint Committee on cancer.
• \. Stage III NSCLC that cannot undergo radical surgery was confirmed and recorded by the multidisciplinary tumor committee or the treating physician in consultation with the thoracic surgeon.
• \. In the whole body fluorodeoxyglucose (FDG) - pet or FDG-PET / CT and diagnostic quality CT or MRI scans of the chest, abdomen, pelvis and brain, there was no evidence of metastatic disease as stage IV NSCLC.

You may not qualify if:

• \. Having a measurable disease as defined in RECIST 1.1, at least one lesion is suitable as a target lesion (determined by the investigator / imaging review of the local research center).
• \. No more than 28 days before the first study, CT or MRI scan, at least one previous target lesion without radiotherapy (recistv1.1).
• \. No previous treatment (chemotherapy, targeted therapy or radiotherapy) for stage III NSCLC.
• \. ECoG physical fitness status is 0 or 2 points.
• \. Life expectancy is at least 12 weeks.
• \. No antiangiogenic drugs or PARP inhibitors have been used in previous treatment;
• \. All acute toxic reactions caused by previous anti-tumor treatment or surgery are relieved before the screening period
• (except for hair loss and other toxicity that the researchers believe does not pose a safety risk to the subject).
• \. No blood transfusion and blood products were used within 14 days before the first administration, and G-CSF and other hematopoietic stimulating factors were not used for correction.
• \. Before the first drug study, the laboratory test values meet the following conditions:
• Blood routine:
• White blood cell count (WBC) ≥ 3.0 × 109/L；
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L；
• Platelet (PLT) ≥ 100 × 109/L；
• Hemoglobin content (Hgb) ≥ 9.0 g / dl;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

Immune Checkpoint Inhibitors; Poly(ADP-ribose) Polymerase Inhibitors

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Enzyme Inhibitors

Study Design

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

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 26, 2022
• Study Start: June 20, 2022
• Primary Completion: June 21, 2022
• Study Completion: April 1, 2025
• Last Updated: May 26, 2022

Record last verified: 2022-05

Locations

CN (1)