Chemotherapy for Non-Small Cell Lung Cancer

(LUNG-05 Trial)

Overseen By Ruihong Yin

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Antibiotics, Vaccines

Disqualifiers: Infection, HIV/AIDS, Lung disease, others

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

Compensation: Varies

Number of Visits: 7

Duration: Every 6-8 weeks through study completion, an average of 2 years

29 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the most effective chemotherapy treatment for individuals with advanced Non-Small Cell Lung Cancer (NSCLC) that has metastasized and who have previously tried at least one other treatment. Participants will receive one of several FDA-approved drugs, such as Docetaxel or Paclitaxel, in accordance with expert guidelines. This trial suits those with Stage IV NSCLC who have discontinued other treatments for at least two weeks and are prepared to try a new option. As an unphased trial, it offers patients the chance to explore new treatment options that could potentially enhance their quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have received any cancer treatment for at least 2 weeks before starting the trial.

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

Previous studies have shown that each chemotherapy in this trial has a specific safety profile. Docetaxel can cause side effects like dehydration and a decrease in white blood cells, with serious side effects reported in about 25.6% to 42.1% of patients. Gemcitabine is generally well tolerated, even at higher doses, though specific side effects can occur. Paclitaxel has proven effective and tolerable, but safety outcomes depend on the drug combination used. Pemetrexed is FDA-approved and commonly used for non-small cell lung cancer (NSCLC), with typical side effects related to blood. Lastly, vinorelbine is reported to be safe and well tolerated, with the main concern being a severe reduction in a type of white blood cell. Each drug has a unique safety profile, and these factors are important to consider when thinking about participating in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to pinpoint the most effective chemotherapy for treating non-small cell lung cancer (NSCLC) from a list of FDA-approved options. Unlike other treatments, this trial uses OncoChoiceTM, a novel approach that ranks drugs based on their activity levels — active, inactive, or moderately active. This method could streamline treatment decisions, potentially leading to more personalized and effective therapy plans for patients with NSCLC.

What evidence suggests that this trial's treatments could be effective for Non-Small Cell Lung Cancer?

Studies have shown that docetaxel can help people with non-small cell lung cancer (NSCLC) live longer and respond better to treatment. One study found that adding docetaxel to treatment improved survival chances compared to some other drug combinations. Research has shown that gemcitabine can extend survival times and is commonly used for advanced lung cancer. Paclitaxel, often used with other drugs, demonstrated good response rates and improved survival when combined with carboplatin. Pemetrexed is particularly effective for non-squamous NSCLC and works well in different treatment stages, including first-line, maintenance, and later treatments. Lastly, vinorelbine has increased survival times and is a good option for some NSCLC patients. Various studies have shown promise in managing NSCLC with each of these treatments. In this trial, the OncoChoiceTM results will rank the effectiveness of these pre-selected chemotherapies for NSCLC. ^{3 6 7 8 9}

Who Is on the Research Team?

Frank Weinberg, MD, PhD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for adults with advanced Stage IV non-small cell lung cancer who have already tried at least one systemic therapy. They must be in fairly good health, able to perform daily activities with minimal assistance (ECOG ≤2), and have proper organ function. Women must not be pregnant or breastfeeding, and all participants should understand the study requirements.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

My lung cancer is advanced (Stage IV) and confirmed by biopsy.

My organ functions are within the required range for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive OncoChoice-informed chemotherapy following NCCN guidelines for NSCLC FDA-approved drugs

Every 6-8 weeks through study completion, an average of 2 years

Regular visits every 6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Periodic visits

What Are the Treatments Tested in This Trial?

Interventions

• Docetaxel
• Gemcitabine
• Paclitaxel
• Pemetrexed
• Vinorelbine

Trial Overview The LUNG-05 study tests chemotherapy effectiveness for metastatic NSCLC patients using OncoChoice-informed chemo following NCCN guidelines. It's a single-arm pilot where drugs like Gemcitabine, Pemetrexed, Docetaxel are given based on FDA-approved dosages and schedules.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 5 Interventions

OncoChoiceTM results will provide ranking of drug effectiveness (e.g., active, inactive, moderately active drug) across a list of pre-selected chemotherapies (FDA-approved NSCLC treatments

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

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. sciencedirect.com sciencedirect.com/science/article/pii/S294982012400002X

Real-world survival of patients treated with taxane therapy ... For the 223 patients who received docetaxel–ramucirumab combination therapy, the median OS was 7.6 months (95% CI 6.6-8.9 months), and OS rates were 33% and 15% ...

3. oncotarget.com oncotarget.com/article/28444/text/

Value of chemotherapy post immunotherapy in stage IV ... Our study reported a 24% response rate to Docetaxel including stable disease and partial response and a median progression free survival (PFS) of 3 months.

4. lungcancerjournal.info lungcancerjournal.info/article/S0169-5002(24)00494-X/fulltext

Real-world comparative effectiveness of sotorasib versus ... First study comparing real-world effectiveness of sotorasib vs. docetaxel treatment. Median OS was longer with sotorasib vs. docetaxel (2L HR=0.62; 2L+HR=0.65).

5. ascopubs.org ascopubs.org/doi/10.1200/JCO-24-01544

Datopotamab Deruxtecan Versus Docetaxel for Previously ... Dato-DXd significantly improved PFS versus docetaxel in patients with advanced/metastatic NSCLC, driven by patients with nonsquamous histology.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12431403/

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

7. 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 ...

8. beyondspringpharma.com beyondspringpharma.com/beyondspring-presents-efficacy-safety-data-from-a-phase-2-study-of-pembrolizumab-plus-plinabulin-docetaxel-in-metastatic-nsclc-after-progressing-on-first-line-immune-checkpoint-inhibitors-at-2025/

BeyondSpring Presents Efficacy/Safety Data from a Phase ... 303 Study is an open-label, single-arm Phase 2 Study of Plinabulin plus docetaxel and pembrolizumab for previously treated patients with metastatic NSCLC.

9. 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.