Non-Small Cell Lung CancerPhase 1SAVED LUNGNCT06743555
Surgery After Verifying Existing Disease in Locally Advanced Operable Lung Cancer: A Pilot Study
A Phase 1 study testing Observation without surgery and Standard-of-care surgery in people with Non-Small Cell Lung Cancer and Immunotherapy, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer, Immunotherapy, Neoadjuvant Therapy
- What is being tested?
- Observation without surgery and Standard-of-care surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2026to Feb 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years of age
- The participant has provided documented informed consent for the trial.
- Histologically confirmed (by core biopsy) NSCLC and confirmed clinical stages II-III (excluding N2) NSCLC (AJCC 8th edition) amenable to receive neoadjuvant chemo-immunotherapy defined by: nivolumab 3mg/kg Q3W in combination with platinum doublet chemotherapy (cisplatin or carboplatin with paclitaxel or pemetrexed Q3W) for 3 cycles.
- PD-L1 tumor proportion score >50%
- Has no history of immunodeficiency, HBV, HCV, HIV.
- For female participants:
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- Has no active pregnancy (Refer to "Female participants").
- For a woman of child-bearing potential (WOCBP), use of a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least 180 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period.
- A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within either 24 hours (urine) or 72 hours (serum) before the first dose of study intervention.
- If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Has adequate hematological, renal and hepatic function per Investigator discretion required for platinum-doublet chemotherapy plus immunotherapy.
- Has signed the written consent.
Who cannot join
- Has one of the following tumor locations/types:
- NSCLC involving the superior sulcus
- Large cell neuro-endocrine cancer (LCNEC)
- Sarcomatoid tumor
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
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- Has had an allogenic tissue/solid organ transplant.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.
- Has a known additional malignancy that is progressing or requires active treatment within the past (5 years). Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, bladder carcinoma, or carcinoma in situ (eg, in situ cervical cancer or breast carcinoma) that have undergone potentially curative therapy are not excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
Antoine Desilets, MD, MSc, 514-890-8444, antoine.desilets.med@ssss.gouv.qc.ca
Wiam Belkaid, PhD, 514-836-3273 ext. 23242, wiam.belkaid.chum@ssss.gouv.qc.ca
About this study
Official title: Surgery After Verifying Existing Disease in Locally Advanced Operable Lung Cancer (SAVED LUNG Study): A Pilot Study
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.
Read the detailed description
After neoadjuvant therapy, all participants undergo intensified re-staging invasive and non-invasive modalities to assess for complete clinical response:
- Chest CT;
- PET/CT scan;
- Bronchoscopy;
- EBUS;
- EUS;
- Re-biopsy of lesions that were deemed to be positive for cancer; this includes re-biopsies of all positive lymph nodes and transthoracic needle aspiration of tumors.
Participants with complete clinical response defined by absence of disease as measured by all the above modalities will be randomized 1:1 to either observation or surgery.
Only patients with complete clinical response will proceed to the randomization stage of the trial. Block randomization will occur 1:1 with two participants per block. All other patients will remain on study and undergo therapy as per standard-of-care and will have follow-up on study. Both groups will have blood collected for ctDNA at this stage. For participants in the surgery arm, the blood sample will be 3 weeks after surgery, while participants in surveillance only arm will have the blood sample 3 weeks after randomization.
- Conditions
- Non-Small Cell Lung Cancer, Immunotherapy, Neoadjuvant Therapy, Thoracic Surgery, Complete Response
- Being tested
- Observation without surgery, Standard-of-care surgery
- Keywords
- NSCLC, Neoadjuvant immunotherapy, Complete response, Surveillance, PD-L1
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation without surgeryOther
Patients randomized to this arm will forego standard-of-care thoracic surgery and will undergo strict surveillance based on serial radiological follow-up and ctDNA monitoring
Standard-of-care surgeryProcedure or surgery
Patients randomized to this arm will undergo standard-of-care thoracic surgery and undergo post-operative surveillance with serial radiological follow-up and ctDNA monitoring
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care surgery | Active comparator | 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. Receives: Procedure: Standard-of-care surgery |
| Observation without surgery | Experimental | 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. Receives: Other: Observation without surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Adverse events will be determined as type and grade using the CTCAE v5.0.
Measured: From randomization through 5 years of follow-up
Feasibility
Recruitment rate will be defined as the total number of patients recruited (consented) out of the total number of patients approached.
Measured: First two years of the study
Secondary outcomes (5)
Complete clinical response
Defined by absence of cancer in all of the following evaluations:
- Chest CT;
- PET/CT scan;
- Bronchoscopy;
- EBUS;
- EUS;
- Re-biopsy of lesions that were deemed to be positive for cancer; this includes re-biopsies of all positive lymph nodes and transthoracic needle aspiration of tumors.
Measured: Restaging 3 weeks after completion of neoadjuvant therapy (3 cycles of nivolumab and platinum-doublet chemotherapy)
Cross-over to surgery
Defined as occurrence of surgery for lung cancer in the observation arm
Measured: From randomization through 5 years of follow-up
Event-free survival (EFS) at 12 months
Defined as the proportion of patients remaining event-free at 12 months, from the time of randomization. Patients who are alive without a documented progression will be censored at the time of their last disease evaluation.
Measured: 12 months following randomization
Overall survival (OS) at 12 months
Defined as the proportion of patients alive at 12 months, from the time of randomization.
Measured: 12 months following randomization
Circulation tumor DNA (ctDNA) clearance
Defined as presurgery change from detectable levels of ctDNA before cycle 1 to undetectable ctDNA before surgery.
Measured: 3 weeks post-randomization (surveillance arm) or 3 weeks post-surgery (standard-of-care surgery arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Oct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Desilets, MD, MSc, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743555
- Sponsor's protocol ID
- 2025-12255
- Other IDs
- 2025
- Acronym
- SAVED LUNG
- Status last verified
- Aug 2026
- First submitted
- 17 Dec 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16.
PubMed 29658848
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery After Verifying Existing Disease in Locally Advanced Operable Lung Cancer (SAVED LUNG Study): A Pilot Study
- ClinicalTrials.gov ID
- NCT06743555
- Acronym / sponsor ID
- SAVED LUNG / 2025-12255
- Conditions
- Non-Small Cell Lung Cancer, Immunotherapy, Neoadjuvant Therapy, Thoracic Surgery, Complete Response
- Keywords
- NSCLC, Neoadjuvant immunotherapy, Complete response, Surveillance, PD-L1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2032 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After neoadjuvant therapy, all participants undergo intensified re-staging invasive and non-invasive modalities to assess for complete clinical response:
- Chest CT;
- PET/CT scan;
- Bronchoscopy;
- EBUS;
- EUS;
- Re-biopsy of lesions that were deemed to be positive for cancer; this includes re-biopsies of all positive lymph nodes and transthoracic needle aspiration of tumors.
Participants with complete clinical response defined by absence of disease as measured by all the above modalities will be randomized 1:1 to either observation or surgery.
Only patients with complete clinical response will proceed to the randomization stage of the trial. Block randomization will occur 1:1 with two participants per block. All other patients will remain on study and undergo therapy as per standard-of-care and will have follow-up on study. Both groups will have blood collected for ctDNA at this stage. For participants in the surgery arm, the blood sample will be 3 weeks after surgery, while participants in surveillance only arm will have the blood sample 3 weeks after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care surgery | Active comparator | Procedure: Standard-of-care surgeryParticipants 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. |
| Observation without surgery | Experimental | Other: Observation without surgeryParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- > 18 years of age
- The participant has provided documented informed consent for the trial.
- Histologically confirmed (by core biopsy) NSCLC and confirmed clinical stages II-III (excluding N2) NSCLC (AJCC 8th edition) amenable to receive neoadjuvant chemo-immunotherapy defined by: nivolumab 3mg/kg Q3W in combination with platinum doublet chemotherapy (cisplatin or carboplatin with paclitaxel or pemetrexed Q3W) for 3 cycles.
- PD-L1 tumor proportion score >50%
- Has no history of immunodeficiency, HBV, HCV, HIV.
Key exclusion criteria (10 listed)
- Has one of the following tumor locations/types:
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has had an allogenic tissue/solid organ transplant.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation without surgeryPatients randomized to this arm will forego standard-of-care thoracic surgery and will undergo strict surveillance based on serial radiological follow-up and ctDNA monitoring | Other | Observation without surgery |
| Standard-of-care surgeryPatients randomized to this arm will undergo standard-of-care thoracic surgery and undergo post-operative surveillance with serial radiological follow-up and ctDNA monitoring | Procedure or surgery | Standard-of-care surgery |
Primary outcome
Safety
Time frame: From randomization through 5 years of follow-up
Adverse events will be determined as type and grade using the CTCAE v5.0.
Feasibility
Time frame: First two years of the study
Recruitment rate will be defined as the total number of patients recruited (consented) out of the total number of patients approached.
5 secondary outcomes
Complete clinical response
Time frame: Restaging 3 weeks after completion of neoadjuvant therapy (3 cycles of nivolumab and platinum-doublet chemotherapy)
Cross-over to surgery
Time frame: From randomization through 5 years of follow-up
Event-free survival (EFS) at 12 months
Time frame: 12 months following randomization
Overall survival (OS) at 12 months
Time frame: 12 months following randomization
Circulation tumor DNA (ctDNA) clearance
Time frame: 3 weeks post-randomization (surveillance arm) or 3 weeks post-surgery (standard-of-care surgery arm)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Results publication: PubMed 29658848Forde PM, Chaft JE, Smith KN, Anagnostou V, Cottrell TR, Hellmann MD, Zahurak M, Yang SC, Jones DR, Broderick S, Battafarano RJ, Velez MJ, Rekhtman N, Olah Z, Naidoo J, Marrone KA, Verde F, Guo H, Zhang J, Caushi JX, Chan HY, Sidhom JW, Scharpf RB, White J, Gabrielson E, Wang H, Rosner GL, Rusch V, Wolchok JD, Merghoub T, Taube JM, Velculescu VE, Topalian SL, Brahmer JR, Pardoll DM. Neoadjuvant PD-1 Blockade in Resectable Lung Cancer. N Engl J Med. 2018 May 24;378(21):1976-1986. doi: 10.1056/NEJMoa1716078. Epub 2018 Apr 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Antoine Desilets, MD, MSc principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Observation without surgery and Standard-of-care surgery in people with Non-Small Cell Lung Cancer and Immunotherapy, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine Desilets, MD, MSc (514-890-8444, antoine.desilets.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: From randomization through 5 years of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06743555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.