Lung Cancer, Nonsmall CellPhase 2NCT04638582
Pembrolizumab as Neoadjuvant Therapy for Resectable Stage IA3 to IIA Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Lung Cancer, Nonsmall Cell, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
This is a prospective, randomized, single-site, open-label Phase II trial of neoadjuvant pembrolizumab (3 cycles) followed by surgery, versus concomitant neoadjuvant pembrolizumab with platinum doublet chemotherapy (3 cycles) followed by surgery for participants with Stage IA3, IB and IIA non-small-cell lung cancer… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Nonsmall Cell
- What is being tested?
- Pembrolizumab, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 28 Aug 2022to 14 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Previously untreated, histologically confirmed (by core biopsy) NSCLC and histologically confirmed stages IA3, IB and IIA NSCLC (AJCC 8th edition).
- Able to undergo protocol therapy, including necessary surgery.
- If female: may participate if no active pregnancy, not breastfeeding, and at least one of the following: is not a woman of childbearing potential (WOCBP), or is a WOCBP using contraceptive methods.
- If male: must agree to refrain from donating sperm, and must either be abstinent or agree to use contraception.
- ECOG 0-1
- Available formalin-fixed paraffin embedded (FFPE) tumor tissue samples
Who cannot join
- Has one of the following tumor locations/types: NSCLC involving the superior sulcus, large cell neuroendocrine cancer (LCNEC) or sarcomatoid tumor.
- History of immunodeficiency, HBV, HCV, HIV. No HBV, HCV or HIV testing is required unless mandated by local health authority.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has had an allogenic tissue/solid organ transplant.
- Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients. (Refer to the respective Investigator's Brochure for a list of excipients.)
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- Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents and/or to any of their excipients.
- Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- 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 received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant erythropoietin) within 2 weeks before randomization
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (eg, CTLA-4, OX-40, CD137).
- Has received prior systemic anticancer therapy including investigational agents for the current malignancy prior to randomization/allocation.
- Has received prior radiotherapy within 2 weeks of start of trial treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- Has received a live or live attenuated vaccine within 30 days prior to the first dose of trial drug. Note: killed vaccines are allowed.
- Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (dose exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug.
- Has a known additional malignancy that is progressing or requires active treatment within the past (5 years).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab or Pembrolizumab With Histology-Specific Chemotherapy for Operable Stage IA3 to IIA Non-Small Cell Lung Cancer (NSCLC)
This is a prospective, randomized, single-site, open-label Phase II trial of neoadjuvant pembrolizumab (3 cycles) followed by surgery, versus concomitant neoadjuvant pembrolizumab with platinum doublet chemotherapy (3 cycles) followed by surgery for participants with Stage IA3, IB and IIA non-small-cell lung cancer (NSCLC). Participants will be offered pembrolizumab (6 cycles), and standard of care adjuvant chemotherapy (4 cycles) if applicable.
Read the detailed description
The use of ctDNA levels and resolution in relation to treatment response has been studied in various types of cancer, notably melanoma, colorectal and pancreatic cancers. In pancreatic cancer, it was particularly noted to be useful for the prediction of recurrence and survival patterns. In NSCLC, there is a growing need to identify patients who are more likely to respond to immunotherapies given the rates of recurrence, and ctDNA was described to be a useful tool in the prediction of pathological response in this population. In fact, ctDNA was shown to correlate with disease resolution in NSCLC and higher levels of ctDNA in non-responding patients.
The central research question of this trial is focused on the ability to predict the occurrence of a pCR based on resolution of ctDNA detectability in early stage NSCLC. The biomarker collection plan will provide tumor and plasma samples from which whole exome sequencing will be performed to monitor disease response. The endpoint is focused on the elimination of ctDNA (both replicates = 0%) at the completion of systemic therapy, prior to surgical resection. All patients will be re-tested for ctDNA levels 30 days post-surgery to determine if those patients who did not experience ctDNA resolution after systemic therapy will experience resolution with the addition of surgery.
With the ctDNA treatment response arc, the investigators will be able to address the primary objective of the study: to establish ctDNA levels in early stage NSCLC as a reliable measure of local disease burden in the context of systemic therapy, with the lower end of the detection limit correlating to the extent of pathological response. The investigators hypothesize that in a cohort of patients with stage IA3, IB and IIA NSCLC, pre-operative pembrolizumab with or without histology-specific chemotherapy will cause resolution of ctDNA detectability that correlates with a pathological complete response (pCR) to therapy.
- Conditions
- Lung Cancer, Nonsmall Cell
- Being tested
- Pembrolizumab, Carboplatin, Paclitaxel, Pemetrexed
- Keywords
- Non-Small Cell Lung Cancer, Immunotherapy, Immune Checkpoint Inhibition, Early Stage Lung Cancer, Neoadjuvant Therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda, MK-3475
Neoadjuvant pembrolizumab 200 mg IV every 3 weeks, given on cycle day 1. Adjuvant pembrolizumab 400 mg IV every 6 weeks, given on cycle day 1.
CarboplatinDrug
Carboplatin AUC 6 IV (maximum dose: 900 mg) for squamous cell carcinoma, and AUC 5 IV (maximum dose: 750 mg) for non-squamous cell carcinoma, every 3 weeks, given on cycle day 1.
PaclitaxelDrug
Paclitaxel 200 mg/m2 IV every 3 weeks, given on cycle day 1. Only given to participants with squamous cell carcinoma.
PemetrexedDrug
Pemetrexed 500 mg/m2 every 3 weeks, given on cycle day 1. Only given to participants with non-squamous cell carcinoma.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant pembrolizumab + adjuvant pembrolizumab +/- adjuvant chemotherapy | Experimental | Neoadjuvant: Participants receive pembrolizumab [200 mg, intravenous (IV)] every 3 weeks for 3 cycles.
Adjuvant: Participants receive pembrolizumab [400 mg IV] every 6 weeks for 6 cycles, and may receive histology-specific adjuvant chemotherapy [consisting of carboplatin AUC 6 and paclitaxel 200 mg/m2, or carboplatin AUC 5 and paclitaxel 500 mg/m2] every 3 weeks for 4 cycles, if indicated. Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed |
| Neoadjuvant pembrolizumab and chemotherapy + adjuvant pembrolizumab +/- adjuvant chemotherapy | Experimental | Neoadjuvant: Participants receive pembrolizumab [200 mg, intravenous (IV)] every 3 weeks for 3 cycles in combination with standard of care histology-specific chemotherapy [consisting of carboplatin AUC 6 and paclitaxel 200 mg/m2, or carboplatin AUC 5 and paclitaxel 500 mg/m2] every 3 weeks for 3 cycles.
Adjuvant: Participants receive pembrolizumab [400 mg IV] every 6 weeks for 6 cycles, and may receive histology-specific adjuvant chemotherapy [consisting of carboplatin AUC 6 and paclitaxel 200 mg/m2, or carboplatin AUC 5 and paclitaxel 500 mg/m2] every 3 weeks for 4 cycles, if indicated. Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA resolution
ctDNA resolution is defined as the change or resolution in tumor-derived DNA found in the bloodstream from diagnosis to after neoadjuvant therapy and after surgery, correlated with pathological complete response (pCR).
Measured: Up to 2 years
Secondary outcomes (5)
Imaging measures of response
Imaging measures of response is defined as individual measures of response for conventional CT (quantification of response by RECIST 1.1 criteria), PET (change in standardized uptake values [SUV]) and diffusion-weighted MRI (change in apparent diffusion coefficient [ADC] obtained by image analysis software package), in correlation with pathological complete response (pCR).
Measured: Up to 3 years
Pathological complete response (pCR) rate
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Measured: Up to 3 years
Major pathological response (MPR) rate
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.
Measured: Up to 3 years
Adverse event (AE) rate
Number of participants experiencing AEs will be recorded. An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Measured: Up to 3 years
Perioperative complications rate
Number of participants experiencing perioperative complications will be recorded.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start28 Aug 2022
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Why it stopped: Study was terminated due to low recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Nonsmall CellStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Spicer, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Jonathan Spicer, MD, PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638582
- Sponsor's protocol ID
- MK3475-A74
- Status last verified
- Apr 2026
- First submitted
- 16 Nov 2020
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab or Pembrolizumab With Histology-Specific Chemotherapy for Operable Stage IA3 to IIA Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT04638582
- Acronym / sponsor ID
- MK3475-A74
- Conditions
- Lung Cancer, Nonsmall Cell
- Keywords
- Non-Small Cell Lung Cancer, Immunotherapy, Immune Checkpoint Inhibition, Early Stage Lung Cancer, Neoadjuvant Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to low recruitment.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 28 Aug 2022 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 20 Nov 2020 (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.
This is a prospective, randomized, single-site, open-label Phase II trial of neoadjuvant pembrolizumab (3 cycles) followed by surgery, versus concomitant neoadjuvant pembrolizumab with platinum doublet chemotherapy (3 cycles) followed by surgery for participants with Stage IA3, IB and IIA non-small-cell lung cancer (NSCLC). Participants will be offered pembrolizumab (6 cycles), and standard of care adjuvant chemotherapy (4 cycles) if applicable.
Detailed description
The use of ctDNA levels and resolution in relation to treatment response has been studied in various types of cancer, notably melanoma, colorectal and pancreatic cancers. In pancreatic cancer, it was particularly noted to be useful for the prediction of recurrence and survival patterns. In NSCLC, there is a growing need to identify patients who are more likely to respond to immunotherapies given the rates of recurrence, and ctDNA was described to be a useful tool in the prediction of pathological response in this population. In fact, ctDNA was shown to correlate with disease resolution in NSCLC and higher levels of ctDNA in non-responding patients.
The central research question of this trial is focused on the ability to predict the occurrence of a pCR based on resolution of ctDNA detectability in early stage NSCLC. The biomarker collection plan will provide tumor and plasma samples from which whole exome sequencing will be performed to monitor disease response. The endpoint is focused on the elimination of ctDNA (both replicates = 0%) at the completion of systemic therapy, prior to surgical resection. All patients will be re-tested for ctDNA levels 30 days post-surgery to determine if those patients who did not experience ctDNA resolution after systemic therapy will experience resolution with the addition of surgery.
With the ctDNA treatment response arc, the investigators will be able to address the primary objective of the study: to establish ctDNA levels in early stage NSCLC as a reliable measure of local disease burden in the context of systemic therapy, with the lower end of the detection limit correlating to the extent of pathological response. The investigators hypothesize that in a cohort of patients with stage IA3, IB and IIA NSCLC, pre-operative pembrolizumab with or without histology-specific chemotherapy will cause resolution of ctDNA detectability that correlates with a pathological complete response (pCR) to therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant pembrolizumab + adjuvant pembrolizumab +/- adjuvant chemotherapy | Experimental | Drug: Pembrolizumab, Drug: Carboplatin, Drug: Paclitaxel, Drug: PemetrexedNeoadjuvant: Participants receive pembrolizumab [200 mg, intravenous (IV)] every 3 weeks for 3 cycles. Adjuvant: Participants receive pembrolizumab [400 mg IV] every 6 weeks for 6 cycles, and may receive histology-specific adjuvant chemotherapy [consisting of carboplatin AUC 6 and paclitaxel 200 mg/m2, or carboplatin AUC 5 and paclitaxel 500 mg/m2] every 3 weeks for 4 cycles, if indicated. |
| Neoadjuvant pembrolizumab and chemotherapy + adjuvant pembrolizumab +/- adjuvant chemotherapy | Experimental | Drug: Pembrolizumab, Drug: Carboplatin, Drug: Paclitaxel, Drug: PemetrexedNeoadjuvant: Participants receive pembrolizumab [200 mg, intravenous (IV)] every 3 weeks for 3 cycles in combination with standard of care histology-specific chemotherapy [consisting of carboplatin AUC 6 and paclitaxel 200 mg/m2, or carboplatin AUC 5 and paclitaxel 500 mg/m2] every 3 weeks for 3 cycles. Adjuvant: Participants receive pembrolizumab [400 mg IV] every 6 weeks for 6 cycles, and may receive histology-specific adjuvant chemotherapy [consisting of carboplatin AUC 6 and paclitaxel 200 mg/m2, or carboplatin AUC 5 and paclitaxel 500 mg/m2] every 3 weeks for 4 cycles, if indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Previously untreated, histologically confirmed (by core biopsy) NSCLC and histologically confirmed stages IA3, IB and IIA NSCLC (AJCC 8th edition).
- Able to undergo protocol therapy, including necessary surgery.
- If female: may participate if no active pregnancy, not breastfeeding, and at least one of the following: is not a woman of childbearing potential (WOCBP), or is a WOCBP using contraceptive methods.
- If male: must agree to refrain from donating sperm, and must either be abstinent or agree to use contraception.
- ECOG 0-1
Key exclusion criteria (18 listed)
- Has one of the following tumor locations/types: NSCLC involving the superior sulcus, large cell neuroendocrine cancer (LCNEC) or sarcomatoid tumor.
- History of immunodeficiency, HBV, HCV, HIV. No HBV, HCV or HIV testing is required unless mandated by local health authority.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has had an allogenic tissue/solid organ transplant.
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 |
|---|---|---|
| PembrolizumabAlso: Keytruda, MK-3475Neoadjuvant pembrolizumab 200 mg IV every 3 weeks, given on cycle day 1. Adjuvant pembrolizumab 400 mg IV every 6 weeks, given on cycle day 1. | Drug | Neoadjuvant pembrolizumab + adjuvant pembrolizumab +/- adjuvant chemotherapy, Neoadjuvant pembrolizumab and chemotherapy + adjuvant pembrolizumab +/- adjuvant chemotherapy |
| CarboplatinCarboplatin AUC 6 IV (maximum dose: 900 mg) for squamous cell carcinoma, and AUC 5 IV (maximum dose: 750 mg) for non-squamous cell carcinoma, every 3 weeks, given on cycle day 1. | Drug | Neoadjuvant pembrolizumab + adjuvant pembrolizumab +/- adjuvant chemotherapy, Neoadjuvant pembrolizumab and chemotherapy + adjuvant pembrolizumab +/- adjuvant chemotherapy |
| PaclitaxelPaclitaxel 200 mg/m2 IV every 3 weeks, given on cycle day 1. Only given to participants with squamous cell carcinoma. | Drug | Neoadjuvant pembrolizumab + adjuvant pembrolizumab +/- adjuvant chemotherapy, Neoadjuvant pembrolizumab and chemotherapy + adjuvant pembrolizumab +/- adjuvant chemotherapy |
| PemetrexedPemetrexed 500 mg/m2 every 3 weeks, given on cycle day 1. Only given to participants with non-squamous cell carcinoma. | Drug | Neoadjuvant pembrolizumab + adjuvant pembrolizumab +/- adjuvant chemotherapy, Neoadjuvant pembrolizumab and chemotherapy + adjuvant pembrolizumab +/- adjuvant chemotherapy |
Primary outcome
ctDNA resolution
Time frame: Up to 2 years
ctDNA resolution is defined as the change or resolution in tumor-derived DNA found in the bloodstream from diagnosis to after neoadjuvant therapy and after surgery, correlated with pathological complete response (pCR).
5 secondary outcomes
Imaging measures of response
Time frame: Up to 3 years
Pathological complete response (pCR) rate
Time frame: Up to 3 years
Major pathological response (MPR) rate
Time frame: Up to 3 years
Adverse event (AE) rate
Time frame: Up to 3 years
Perioperative complications rate
Time frame: Up to 3 years
Results and safety
The study was stopped early (reason given: Study was terminated due to low recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- 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. This study is not recruiting at the moment.
Jonathan Spicer, MD, PhD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Lung Cancer, Nonsmall Cell, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 6 inclusion and 18 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: stopped early, as of the sponsor's last update on 17 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was terminated due to low recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA resolution (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2026.