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

14 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

Is lung cancer surgery generally safe for humans?

Lung cancer surgery is considered a standard treatment, but it can have complications. Studies show that adverse events (unexpected problems) can happen after surgery, but efforts to improve surgical techniques and care quality have helped reduce these issues. ^{6 7 8 9 10}

How does standard-of-care surgery for lung cancer differ from other treatments?

Standard-of-care surgery for lung cancer typically involves a lobectomy with systematic nodal dissection, which is considered the gold standard for early-stage lung cancer. This approach is unique because it focuses on removing a lobe of the lung along with nearby lymph nodes to ensure thorough treatment, and it is often preferred due to its established effectiveness in early-stage cases. ^{11 12 13 14 15}

What is the purpose of this trial?

The SAVED LUNG study is a pilot Phase I trial evaluating safety and feasibility of observation versus standard-of-care surgery in operable Stage II-III (excluding N3) NSCLC patients (PD-L1 ≥50%) who achieve complete clinical response following neoadjuvant platinum-doublet chemotherapy and immunotherapy. Participants are randomized to observation or surgery after rigorous restaging, with primary endpoints focusing on safety and feasibility. Secondary objectives include rates of cross-over to surgery, event-free survival, and overall survival, while exploratory endpoints examine ctDNA clearance and its association with clinical response.

Research Team

Antoine Desilets, MD, MSc

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

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

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

Participants must have signed the written consent

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Immunotherapy Outcomes in Individuals With Non-Small Cell Lung Cancer and Poor Performance Status. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Survival Before and After Direct Surgical Quality Feedback in a Population-Based Lung Cancer Cohort. [2020]

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

Closing the gap: Contribution of surgical best practices to outcome differences between high- and low-volume centers for lung cancer resection. [2021]

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

The place of patient satisfaction in quality assessment of lung cancer thoracic surgery. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Patient reported outcome data as performance indicators in surgically treated lung cancer patients. [2020]

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

Standardized Postoperative Adverse Event Data Collection to Document, Inform, and Improve Patient Care. [2021]

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

Increased reporting but decreased mortality associated with adverse events in patients undergoing lung cancer surgery: Competing forces in an era of heightened focus on care quality? [2020]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Predictors of mortality after surgical management of lung cancer in the National Cancer Database. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluating the reliability and reproducibility of the Ottawa Thoracic Morbidity and Mortality classification system. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of Adverse Events and Length of Stay on Patient Experience After Lung Cancer Resection. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

[Standardization of lung cancer surgery]. [2011]

12. England pubmed.ncbi.nlm.nih.gov

Adjuvant therapy in non-small cell lung cancer: is targeted therapy joining the standard of care? [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Lung cancer staging and treatment in multidisciplinary trials: Cancer and Leukemia Group B cooperative group approach. Thoracic Surgeons of CALGB. [2019]

14. Switzerland pubmed.ncbi.nlm.nih.gov

[Modern Aspects of Lung Cancer Surgery]. [2019]

15. England pubmed.ncbi.nlm.nih.gov

Curable lung cancer. How to find it and treat it. [2016]