Maintenance Chemotherapy for Lung Cancer

Recruiting at 332 trial locations

Overseen By Christopher A. Biggs

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: NRG Oncology

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Puneeth Iyengar

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for adults with stage IV non-small cell lung cancer who are in good general health and have responded to or have stable disease after initial therapy. They must be able to follow the study plan, use contraception if they can have children, and meet specific blood test and organ function criteria.

Inclusion Criteria

I am mentally and physically able to follow the study's requirements.

I agree to use birth control during and up to 6 months after the trial.

My kidney function is sufficient, with a creatinine clearance rate of at least 45 mL/min.

Treatment Details

Interventions

• Docetaxel (Anti-metabolites)
• Erlotinib Hydrochloride (Tyrosine Kinase Inhibitor)
• Gemcitabine (Anti-metabolites)
• Local Consolidation Therapy (Radiation)
• Pemetrexed Disodium (Anti-metabolites)

Trial Overview The trial is testing whether adding local consolidation therapy (like radiation) to maintenance chemotherapy improves outcomes for patients with advanced lung cancer. Chemotherapy drugs like docetaxel and pemetrexed disodium aim to stop tumor growth by killing or preventing the division of cancer cells.

Participant Groups

Group I: Arm 2 (LCT + systemic maintenance chemotherapy) Experimental Treatment 8 Interventions

Patients undergo local consolidative therapy (LCT) over 2-5 weeks, consisting of SBRT/hypofractionated radiation to the primary tumor and metastatic sites or surgery of metastatic sites. Hypofractionated radiation using IMRT or 3D-CRT can be given in place of SBRT. Within 2 weeks after completion of LCT (3 weeks if surgery occurred), patients receive chemotherapy as in Arm 1.

Group II: Arm 1 (systemic maintenance chemotherapy) Active Control 5 Interventions

Patients may receive docetaxel IV over 60 minutes on day 1, erlotinib hydrochloride by mouth daily, or gemcitabine IV over 30 minutes on days 1 and 8. Patients with non-squamous non-small cell lung cancer may receive pemetrexed disodium IV over 10 minutes on day 1 alone or in combination with pembrolizumab IV over 30 minutes. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Docetaxel is already approved in Canada, Japan for the following indications:

Approved in Canada as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Japan as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+