Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study

Summary

This phase II trial tests how well biomarker tests on patients tumor tissue works in selecting personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). Biomarker tests look for certain features in cancer cells that may give doctors more information about what is driving cancer and how to treat it. Based on the biomarker test results, study doctors can determine the subtype of ES-SCLC that study treatments can target. This study also tests different types of maintenance treatment for ES-SCLC with drugs durvalumab, saruparib, ceralasertib or monalizumab. Maintenance treatment is given after initial treatment and is given to help keep the cancer under control and prevent it from getting worse. Immunotherapy with monoclonal antibodies, such as durvalumab and monalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Saruparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Ceralasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for tumor cell growth. Giving biomarker selected personalized maintenance treatment with durvalumab, saruparib, ceralasertib or monalizumab may work better in treating patients with ES-SCLC.

Conditions

• Extensive Stage Lung Small Cell Carcinoma
• Lung Small Cell Carcinoma, A Subtype
• Lung Small Cell Carcinoma, I Subtype
• Lung Small Cell Carcinoma, N Subtype
• Lung Small Cell Carcinoma, P Subtype

Interventions

PROCEDURE

Biospecimen Collection

Undergo tissue and blood sample collection

DRUG

Ceralasertib

Given PO

PROCEDURE

Computed Tomography

Undergo CT scan

BIOLOGICAL

Durvalumab

Given IV

DRUG

Etoposide

Given etoposide

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Monalizumab

Given IV

DRUG

Platinum Compound

Given platinum compound

PROCEDURE

Positron Emission Tomography

Undergo PET/CT scan

DRUG

Saruparib

Given PO

RADIATION

Thoracic Radiation Therapy

Undergo thoracic radiation

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• SWOG Cancer Research Network

  lead NETWORK

Principal Investigators

• Anne C Chiang · SWOG Cancer Research Network

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-06

Primary Completion

2028-12-31

Completion

2029-12-31

FDA Drug

Yes

Countries

• United States

Study Locations