From Liquid Biopsy to Cure: Using ctDNA Detection of Minimal Residual Disease to Identify Patients for Curative Therapy After Lung Cancer Resection

Who is this study for? People with lung cancer
What treatments are being studied? Nivolumab+Pemetrexed+Gemcitabine+Cisplatin+Carboplatin+ctDNA blood test
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a study to look at whether the presence of circulating tumour DNA (ctDNA) in the blood can help to predict whether giving adjuvant treatment after surgery can decrease the chance of the cancer coming back in people with lung cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years at the time of screening

• Written informed consent obtained from the subject prior to performing any protocol-related procedures

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Weight ≥ 35 kg

• Must have a life expectancy of at least 24 months

• Complete surgical resection of T1-2N0M0 NSCLC or T3/T4 multifocal NSCLC

• Any pathologic subtype of NSCLC is eligible, including adenocarcinoma and squamous carcinoma. Patients with targetable genomic alterations without approved or available targeted adjuvant therapy options are eligible

• Patients with detectable plasma ctDNA before or after complete surgical resection are eligible (RaDaR TM assay, Inivata Morrisville, North Carolina, USA).

• No prior chemotherapy or radiotherapy is allowed for the current diagnosis of resected NSCLC.

⁃ Adequate organ and marrow function as defined in Table 4 (3.1.1)

⁃ Females of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception from screening to 180 days after the final dose of study treatment. A serum pregnancy test within 72 hours prior to the initiation of therapy will be required for women of childbearing potential. It is strongly recommended for the male partner of a female subject to also use male condom plus spermicide throughout this period

⁃ Non-sterilized male subjects who are sexually active with a female partner of childbearing potential must use a male condom with spermicide from screening to 180 days after receipt of the final dose of study treatment. It is strongly recommended for the female partner of a male subject to also use a highly effective method of contraception throughout this period. In addition, male subjects must refrain from sperm donation while on study and for 180 days after the final dose of study treatment.

Locations
Other Locations
Canada
Princess Margaret Cancer Centre
RECRUITING
Toronto
Contact Information
Primary
Natasha Leighl, M.D.
Natasha.Leighl@uhn.ca
416-946-4645
Time Frame
Start Date: 2022-03-28
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 66
Treatments
Experimental: Adjuvant chemo-immunotherapy therapy
All participants will have blood taken for ctDNA testing.~A cycle is 21 days. Pemetrexed (for participants with non-squamous non-small cell lung cancer), intravenously (by vein) on Day 1 of Cycles 1-4, OR gemcitabine (for all other participants) on Days 1 and 8 of Cycles 1-4.~Cisplatin\*, intravenously (by vein) on Day 1 of Cycles 1-4 Nivolumab, intravenously (by vein) on Day 1 of Cycles 1-4~\*If cisplatin is not tolerated, carboplatin may be given instead
Other: Observation
All participants will have blood taken for ctDNA testing.~Participants will be followed as per standard of care every 3 months.
Sponsors
Collaborators: Bristol-Myers Squibb
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov