Surgical Procedures for Early-Stage Lung Cancer

Not currently recruiting at 390 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alliance for Clinical Trials in Oncology

Disqualifiers: Prior malignancy, Chemotherapy, Radiation, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates different surgical options for treating early-stage lung cancer, specifically non-small cell lung cancer at stage IA. The goal is to determine if less invasive surgeries, such as wedge resection or segmentectomy (also known as anatomical segmental resection or sublobar resection), are as effective as the standard lobectomy, while potentially offering fewer side effects and quicker recovery. Suitable candidates for this trial include those with a small lung nodule (2 cm or less) that is likely cancerous and located in the outer third of the lung. Participants should not have had other recent cancers, except for certain types like non-melanoma skin cancer. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that both segmentectomy and wedge resection surgeries are generally safe for treating early-stage lung cancer. Segmentectomy may lead to more complications than wedge resection, but it often helps patients live longer. While recovery might be more challenging, the long-term benefits can be greater.

Wedge resection is a safe and effective choice for some patients, typically resulting in a shorter hospital stay. However, the chances of extended survival are not as high as with lobectomy or segmentectomy.

Overall, these surgeries are well-tolerated, each with its own advantages and disadvantages. Discussing options with a doctor is crucial to determine the best choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these surgical techniques for early-stage lung cancer because they offer potentially less invasive options compared to the standard lobectomy. While lobectomy involves removing an entire lobe of the lung, segmentectomy and wedge resection remove smaller portions, which may preserve more lung function and promote faster recovery. These techniques could be game-changers for patients who are unable to undergo more extensive surgeries due to health constraints. By exploring these less extensive resections, doctors hope to maintain similar cancer control while improving quality of life.

What evidence suggests that this trial's surgical procedures could be effective for early-stage lung cancer?

This trial will compare different surgical procedures for early-stage lung cancer. Studies have shown that a lobectomy, which participants in Arm A of this trial will undergo, generally offers the best survival rates for early-stage non-small cell lung cancer, with a 5-year survival rate of about 71.9%. Participants in Arm B will undergo a limited resection, either a segmentectomy or wedge resection. Research has found that a segmentectomy, which removes a smaller part of the lung, offers similar survival rates to lobectomy, with a 5-year survival rate of 69.6%. This makes it a good option for patients who may not handle more extensive surgery well. In contrast, a wedge resection, which removes the least amount of lung tissue, tends to have poorer outcomes, with survival rates below 45% in some studies. This suggests that while less invasive surgeries might be easier to recover from, they might not be as effective in the long run. ^{2 3 5 6 7}

Who Is on the Research Team?

Nasser Altorki, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with early-stage IA non-small cell lung cancer. Candidates should have a small lung nodule presumed to be cancer, located in the outer part of the lung, and no advanced or metastatic disease. They must not have had other cancers (except certain skin, bladder, or cervical cancers) in the past 3 years and no prior treatments for this cancer.

Inclusion Criteria

I haven't had chemotherapy or radiation for my cancer.

I can take care of myself and am up and about more than half of the day.

I haven't had cancer, except for certain skin, bladder, or cervical cancers, in the last 3 years.

Exclusion Criteria

My lung scans show ground glass opacities or I have N1 or N2 lung cancer.

Your doctor hasn't confirmed that there is no cancer spread using a quick frozen tissue test.

My right-sided tumor's nodes 4, 7, and 10 were not confirmed negative.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either a lobectomy or a sublobar resection (segmentectomy or wedge resection) to treat stage IA non-small cell lung cancer

Surgical procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up every 6 months for 2 years and then annually for 5 years

7 years

What Are the Treatments Tested in This Trial?

Interventions

• Lobectomy
• Segmentectomy
• Wedge Resection

Trial Overview

The study is comparing two less invasive surgical methods—segmentectomy or wedge resection—with lobectomy to see which one works better for stage IA non-small cell lung cancer. Patients will be randomly assigned to undergo one of these surgeries.

How Is the Trial Designed?

Group I: Arm B Experimental Treatment 1 Intervention

Patents undergo a limited resection (segentectomy or wedge resection), which a smaller portion of the lung is removed.

Group II: Arm A Experimental Treatment 1 Intervention

Patients undergo a standard operation for lung cancer called a lobectomy.

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study analyzing data from the Surveillance, Epidemiology, and End Results database involving patients with early non-small cell lung cancer (NSCLC), segmentectomy showed similar overall survival (OS) and lung cancer-specific survival (LCSS) rates compared to lobectomy after adjusting for biases through propensity score matching.

Before matching, lobectomy was associated with better survival outcomes, but after matching, the differences in survival rates between segmentectomy and lobectomy were not statistically significant, suggesting that segmentectomy can be a viable surgical option for patients with early-stage NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lobectomy versus segmentectomy in patients with stage T (> 2 cm and ≤ 3 cm) N0M0 non-small cell lung cancer: a propensity score matching study. Wang, L., Ge, L., You, S., et al.[2022]

Anatomical segmentectomy, compared to lobectomy, significantly reduces postoperative complications such as atelectasis, pneumonia, and prolonged air leaks, indicating it may be a safer surgical option for early-stage lung cancer.

Despite the reduced morbidity associated with segmentectomy, there was no significant difference in postoperative mortality rates at 30, 60, or 90 days, suggesting that while segmentectomy may lead to fewer complications, it does not impact overall survival in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interest of anatomical segmentectomy over lobectomy for lung cancer: a nationwide study. Berg, E., Madelaine, L., Baste, JM., et al.[2022]

Lobectomy is associated with better 5-year survival rates (57.5%) compared to sublobar resection (36%) in patients with second primary lung cancer, suggesting it should be the preferred treatment option.

Sublobar resection remains a valid alternative for high-risk patients with limited lung function, while completion pneumonectomy is linked to significantly poorer long-term survival (20%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is lobectomy really more effective than sublobar resection in the surgical treatment of second primary lung cancer? Zuin, A., Andriolo, LG., Marulli, G., et al.[2022]

Sublobar resection, including both non-anatomic wedge resection and anatomic segmentectomy, is a promising alternative to lobectomy for selected lung cancer patients, potentially causing less pulmonary compromise.

Current evidence suggests that sublobar resection may achieve survival outcomes similar to lobectomy for patients with stage IA lung cancer, tumors up to 2-3 cm, peripheral location, and predominantly ground-glass appearance on CT, but more research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-small cell lung cancer: when to offer sublobar resection. Sihoe, AD., Van Schil, P.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11396031/

The Role of Sublobar Resection in Early-Stage Non-Small- ...

On the basis of their results, the authors concluded that standard lobectomy was shown to confer a significant survival benefit when compared ...

2.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2212083

Lobar or Sublobar Resection for Peripheral Stage IA Non– ...

Here, we report the results of a randomized international trial comparing sublobar resection (wedge resection or segmentectomy) with lobectomy ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0169500224005245

Segmentectomy vs. Lobectomy in stage IA non-small cell ...

Segmentectomy shows comparable overall survival to lobectomy in early-stage NSCLC. Findings support tailored surgical approaches based on patient-specific ...

4.

spandidos-publications.com

spandidos-publications.com/10.3892/ol.2024.14469

Effectiveness and safety of segmentectomy vs. wedge ...

Based on current evidence, patients with NSCLC treated with ST surgery have better postoperative survival but more complications than those patients treated ...

5.

sts.org

sts.org/press-releases/anatomic-lung-resection-linked-improved-survival-early-stage-lung-cancer

Anatomic Lung Resection Linked to Improved Survival for ...

Segmentectomy, which resulted in a 5-year OS of 69.6% and 10-year OS of 44.2% proved to be a viable alternative. Both lobectomy and ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11193294/

Survival outcomes of segmentectomy and lobectomy for ...

The question of whether segmentectomy and lobectomy have similar survival outcomes for patients with early-stage non-small cell lung cancer ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0002961024006214

Sublobar or lobar resection in early-stage peripheral non- ...

Sublobar resection was found to be non-inferior to lobar resection concerning the 5-year survival rate, 5-year disease-free survival rate and cancer-related ...