Cardiovascular Injury and Cardiac Fitness in Locally Advanced Non-Small Cell Lung Cancer Patients Receiving Model Based Personalized Chemoradiation

Phase 1

Recruiting

• Conditions: Stage IIIA Lung Cancer AJCC v8; Stage III Lung Cancer AJCC v8; Stage IIIC Lung Cancer AJCC v8; Locally Advanced Lung Non-Small Cell Carcinoma; Stage IIIB Lung Cancer AJCC v8

• Registration Number: NCT05010109
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

This study assesses cardiovascular injury and cardiac fitness in patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (locally advanced) receiving model based personalized chemoradiation. The goal of this study is to learn more about the risk of developing heart disease as a result of chemoradiation treatment for lung cancer. Researchers also want to learn if the risk can be reduced by using a patient's individual risk profile to guide cancer treatment and help protect the heart.

Detailed Description

PRIMARY OBJECTIVE:

I.To longitudinally assess cardiac injury (serum biomarkers, and grade \>=2 cardiac events), and overall cardiac fitness (6-minute-walk test) in LA-NSCLC patients receiving chemoradiation.

OUTLINE:

Patients undergo single photon emission computed tomography (SPECT)/computed tomography (CT) with stress test and echocardiogram with strain before radiation therapy (RT), 6-8 weeks and 12 months after completion of RT. Patients also participate in 6 minute walk test (MWT) before RT, 2-3 and 6-7 weeks during RT, then 6-8 weeks, 4-6 months and 12 months after completion of RT. Patients undergo blood sample collection and complete questionnaires over 3-5 minutes before RT, 2-3, 4-5, 6-7 weeks after the initiation of RT, then at 3, 6, 12, and 24 months after completion of RT.

After completion of study treatment, patients are followed up annually for up to 10 years.

Study Timeline

• Study First Submitted: 2021-04-12
• Study Start: 2021-07-05
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-18
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-04
• Last Update Posted: 2025-09-05
• Primary Completion: 2026-02-23
• Study Completion: 2026-02-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Patient with histologic diagnosis of non-small cell lung cancer, small cell lung cancer, or limited stage - small cell lung cancer (L-SCLC)
2. The recommended treatment is thoracic radiation therapy combined with concurrent systemic therapy (chemotherapy and/or immunotherapy) with or without neoadjuvant and/or adjuvant systemic therapy (chemotherapy, immunotherapy, targeted therapy)
3. >/= 18 years of age
4. KPS >/= 70
5. Willing and able to sign informed consents
6. Willing to perform 6minute walking test
7. Willing to preform required cardiac biomarker test for primary end point assessment.

Exclusion criteria:

1. Unable or unwilling to give written informed consent
2. Previous history of RT to the thorax overlapping with the current treatment field.
3. Pregnant or breast-feeding
4. Renal failure necessitating dialysis
5. Unwilling to perform protocol tests
6. Contraindication for any protocol tests

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Increase in level of hs-TnT >= 5ng/L	up to 24 months	Baseline up to end or chemoradiation (CRT)
Incidence of grade >= 2 cardiovascular events	Within 12-month of completion of CRT]	Defined by Common Terminology Criteria for Adverse Events version 5.0.

Secondary Outcome Measures

Name	Time	Method
MD Anderson Symptom Inventory-Lung Cancer: Patient Report outcomes	Up to 24 months after CRT	Score Range 0-10 (0) No symptom and (10) worst symptoms
EuroQol 5 Dimension 5 Level: Patient reported outcomes	Up to 24 months after CRT	Score Range 0-100 (0) Worst health and (100) best health Level 1- No complaints Level 5- Worst
Overall survival	Up to 10 years
Overall cardiac fitness	Up to 24 months after CRT	Assessed using 6 minute walk test.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States