NeoTRACK - Dissection of IO Efficacy in NSCLC by Longitudinal tracKing (NCT05825625) | Clinical Trial Compass
Active — Not RecruitingPhase 2
NeoTRACK - Dissection of IO Efficacy in NSCLC by Longitudinal tracKing
Germany35 participantsStarted 2023-05-26
Plain-language summary
Prospective, non-randomized, open-label, single-arm phase II trial to investigate the feasibility and efficacy of combining chemotherapy with tiragolumab and atezolizumab as neoadjuvant and adjuvant treatment for surgical NSCLC patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Has provided written informed consent
. Patient\* 18 years or older at time of signing informed consent form
. Histologically confirmed NSCLC of squamous or non-squamous histology
. Resectable clinical stage II, IIIA and IIIB (T3N2 only) NSCLC (according to UICC 8)
. Adequate disease staging by PET and/or CT as per SOC (performed ≤ 42 days prior initiation of the study treatment)
. At least 1 measurable lesion according to RECIST v1.1
. ECOG performance status ≤ 1
. Adequate lung and cardiac function for curative intend lung resection (R0) according to German S3 guideline
Exclusion criteria
. Treatment in any other clinical trial with an investigational product within 30 days before screening
. Clinical stage I, IIIB (T4N2), IIIC, nodal NSCLC stage cN3 and stage IV NSCLC
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
MPR rate after curative intent surgery
Timeframe: 12 weeks
Trial details
NCT IDNCT05825625
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
. Positive testing of activating (TKI-responsive) EGFR-mutation, ROS1-mutation or known ALK fusion oncogene
. Expected pneumonectomy at baseline to achieve curative intend resection
. Any concurrent chemotherapy, investigational product (IMP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (e.g. hormone replacement therapy) is acceptable.
. Malignancies other than NSCLC within 3 years prior to study inclusion with the exception of malignancies with a negligible risk of metastases or death (5-year OS \> 90%) like localized prostate cancer, ductal carcinoma in situ, adequately treated carcinoma in situ of the cervix, Stage I uterine cancer, in-situ bladder cancer treated by BCG-Instillation, or non-melanoma skin carcinoma
. History of allogeneic tissue / solid organ transplant or allogeneic stem cell transplantation