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Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2/PHASE3

Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer

A Biomarker-Directed, Multi-Centre Phase II/III Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer

NCT04093167•Canadian Cancer Trials Group

Summary

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.

Detailed Description

This study is being done in two stages. Participants are being invited to participate in stage 2. The purpose of stage 1 of the study was to find out how soon ctDNA disappears from blood in patients with lung cancer treated with pembrolizumab and whether ctDNA disappearance or continued detection related to how well people did. In stage 2 the study will use the blood tests to figure out if patients on treatment with pembrolizumab with ctDNA that is still detected in the blood after 6 weeks of pembrolizumab could do better by adding standard chemotherapy treatment before the cancer is worse compared to continuing on standard pembrolizumab without added chemotherapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Confirmed EGFR and ALK mutation-negative disease based on testing consistent with local guidelines.
•Patients must have a PD-L1 test result from a certified laboratory indicating PD-L1 expression Tumour Proportion Score (TPS) ≥ 50%. Patients with lower PD-L1 TPS scores treated with single agent pembrolizumab consistent with local guidelines and regulatory approvals may be eligible following discussion with CCTG.
•Patients are to be registered prior to starting immunotherapy. Screening ctDNA is to be drawn following registration prior to starting immunotherapy and after not more than 2 cycles of the 200mg or 2mg/kg IV Q3W dose/schedule of pembrolizumab, or at least and not more than 1 cycle of 400mg or 4mg/kg IV Q6W dose/schedule of pembrolizumab as first-line systemic immunotherapy for advanced metastatic NSCLC at the time of. Eligible patients with detectable ctDNA at 6 weeks may proceed to enrollment and randomization.
•Prior chemotherapy or immunotherapy for non-metastatic disease (e.g. adjuvant and or neoadjuvant therapy) is allowed if at least 6 months have elapsed between the completion of prior therapy and start of pembrolizumab as first-line treatment for metastatic disease. Local therapy, e.g. palliative extra-cranial radiation, is allowed as long as a period of 2 weeks has passed since completion and screening as ctDNA levels may be altered by radiotherapy. There is no requirement for delay for patients who have received brain radiation.
•Patients must have recovered to ≤ grade 1 from all reversible toxicity related to prior systemic or radiation therapy.
•Previous major surgery is permitted provided that surgery occurred at least 14 days prior to screening of ctDNA and 28 days prior to patient enrollment and that wound healing has occurred.
•Eligible and suitable to receive continued treatment with pembrolizumab OR the addition of chemotherapy to pembrolizumab at the time of registration and again at the time of enrollment and randomization. Patients should be clinically stable without evidence of clinical progression or symptomatic deterioration that requires change in cancer treatment. Reimbursement of pembrolizumab may not be uniform across all sites. In the event that the site/investigator is unable to provide access to the drug, the patient will not be eligible for this trial.
•Must be ≥ 18 years of age.
•ECOG performance status 0-2.
•Clinically and/or radiologically documented and evaluable disease. Measurable disease as defined by RECIST is not required.
+15 more criteria

Exclusion Criteria

•Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the protocol treatment regimens are eligible for this trial.
•Patients with symptomatic central nervous system (CNS) metastases and/or CNS metastases requiring immunosuppressive doses of systemic corticosteroids (\>10 mg/day prednisone equivalents). Patients with known central nervous system metastases who are asymptomatic and on a stable dose of corticosteroids ≤ 10 mg/day prednisone equivalents are eligible.
•Patients who are not suitable candidates for treatment with pembrolizumab as a single agent or in combination with standard platinum combination chemotherapy according to the current guidance/indications described in the Product Monograph (Canada) or Drug Label (U.S.) and practice guidelines including but not limited to patients with active infection, autoimmune disease, conditions that require systemic immunosuppressive therapy (such as transplant patients) and patients with a history of severe immune-mediated adverse reactions, or known hypersensitivity to pembrolizumab or its components. Patients with pre-existing conditions such as colitis, hepatic impairment, respiratory or endocrine disorders (such as hypo or hyperthyroidism or diabetes mellitus), can be considered for enrollment to this study provided pembrolizumab is administered with caution and patients are closely monitored. Patients should not have contraindications to platinum combination chemotherapy.
•History of significant neurologic or psychiatric disorder that would impair the ability to obtain consent or limit compliance with study requirements.
•Concurrent treatment with other anti-cancer therapy or other investigational anti-cancer agents
•Pregnant or lactating women.

Locations (10)

The University of Chicago Medical Center

Chicago, Illinois, United States

The Sidney Kimmel Comprehensive Cancer Centre

Baltimore, Maryland, United States

BCCA - Vancouver

Vancouver, British Columbia, Canada

Health Sciences North

Greater Sudbury, Ontario, Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Algoma District Cancer Program

Sault Ste. Marie, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

The Jewish General Hospital

Montreal, Quebec, Canada

Key Dates

Start Date

May 26, 2020

Primary Completion Date

December 31, 2026

Completion Date

July 30, 2027

Last Updated

March 11, 2026

Enrollment

230

ESTIMATED participants

Conditions

Lung Cancer

Interventions

Pembrolizumab

DRUG

Contacts

Janet Dancey

CONTACT

613-533-6430 jdancey@ctg.queensu.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer

Inclusion Criteria

Exclusion Criteria

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