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Study with Various Immunotherapy Treatments in Participants With Lung Cancer
EU CTIS ID: 2022-502916-35-01
What this study is testing
To assess the objective response rate (ORR) of immunotherapy-based combination therapy To assess the safety and tolerability of immunotherapy-based combination therapy
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histologically or cytologically documented NSCLC with documented evidence of Stage IV metastatic NSCLC disease at the time of start of study treatment (per American Joint Committee on Cancer Version 8).
- ECOG performance status of 0 to 1.
- With ≥ 1 measurable target lesion(s) as per RECIST v1.1 criteria (Section 9.9) by investigator assessment. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Organ function requirement: Adequate hematologic counts, Adequate hepatic function, Creatinine clearance
- Participants must provide adequate pretreatment tumor tissue from non-irradiated locations, either as a formalin-fixed, paraffin-embedded (FFPE) tissue block or freshly sectioned slides. Bone biopsies, cytology, and fine needle aspirates are not acceptable Archived tumor tissue blocks are acceptable if they were collected within the past 12 months and no anticancer treatment was received between tissue collection and enrollment. If a suitable archival tumor tissue sample is not available, the participant must be willing to undergo a pretreatment tumor biopsy.
You likely can't join if
- Underlying medical conditions that, in the investigator’s or sponsor’s opinion, will make the administration of investigational products (IPs) hazardous
- Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s).
- Are receiving systemic steroids (> 10 mg/day prednisone equivalent) or other immunosuppressive medication ≤ 14 days before the initiation of the study treatment. Use of topical, inhalation, intranasal, and intraocular steroids will be permitted.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- Georgia
- United States
- Korea, Republic of
- Australia
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; Georgia; United States; Korea, Republic of; Australia; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.