Maintenance Chemotherapy for Lung Cancer

Not currently recruiting at 342 trial locations

Overseen By Christopher A. Biggs

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NRG Oncology

Must be taking: Immunotherapy, Platinum-based chemotherapy

Must not be taking: Targeted therapy, Antiangiogenic therapy

Disqualifiers: Untreated brain metastases, Prior invasive malignancy, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding local consolidation therapy, such as focused radiation or surgery, to maintenance chemotherapy is more effective for treating stage IV non-small cell lung cancer than chemotherapy alone. Chemotherapy drugs like docetaxel (also known as Taxotere, Docefrez, Docivyx, DTX, or DXL) and pemetrexed aim to stop or slow cancer cell growth. This trial may suit those diagnosed with advanced non-small cell lung cancer, with limited metastases (cancer spread to three or fewer areas), and who have responded to initial treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important advancements in cancer care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments in this trial—docetaxel, erlotinib hydrochloride, gemcitabine, and pemetrexed disodium—are generally safe, though they can cause some side effects.

Studies have found that docetaxel effectively treats advanced non-small-cell lung cancer and is usually safe, though it can cause dehydration and low white blood cell counts. Erlotinib hydrochloride has improved survival and quality of life in lung cancer patients, but it may cause reactions when combined with other medications. Gemcitabine is well-tolerated and promising for lung cancer treatment, but like most chemotherapy drugs, it can have side effects. Lastly, pemetrexed disodium is considered safe for treating non-squamous lung cancer, provided patients have healthy kidney function.

These treatments have been studied in various settings, and while they offer potential benefits, awareness of possible side effects is important. Prospective trial participants should discuss these findings with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for lung cancer because they combine systemic maintenance chemotherapy with local consolidative therapy (LCT), which isn't common in standard care. Typically, treatments focus on systemic chemotherapy alone, but this trial explores using LCT, such as surgery or targeted radiation, alongside drugs like docetaxel, erlotinib, gemcitabine, and pemetrexed. This dual approach aims to attack cancer on multiple fronts, potentially improving outcomes by both reducing tumor size locally and preventing further spread. Additionally, incorporating pembrolizumab for non-squamous non-small cell lung cancer introduces an immunotherapy component, which is a novel addition to the treatment regimen. The combination of these therapies could lead to more effective control of the disease with potentially fewer side effects.

What evidence suggests that this trial's treatments could be effective for stage IV non-small cell lung cancer?

Research has shown that docetaxel, one of the treatments in this trial, effectively treats non-small cell lung cancer, helping patients live longer than with other treatments. Specifically, studies found that patients lived a median of 7.5 months with docetaxel, compared to 4.6 months with only supportive care. Erlotinib hydrochloride, another treatment option in this trial, not only extends patients' lives but also improves their quality of life. When used as ongoing treatment, it significantly prolongs the time patients live without the cancer worsening. Gemcitabine, also part of this trial, is a strong treatment for this type of lung cancer, as studies have shown it can slow the disease. Pemetrexed disodium, included for patients with non-squamous types of lung cancer in this trial, has shown promise by improving overall survival rates. These treatments, whether used alone or together in the various arms of this trial, show promise in effectively managing stage IV non-small cell lung cancer. ^{6 7 8 9 10}

Who Is on the Research Team?

Puneeth Iyengar

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5312469/

Docetaxel in the treatment of non-small cell lung carcinoma This study showed improved response and survival with the cisplatin plus docetaxel regimen as compared to the cisplatin plus vinorelbine arm (31.6% versus 24.5% ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7944306/

Docetaxel maintenance therapy versus best supportive care ... The present TFINE study assessed the efficacy and safety of docetaxel continuation maintenance (DCM) therapy after first-line treatment with different doses of ...

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)33289-2/fulltext

Efficacy of Docetaxel for Non-Small-Cell Lung Cancer as ... The overall response rate was 17.6%. The median progression-free survival was 68 days. The median survival time was 328 days.Grade3/4 toxicities were ...

4. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00480-7/fulltext

Efficacy and safety of second-line therapy of docetaxel plus ... Approximately 10% of patients treated with ICI plus platinum-based chemotherapy achieved progression-free survival (PFS) over 5 years; however, ...

5. cancernetwork.com cancernetwork.com/view/docetaxel-previously-treated-non-small-cell-lung-cancer

Docetaxel for Previously Treated Non-Small-Cell Lung ... Median survival was 7.5 months with docetaxel at 75 mg/m² (D75) vs 4.6 months for best supportive care (P = .010); and 1-year survival was 37% for D75 vs 11% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4773308/

Safety and efficacy of single‐agent docetaxel (Taxotere) ... Of 274 patients analyzed, one patient achieved a complete response and 42 partial responses; thus, the overall response rate was 15.7%. The OS rate at baseline ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4531008/

a meta-analysis of Phase III randomized controlled trials Docetaxel leads to a better result than vinca alkaloid in effectiveness and safety on patients with advanced non-small-cell lung cancer as first-line therapy.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03407300

A Safety and Efficacy Trial of Docetaxel With or Without ... This is a prospective, randomized, multicenter clinical study designed to evaluate its safety and efficacy by using Docetaxel with or without Traditional ...

9. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0331979

Assessing the real-world safety of docetaxel for non-small cell ... The results identified potential adverse reactions associated with docetaxel that were not included in the drug label, such as dehydration, leukopenia, acute ...

10. ascopubs.org ascopubs.org/doi/10.1200/JCO.2000.18.10.2095

Prospective Randomized Trial of Docetaxel Versus Best ... For patients with more advanced tumors, the hazards ratio for chemotherapy is 0.73, with a 10% absolute improvement in survival at 1 year over supportive care ...