NCT03137771

Maintenance Chemotherapy With or Without Local Consolidative Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

Maintenance Systemic Therapy Versus Local Consolidative Therapy (LCT) Plus Maintenance Systemic Therapy for Limited Metastatic Non-Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: NRG Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without local consolidation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, erlotinib hydrochloride, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Local consolidation therapy such as radiation/stereotactic body radiation or surgery may kill cancer cells left after initial treatment. Giving maintenance chemotherapy and local consolidation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.

Detailed description

PRIMARY OBJECTIVES: Phase II To evaluate the impact of adding local consolidative therapy (LCT) to maintenance systemic therapy versus maintenance systemic therapy alone on progression-free survival for patients with metastatic non-small cell lung cancer (NSCLC) with no evidence of progression and limited metastatic sites after first-line systemic therapy. Phase III To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on overall survival for patients with metastatic NSCLC with no evidence of progression and limited metastatic sites after first-line systemic therapy. SECONDARY OBJECTIVES: I. To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on in-field local failure. II. To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on the time to development of new lesions. III. To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on toxicity. IV. To evaluate the impact of adding LCT to maintenance systemic therapy versus maintenance systemic therapy alone on duration of maintenance systemic therapy usage. V. To evaluate the effect of adding LCT to systemic therapy in limited stage IV NSCLC on Quality of Life (QOL). VI. To collect biospecimens and evaluate the correlation between clinical outcomes and circulating tumor DNA (ctDNA). Patients are randomized 2:1 between the SBRT and chemotherapy vs. chemotherapy alone arms. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, then annually thereafter.

Conditions

• Recurrent Non-Small Cell Lung Carcinoma
• Stage IV Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	3-Dimensional Conformal Radiation Therapy (3D-CRT)	Undergo 3DCRT
DRUG	Docetaxel	Given IV
DRUG	Gemcitabine	Given IV
RADIATION	Intensity-Modulated Radiation Therapy (IMRT)	Undergo IMRT
DRUG	Pemetrexed Disodium	Given IV
RADIATION	Stereotactic Body Radiation Therapy (SBRT)	Undergo SBRT
DRUG	Erlotinib Hydrochloride	Given PO
DRUG	Pembrolizumab	Given IV

Timeline

• Start date: 2017-04-07
• Primary completion: 2023-12-20
• Completion: 2028-12-01
• First posted: 2017-05-03
• Last updated: 2025-11-25
• Results posted: 2025-03-11

Locations

301 sites across 4 countries: United States, Canada, Israel, Saudi Arabia

Regulatory

• FDA-regulated drug study