← Back to Search

Monoclonal Antibodies

Pembrolizumab + Chemotherapy for Non-Small Cell Lung Cancer

Phase 2
Recruiting
Led By Jonathan Spicer, MD, PhD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
If male: must agree to refrain from donating sperm, and must either be abstinent or agree to use contraception
Previously untreated, histologically confirmed (by core biopsy) NSCLC and histologically confirmed stages IA3, IB and IIA NSCLC (AJCC 8th edition)
Must not have
NSCLC involving the superior sulcus, large cell neuroendocrine cancer (LCNEC) or sarcomatoid tumor
Known additional malignancy that is progressing or requires active treatment within the past (5 years)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Approved for 10 Other Conditions
No Placebo-Only Group
All Individual Drugs Already Approved

Summary

This trial tests a drug combo to treat Stage IA3, IB and IIA non-small-cell lung cancer (NSCLC). Those involved will receive pembrolizumab & chemotherapy, then surgery. Some may also get adjuvant chemotherapy.

Who is the study for?
This trial is for adults with early-stage Non-Small Cell Lung Cancer (NSCLC) who haven't been treated before. They must be physically well enough to handle the treatments and surgery, not pregnant or breastfeeding, and willing to use contraception. People can't join if they've had severe reactions to pembrolizumab or chemo drugs, recent radiation therapy, other cancer treatments or trials within 4 weeks, certain health conditions that could affect the trial results, a history of significant lung disease or immune disorders.
What is being tested?
The study tests neoadjuvant pembrolizumab alone versus pembrolizumab with platinum-based chemotherapy before surgery in NSCLC patients. It's randomized and open-label; some will also get standard adjuvant chemotherapy after surgery depending on their situation.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation in various organs, skin rashes, hormone gland problems (like thyroid), and flu-like symptoms. Chemotherapy can lead to nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man and agree not to donate sperm and to use birth control or remain abstinent.
Select...
My lung cancer is in an early stage and has not been treated yet.
Select...
I am fully active or can carry out light work.
Select...
I am fit for the treatment and any required surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My lung cancer is a specific type affecting the upper part of my lung, or is LCNEC or sarcomatoid.
Select...
I do not have another cancer that is getting worse or needs treatment in the last 5 years.
Select...
I have been treated with specific immune therapy drugs before.
Select...
I had radiotherapy over 2 weeks ago and have no side effects needing steroids.
Select...
I have received a transplant from another person.
Select...
I have had cancer treatment, including trial drugs, before now.
Select...
I have had lung inflammation not caused by an infection.
Select...
I am currently on medication for an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ctDNA resolution
Secondary study objectives
Adverse event (AE) rate
Imaging measures of response
Major pathological response (MPR) rate
+2 more
Other study objectives
Anatomical segmentectomy rate
Disease-free survival (DFS)
Imaging mass cytometry (IMC) panel analyses
+2 more

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Neoadjuvant pembrolizumab and chemotherapy + adjuvant pembrolizumab +/- adjuvant chemotherapyExperimental Treatment4 Interventions
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.
Group II: Neoadjuvant pembrolizumab + adjuvant pembrolizumab +/- adjuvant chemotherapyExperimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
FDA approved
Pembrolizumab
FDA approved
Carboplatin
FDA approved
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
467 Previous Clinical Trials
166,499 Total Patients Enrolled
Jonathan Spicer, MD, PhDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
2 Previous Clinical Trials
35 Total Patients Enrolled

Media Library

Pembrolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04638582 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Neoadjuvant pembrolizumab + adjuvant pembrolizumab +/- adjuvant chemotherapy, Neoadjuvant pembrolizumab and chemotherapy + adjuvant pembrolizumab +/- adjuvant chemotherapy
Non-Small Cell Lung Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04638582 — Phase 2
Pembrolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04638582 — Phase 2
~13 spots leftby Aug 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top