Maintenance Chemotherapy for Lung Cancer

Recruiting at 332 trial locations

Overseen By Christopher A. Biggs

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NRG Oncology

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 21

Duration: 21 days per cycle, repeated until disease progression or unacceptable toxicity

218 Participants Needed

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on targeted therapy for NSCLC or certain other treatments, you may not be eligible to participate.

What data supports the effectiveness of the drug combination used in the Maintenance Chemotherapy for Lung Cancer trial?

Research shows that the combination of gemcitabine and docetaxel is effective in treating advanced non-small cell lung cancer (NSCLC), with studies indicating it can improve survival and has higher activity compared to using each drug alone. ^{1 2 3 4 5}

Is maintenance chemotherapy for lung cancer safe?

Research shows that treatments involving docetaxel, gemcitabine, and pemetrexed have been studied for lung cancer and are generally considered to have acceptable safety levels, though they can cause some side effects. These studies indicate that while the treatments are active against lung cancer, they do come with some toxicity, which is a common concern with chemotherapy. ^{1 2 6 7 8}

What makes the maintenance chemotherapy treatment for lung cancer unique?

This maintenance chemotherapy for lung cancer is unique because it combines multiple drugs like Docetaxel, Erlotinib, Gemcitabine, and Pemetrexed, which are used in different strategies such as continuation and switch maintenance, potentially offering a more tailored approach based on the patient's response to initial treatment. ^{9 10 11 12 13}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive maintenance chemotherapy with or without local consolidative therapy

21 days per cycle, repeated until disease progression or unacceptable toxicity

Every 21 days

Local Consolidative Therapy (LCT)

Participants undergo local consolidative therapy consisting of SBRT/hypofractionated radiation or surgery

2-5 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3 months for 2 years, every 6 months for 3 years, then annually

Treatment Details

Interventions

• Docetaxel
• Erlotinib Hydrochloride
• Gemcitabine
• Local Consolidation Therapy
• Pemetrexed Disodium

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 United States, European Union, Canada, Japan for the following indications:

Approved in United States as Taxotere for:

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

Approved in European Union as Taxotere for:

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

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+

Findings from Research

In a study of 170 patients with advanced non-small cell lung cancer, those treated with EGFR-TKIs as second-line therapy showed the highest response rate (36.1%) and the longest progression-free survival (PFS) of 9.31 months, compared to 15.0% response rate and 5.49 months PFS for docetaxel and 24.5% response rate and 5.42 months PFS for pemetrexed.

All three treatments (docetaxel, pemetrexed, and EGFR-TKIs) had comparable safety profiles, but there was no significant difference in median survival time (MST) among the groups, indicating that while EGFR-TKIs may offer better short-term benefits, long-term survival outcomes were similar across treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of docetaxol, pemetrexed and EGFR-TKIs as second-line treatment for patients with advanced non-small-cell lung cancer]. Zhang, RX., Cai, DY., Wu, XH., et al.[2018]

In a phase II study involving 40 patients with non-small-cell lung cancer (NSCLC) who had previously failed chemotherapy, the combination of monthly docetaxel and weekly gemcitabine showed a response rate of 32.5%, indicating its efficacy as a second-line treatment.

The treatment was generally safe, with severe non-hematologic toxicities being infrequent, although significant hematologic toxicities like grade 4 neutropenia were observed in 23 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-line chemotherapy for non-small-cell lung cancer with monthly docetaxel and weekly gemcitabine: a phase II trial. Spiridonidis, CH., Laufman, LR., Carman, L., et al.[2022]

Maintenance therapy for advanced nonsmall cell lung cancer can improve progression-free survival, with switch maintenance using pemetrexed or erlotinib showing the most clear clinical benefits.

Continuation maintenance with bevacizumab also improves progression-free survival, but the role of cetuximab remains unclear, highlighting the need to consider toxicity, quality of life, and cost in treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of maintenance treatments for nonsmall cell lung cancer. Eadens, MJ., Robinson, SI., Price, KA.[2020]

References

1. China pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of docetaxol, pemetrexed and EGFR-TKIs as second-line treatment for patients with advanced non-small-cell lung cancer]. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Gemcitabine-docetaxel versus cisplatin-vinorelbine in advanced or metastatic non-small-cell lung cancer: a phase III study addressing the case for cisplatin. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Gemcitabine plus docetaxel as first-line chemotherapy in patients with advanced non-small cell lung cancer: a lung cancer Galician group phase II study. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Erlotinib, docetaxel, and gefitinib in sequential cohorts with relapsed non-small cell lung cancer. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Non-platinum regimens of gemcitabine plus docetaxel versus platinum-based regimens in first-line treatment of advanced non-small cell lung cancer: a meta-analysis on 9 randomized controlled trials. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Second-line chemotherapy for non-small-cell lung cancer with monthly docetaxel and weekly gemcitabine: a phase II trial. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

Docetaxel in combination with gemcitabine plus rhG-CSF support as second-line treatment in non-small cell lung cancer. A multicenter phase II study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Phase I/II trial of gemcitabine plus docetaxel in advanced non small cell lung cancer (NSCLC). [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Role of Gemcitabine and Pemetrexed as Maintenance Therapy in Advanced NSCLC: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

Tailoring maintenance chemotherapy upon response to induction chemotherapy as compared with pemetrexed continuation maintenance in advanced non-squamous NSCLC patients: Results of the IFCT-GFPC-1101 multicenter randomized phase III trial. [2022]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Effectiveness of maintenance treatments for nonsmall cell lung cancer. [2020]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Pemetrexed in maintenance treatment of advanced non-squamous non-small-cell lung cancer. [2020]

13. Germany pubmed.ncbi.nlm.nih.gov

Maintenance therapy with pemetrexed versus docetaxel after induction therapy with carboplatin and pemetrexed in chemotherapy-naïve patients with advanced non-squamous non-small-cell lung cancer: a randomized, phase II study. [2018]