Study of Novel Treatment Combinations in Patients With Lung Cancer (NCT05633667) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Novel Treatment Combinations in Patients With Lung Cancer
United States, Brazil, Hong Kong192 participantsStarted 2023-03-16
Plain-language summary
The goal of this platform clinical trial is to test how well novel treatment combinations work in participants with lung cancer. Substudy-01 will compare the different novel combinations versus standard of care in participants with metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC) who have not been treated before. Substudy-02 will compare the different novel combination versus standard of care in participants with cancer that has progressed after receiving previous treatment for metastatic NSCLC. Substudy-03 will compare the different novel combinations versus standard of care in participants with resectable stage II-III NSCLC.
The primary objectives of this study are:
Substudy-01 and Substudy-02: To evaluate the objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Substudy-03: To evaluate the efficacy of treatment combinations based on complete pathological response (pCR) rate.
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.
Key Inclusion Criteria:
All Substudies:
* Histologically or cytologically documented non-small-cell lung cancer (NSCLC).
* No known actionable genomic alterations for which targeted therapies are available.
* Eastern cooperative oncology group (ECOG) performance status score of 0 or 1.
* Measurable disease per response evaluation criteria in solid tumors.
* Adequate hematologic and end-organ function.
* Individuals of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception.
Substudy 01: All Experimental arms
* Stage IV NSCLC.
* For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative.
* PD-L1 status by central confirmation.
* No prior systemic treatment for metastatic NSCLC.
Substudy 02: All Experimental arms
* Stage IV NSCLC.
* In individuals with nonsquamous histology and actionable EGFR, ALK, or other known genomic alterations must have received treatment with at least 1 targeted therapy to the appropriate genomic alteration.
Substudy 03: All Experimental arms
* Previously untreated individuals with resectable (Stage II, IIIA, IIIB (T\[3-4\]N2) NSCLC (per American Joint Committee on Cancer (AJCC) Edition 8).
* Planned surgery must comprise of lobectomy, sleeve lobectomy, or bi-lobectomy.
* PD-L1 status by central confirmation.
* For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplasti…
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
Substudies 01 and 02: Objective Response Rate (ORR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1