Actively Recruiting
Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer
Led by Canadian Cancer Trials Group · Updated on 2026-03-11
230
Participants Needed
10
Research Sites
374 weeks
Total Duration
On this page
Sponsors
C
Canadian Cancer Trials Group
Lead Sponsor
C
Cancer Research Institute, New York City
Collaborating Sponsor
AI-Summary
What this Trial Is About
The standard or usual treatment for this disease is pembrolizumab given by needle into the veins (IV). Some cancers shed DNA (circulating tumour DNA or ctDNA) or genes (biomarkers) into the blood, and levels of these biomarkers may be able to tell researchers how people respond to treatment with pembrolizumab before they feel worse, or the cancer is worse on imaging tests. Researchers are studying how levels of these biomarkers can show how cancers are responding to treatment and whether adding chemotherapy to pembrolizumab based on detection of ctDNA can offer better results.
CONDITIONS
Official Title
Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic NSCLC, or stage III if not a candidate for surgery or definitive chemoradiation
- Confirmed EGFR and ALK mutation-negative disease per local testing guidelines
- PD-L1 Tumor Proportion Score (TPS) of 50% or higher, or lower scores if eligible per local guidelines
- Registration before starting pembrolizumab immunotherapy and blood draw for ctDNA screening
- Detectable ctDNA at 6 weeks after starting pembrolizumab required for enrollment and randomization
- Prior chemotherapy or immunotherapy allowed if completed at least 6 months before starting pembrolizumab for metastatic disease
- Recovery to grade 1 or less from previous treatment toxicities
- Major surgery at least 14 days before ctDNA screening and 28 days before enrollment with healed wounds
- Eligibility and suitability for pembrolizumab with or without added chemotherapy at registration and enrollment
- Age 18 years or older
- ECOG performance status 0 to 2
- Clinically or radiologically documented evaluable disease; measurable disease not required
- Recent imaging within 14 days before randomization showing no progression requiring treatment change
- RECIST non-progressive or clinically stable disease before enrollment
- Adequate blood counts and organ function prior to registration and enrollment
- Consent to provide tumor tissue for analysis if available
- Willingness and ability to attend treatment and follow-up visits
- Beginning protocol treatment within 5 working days of randomization
- Use of effective contraception during treatment and for 6 months after final dose for participants of childbearing potential
You will not qualify if you...
- Patients with Large Cell Neuroendocrine Carcinoma (LCNEC)
- Symptomatic central nervous system metastases or those requiring high-dose corticosteroids
- Unsuitable for pembrolizumab or platinum chemotherapy due to active infection, autoimmune disease, immunosuppressive therapy, or severe immune reactions
- History of severe neurological or psychiatric conditions affecting consent or compliance
- Receiving other anti-cancer or investigational treatments concurrently
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
2
The Sidney Kimmel Comprehensive Cancer Centre
Baltimore, Maryland, United States, 21231
Actively Recruiting
3
BCCA - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
4
Health Sciences North
Greater Sudbury, Ontario, Canada, P3E 5J1
Actively Recruiting
5
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
6
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
7
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
8
Algoma District Cancer Program
Sault Ste. Marie, Ontario, Canada, P6B 0A8
Actively Recruiting
9
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
10
The Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
Research Team
J
Janet Dancey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here