Surgery for Lung Cancer

(SAVED LUNG Trial)

Overseen By Wiam Belkaid, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must be taking: Platinum chemotherapy, Immunotherapy

Disqualifiers: Pneumonitis, Active infection, Transplant, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether individuals with certain types of lung cancer can safely skip surgery after responding well to initial treatments like chemotherapy and immunotherapy. Researchers aim to determine if simply observing patients is as effective as standard-of-care surgery, with a focus on safety and future health outcomes. Those with Stage II-III non-small cell lung cancer with specific characteristics and no recent serious infections might find this trial suitable. Participants will either undergo surgery with regular follow-ups or receive regular follow-ups without surgery to compare results. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative approach.

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 team or your doctor.

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

Research has shown that lung surgery can yield varying results. Studies indicate that complications occur in 25% to 40% of cases, meaning about one in four to two in five patients might experience issues post-surgery. However, patients tend to recover better and face fewer problems with a more experienced surgeon.

This trial is in its early stages, focusing primarily on safety. The treatment is still under testing, and researchers will closely monitor for any side effects or complications.

Prospective participants should discuss joining this trial with their healthcare provider. Providers can offer more information and help assess the benefits and risks based on individual health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of managing lung cancer with observation instead of immediate surgery. The unique approach involves close surveillance using regular low-dose CT scans and ctDNA testing to monitor the cancer's status without surgical intervention. This method could lead to less invasive management for patients, reducing the risks and recovery time associated with surgery. By comparing this observational protocol to standard surgical treatment, researchers aim to determine if some patients can safely avoid surgery, potentially transforming how lung cancer is managed in the future.

What data supports the effectiveness of the treatment Observation without surgery, Standard-of-care surgery for lung cancer?

Research shows that surgical resection (removal of cancerous tissue) is the main way to cure non-small cell lung cancer (NSCLC), and improving the quality of surgery can lead to better survival rates. High-volume centers, which perform more surgeries, tend to have better outcomes, suggesting that following best surgical practices can improve results.

Who Is on the Research Team?

Antoine Desilets, MD, MSc

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for people with Stage II-III non-small cell lung cancer (NSCLC) who have a high PD-L1 level (≥50%) and show no signs of cancer after chemotherapy and immunotherapy. They must be able to undergo surgery if needed, but can't join if they have the most advanced lymph node involvement (N3).

Inclusion Criteria

Participants must have provided documented informed consent for the trial

Participants must have signed the written consent

My blood, kidney, and liver functions are good enough for specific cancer treatment.

Exclusion Criteria

Participants with known psychiatric or substance abuse disorders that would interfere with trial requirements

I am currently being treated for an infection.

I have received an organ or tissue transplant from another person.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Therapy

Participants receive neoadjuvant platinum-doublet chemotherapy and immunotherapy

9 weeks

Restaging

Intensified re-staging using invasive and non-invasive modalities to assess for complete clinical response

3 weeks

Randomization and Treatment

Participants with complete clinical response are randomized to observation or surgery

12 months

Every 3 months

Follow-up

Long-term follow-up with assessments every 6-12 months up to 5 years

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Observation without surgery
• Standard-of-care surgery

Trial Overview The SAVED LUNG study tests whether patients with NSCLC who respond well to initial treatments need standard surgery or can just be observed without immediate surgery. It's a Phase I trial where participants are randomly chosen for either continued observation or surgery.

How Is the Trial Designed?

Group I: Observation without surgery Experimental Treatment 1 Intervention

Participants undergo surveillance without surgery, including a low-dose CT scan of the thorax and upper abdomen, ECOG assessment, and physical examination every 3 months for the first 12 months. Additional ctDNA testing is performed 3 weeks post-randomization and at 6 months. Long-term follow-up includes similar assessments every 6-12 months up to 5 years.

Group II: Standard-of-care surgery Active Control 1 Intervention

Participants undergo surgery followed by the same surveillance schedule as Arm A. ctDNA testing is conducted 3 weeks post-surgery and again at 6 months. Surveillance includes low-dose CT scans, physical examinations, and ECOG assessments every 3 months for 12 months, with long-term monitoring at regular intervals up to 5 years.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

In a study of 119,146 patients with non-small cell lung cancer (NSCLC) who underwent surgical resection, the overall 30-day mortality rate was found to be 3.4%, with higher rates associated with more complex procedures like pneumonectomy (8.5%).

Factors such as increasing age, male sex, higher comorbidities, and lower facility volume were linked to increased 30-day mortality and longer hospital stays, indicating that these variables can help predict surgical outcomes in NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of mortality after surgical management of lung cancer in the National Cancer Database. Rosen, JE., Hancock, JG., Kim, AW., et al.[2022]

A study of 2,206 patients with non-small cell lung cancer showed that providing performance feedback to surgical teams significantly improved 5-year survival rates from 47% before the intervention to 53% after, indicating enhanced surgical outcomes.

The use of preoperative imaging techniques, such as PET/CT scans and bronchoscopy, increased significantly after the feedback campaign, which likely contributed to better patient selection and staging, particularly benefiting those undergoing pneumonectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival Before and After Direct Surgical Quality Feedback in a Population-Based Lung Cancer Cohort. Smeltzer, MP., Faris, NR., Ray, MA., et al.[2020]

Standardized data collection of postoperative adverse events in thoracic surgery can significantly enhance patient care by documenting and informing practices to reduce complications.

Engaging surgeons in audit and feedback based on this data can lead to consensus recommendations that improve patient outcomes following high-risk surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized Postoperative Adverse Event Data Collection to Document, Inform, and Improve Patient Care. Shamji, FM., Gingrich, M., Anstee, C., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12427398/

Failure to Rescue and Lung Resections for Lung Cancer - PMC Recent literature indicates that overall complication rates following lung resection vary between 25% and 40%, with major complications observed ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.00745

Quality Surgical Care and Outcomes for Patients With Non ... Lung cancer resections by more specialized surgeons have been associated with better outcomes. Specialization is also associated with improved ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022522322010261

Lung Cancer Clinical and financial outcomes of pulmonary ... Hospital safety-net status is associated with greater rates of complications and costs after lobectomy for lung cancer.

4. massgeneral.org massgeneral.org/surgery/thoracic-surgery/treatments-and-services/lung-cancer-patient-outcomes

Patient Outcomes for Lung Cancer Our rate of mortality (death) from lobectomy for lung cancer is lower than the STS and NIS databases. We also performed 77% of our Stage 1 cancer operations.

5. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2025/ten-year-clinical-trial-report-finds-radiation-comparable-to-surgery-for-early-stage-nsclc

Ten-year clinical trial report finds radiation comparable to ... Dr. Chang and his colleagues previously reported three- and five-year overall survival rates of 91% and 87% following SABR. They also reported ...